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Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Pnntrnl  if 

nfciOU  L/dLc  / 

MOLIUll  wlllLrC 

oiyiidLure/  rietjUebLci 

ouujeoi 

Due  Date 

2012-7044 

10/01/2012 

FDA/OMPT/GDFR/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  W  L/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

Raphpl  .Inhn^nn 

1  IQ<jI  ICI   uUI  II  1 

NDA  214^^ 

1  >J  L/ 1  \  L—  1  '~V\J\J 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  \J  L/  1  1  1/  W  III    /  [_/  1 1  '  1  / 

FOI  f^prvippQ  \nr 

1    V_/ 1    UCI  VIVjCO.    II  1  \j . 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  V_/  III    /  t — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      11  \J  1— /  1  1  1/  V_/  III    /  L/  1  L/  1  / 

2012-7045 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  £_ 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    i  '  1  \/   /  1 V  1  1      1  /  \_/  L-/  1  11   1/  V  /  \_/  1  1  1/  1      1   '  1/ 

Rarhpl  .Inhn^nn 

1  IClv/l  Ivl   \J\Jl  II  IOV/1  1 

LAERDAL  MEDICAL  STAVANGER  NORWAY  -  EIR  483 

1  t  \  \  1  1 1 — /  /  \  1       1 V 1  1— —  L/  1  Vw/  /  \  1  j    v/  1  V  \  V  t  \  1  X  Vw/  1  1  I  ■    IN  Vw/  1  1  V  V  i  \  1          1  II   \  ,      l  L/  w  , 

10/30/2012 

FOI  Services,  Inc. 

CORR  06/20-23/201 1 

^01  ^-7046 

10/01/^01^ 

FUA/OMr  1  /CocKA/COD/DUOM/ 

Hita  Onoi 

FINANCIAL  CONrLIC  I  WAIVtKb,  OUtK  AND  CbtK 

10/30/2012 

ALFB/ 

George  Mason  Law  &  Economic 

ADVISORY  COMM  MEETINGS  -  1997  TO  2002 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V/  III    /  1— '  1  L/  1  / 

V/CI  1  LC 1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7047 

10/01/2012 

1  V//  W  1  /  C—\J  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  '  /    V/   Vw/  1  V  1  1          1    /  Vw /  lw/  1         |     1/   W  III       /    lw/  |  J  /  |  / 

Rachpl  .Inhn^nn 

1  IClv/l  1  v/ 1  UUI  II  IOV/1  1 

NDA  21858  -  LABELING  (CERTIFIED 

1  >l  1 — '  1  \  L—  1  V/  Sw*  V/        l_/  V 1  }  \  UN  X  Vw/    1  V/  1  1  1  1  1  1    1  1  1  L/  J 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  /  V/  Vw/ 1 V  1  1      11  \J  1—/  1  1  1/  V/  III    /  1— '  1  1  '  1  / 

FOI  Sprvippci  Inr 

1    Vw/ 1   UCI  VluUO)    II  lv/- 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    L/  /  V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V_/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7048 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  I — '  1  ]  /  1  / 

Annplia  filavtnn 

ni  lUviiu  vj iC4 y  iv/ 1  i 

PATHEON  MISSISSAUGA  ONTARIO  CANADA -EIR  483 

1     /  \  1  1   1  1  \S  1  *J  ,    1 V  1  1  U  V/  1  V/  v//\  V/  V_/  /  \  ,    Vw/  1  *l  1  l  \  1  1  1  Vw/  1    Vw/  /  VI  N  /  V  L/ 1  \        l_  II  I  .      i  VJ  w  , 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 

CORR  02/01/12  TO  07/31/12 

FDA/OMPT/CDER/ORP/DIDP/ 

SUBMISSIONS 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7049 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  lw/  1  J  /  1  / 

Rarhpl  Johnson 

1  Idv/I  1  v/ 1  UUI  II  IOV/1  1 

NDA  21455  -  LABELING  (CERTIFIED! 

1  *J  L/  /  V  L—  1     i  \J  v/        I  /  V I  >  \  I  1  1  >l  V_/    \  *^-/  1—  1  1  1   1  1     1  1— —  L/  J 

10/^0/201? 

FDA/OMPT/CDFR/ORP/DIDP/ 

FOI  ^pn/ippQ  Inr* 

1    Vw/ 1   OCl  VlUt/O,    II  \Kj. 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    L/  /  V/  Vw/ 1 V  1 1      1  /  \w/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7050 

10/01/2012 

FDA/OGROP/ORA/CE-FO/BLT- 

Rachel  Johnson 

EPIPEN  -  CORR  RE  MALFUNCTIONS  OR  EFFICACY 

10/30/2012 

DO/BLT-CB/ 

FOI  Services,  Inc. 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    )  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7051 

10/01/2012 

1  V//  v/  1  /  t —  V/  I  L — 

FDA/OF/CFSAN/OCD/EOS/ 

Maria  Amodio 

FCN  475 

10/30/2012 

ITT  A 

2012-7052 

10/01/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Maria  Amodio 

FCN  178 

10/30/2012 

ITT  A 

Page  1  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7053 

10/01/2012 
10/30/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

LIST  OF  TOBACCO  PRODUCTS  MANUFACTURED, 
PREPARED,  COMPOUNDED  ETC  THAT  HAVE  NOTIFIED  FDA 
OF  DISCONTINUANCE 

2012-7054 

10/01/2012 
10/30/2012 

ORA/ORM/ 
ORA/ORM/ 

Joseph  Anderson 
Joseph  Anderson 

LIST  OF  DOMESTIC  AND  INTERNATIONAL  INSPECTIONS  - 
SPONSOR,  MONITOR,  CRO  01/01/1990  -  12/31/201 1 

2012-7055 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  1 — /  I  L/  I  / 

ZYLOPRIM  -  AERS 

I—  A  1  Vw/  1     1  IMVI        nl  [  1  Vw/ 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Takeda  Global  Research  & 
Development  Cen 

2012-7056 

10/01/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

GARDISIL  -  VAERS 

10/30/2012 

ALFB/ 

Margaret  Schumacher 

2012-7057 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/BLT- 
DO/BLT-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

NEXT  BREATH  LLC,  BALTIMORE,  MD  -  EIR,  483,  CORR 
02/01/12-07/31/12 

2012-7058 

10/01/2012 
10/30/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OC/OES/DFOI/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

PFIZER,  INC,  KALAMAZOO,  Ml  -  EIR,  483,  CORR  02/01/12- 
07/31/12 

2012-7059 

10/01/2012 
10/30/2012 

i —  i- \  a  //""vy""**  n /~\ n  //~v n  a  /km —  i — /""\  /k 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

k  i/~\  ni  a  / 1  /™v  ii  ni  i  a  r™i  n  a    m  /~\  i — i  \  ■  i  ■  /—» ■  ■     k  i  \  /  i —  ■  n     Ann    /-v/~v  r™t  n 

NORWICH  PHARM,  NORWICH,  NY  -  EIR,  483,  CORR 
02/01/12-07/31/12 

2012-7060 

10/01/2012 

1  \JI  \J  1  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  v  1  1          11   \  '  L/  1  1     1/   \w/  III       /    1  '   1  IS  1  / 

Annplia  Rlavton 

ni  ly  v;  1 1  ci  wict y  iwi  i 

PATHEON  INC  ONTARIO  CANADA  -  EIR  483  CORR 

1     /  \  1  1   1  1  Vw/  1  N  .    1 1  VI  V/  ,    \—S  1  *l  1  I  \  III  Vw/  ,    Vw/ 1  \  1  VI 1  \  l_/ 1  \          1  II  l  ,      r  V/  V/  j    Vw/  Vw/  1  1 1  I 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

02/01/12-07/31/12 

2012-7061 

L_  \_/    1   £_      /    \J\J  1 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L*/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

Annplia  Slavtnn 

PATHEON  INC  ONTARIO  CANADA  -  EIR  483  CORR 

i    /  \  i  i  1 1  Vw/ 1  n  .  1 1  vi  v/  ,  Vw/ 1  vi  i  / \  iii  Vw/ ,  Vw/  /  v  i  vi  /  v  i  /  / \        i  ii  i ,    t  v/  o  ^  v/  Vw/ 1  1 1  i 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  l_/  1  1  1/  W  III    /  L/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

02/01/12-07/31/12 

2012-7062 

10/01/2012 
10/30/2012 

FDA/OC/OES/DFOI/ 

Megan  Pickel 

Beveridge  &  Diamond,  PC 

CFSAN  FOIA  REQUESTS  08/31/2012  -  09/27/2012 

<£01^-7063 

1 0/01/^01  cL 
10/30/2012 

rUA/UuKOrVUKA/bW-rO/KAN- 
DO/KAN-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

UNIVtKbl  1  Y  Or  IOWA,  rHAKIvl  btKVIGtb  UlvlblUN,  IUWA 
CITY,  IA  -  EIR,  483,  CORR  02/01/12-07/31/12 

2012-7064 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Mary  Lillian  Walker 

ISR  6545173,  7251443 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Foltz  Martin  Hudson  &  Knapp,  LLC 

Page  2  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

FDA/DMPT/nnFR/nRP/nmp/ 

i  \—st\/  v_/ivi  i   i  /  \j  is  \  n/  \j  ill  / \s 1 1_/ 1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7065 

10/01/2012 

FDA/OGROP/ORA/CE-FO/CIN- 

Angelia  Slayton 

WEST  ANALYTICAL  SERVICES,  LLC  -  MAUMEE,  OH  EIR, 

10/30/2012 

DO/CIN-OB/ 

INC  RESEARCH  CONSULTING  & 

483  CORR  02/01/12-07/31/12 

SUBMISSIONS 

2012-7066 

10/01/2012 

F  D  A/OG  ROP/O  R  A/C  E-  FO/B  LT- 

Angelia  Slayton 

PHARMACEUTICS  INTERNATIONAL,  HUNT  VALLEY,  MD  - 

10/30/2012 

DO/RI  T-HR/ 

INC  RESEARCH  CONSULTING  & 

FIR  48^  P.ORR  02/01/1  r?-(\ll'\\l\'? 
i  1 1  i ,  too,  v_/v_/ n n        \j  \  i  \  c  \j  /  /  o  i  /  i  c- 

bUBMISSIONS 

2012-7067 

10/01/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

NUSKIN  -  INQUIRIES  RE  GALVANIC  SPA  DEVICE,  AGELOC, 

10/30/2012 

DO/LOS-CB/ 

HIGHSIDE  CAPITAL 

ETC 

FDA/OMPT/GDRH/OGER/DFOI/ 

MANAGEMENT 

FDA/OGROP/ORA/SW-FO/DEN- 

DO/DEN-CB/ 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

2012-7068 

10/01/2012 

FDA/OGROP/ORA/PA-FO/SAN- 

Angelia  Slayton 

MECOMM  SOLUTIONS,  EMERYVILLE,  CA  -  EIR,  483,  CORR 

10/30/2012 

DO/SAN-CB/ 

INC  RESEARCH  CONSULTING  & 

02/01/12-07/31/12 

O  \J  EJ 1 VI IOOIUI  NO 

2012-7069 

10/01/2012 

FDA/OGROP/ORA/PA-FO/SEA- 

TRIDENT  SEAFOODS  CORP,  SEATTLE,  WA  -  INSPECTION 

10/30/2012 

DO/SEA-CB/ 

Doe  J 

REPORTS,  SAMPLE  RESULTS,  COMPLAINTS,  ETC 

2012-7070 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  Lh'  1  1  1/  \S  III    /  1— /  1  L-/  1  / 

Mirhapl  Dprhv 

IND  SPONSOR  -  DEFLAZACORT  IN  TREATMENT  OF 

1  1  M  IS    *S  1     Vw/ 1  i|  \s  Nw -*  1  I        IS  1  1    1—t  \£.  I  \  \S  \S  III     1  1  X     III  1—  1  V  1  1  v  1  1—  1  M  1     \w/  1 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Norphan  Pharmaceuticals,  Inc. 

DUCHENNE  MUSCULAR  DYSTROPHY 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7071 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

Mirhapl  Salinas 

IVIIV^I                WUlll  IUO 

LASIX  -  AERS 

1  t  \  \s  1  /  \        l  \  1—  1  l  \s 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '       1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

Mirhapl  fialin^^ 

IVIIV^I  IUt>l   WC4.III  ICIO 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7072 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

lona  Evans 

VIROPHARMA  -  MEETINGS,  MINUTES,  CORR  RE  NDA  50606, 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Labaton  Sucharow  LLP 

AMENDMENTS,  ACTION  LETTER,  ETC  . 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/OCC/ 

OM/OMP/DODM/ 

Page  3  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7073 

10/01/2012 
10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  \J  IS  1  1  1/  W  III    /  IS  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Cihlnp  RirH  anH/nr  Fphipn  7aorprrln 
PCCA 

LIST  OF  FOREIGN  IMPORTED  DRUG  PRODUCTS  LIST  OF 

1  1 V  '  1     \J  \       1    Vw/ 1  11  IVJI  N    llvll     Vw/ 1  1  1  1  IS    IS  1  1  U          1     1  1V/L/U  V/  1  VJ  j    LIVJ  1     Vw/ 1 

NDC  NUMBERS 

2012-7074 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Fort  Lauderdale  Sun-Sentinel 

HCG - AERS 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OF/CFSAN/OCD/EOS/ 

Fort  1  audprdalp  ftun-Spntinpl 

1    V/l  1   1_QUUVI  UulU             1  1    \J\j  1  1  11 1  1  \j  1 

2012-7075 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  L*/  1  1  /  1  / 

.lanpt  MrChri^tinn 

UUl  Ivl   IVIWv/l  II  IOLIV/1  1 

ANDA  200837  201048  202563  ETC  -  APPROVAL  LETTERS 

/  VI  N  IS  1  I  L—  \J\J\J\J  1  ^    L—  \J  1  \J    i  *S  ,    t_ V/ L_ v_y  V/ V./  ,    l_  1  \w/          /  \  1     1     1  1  Vw/  V  /  \  1       l_ l_  1     1  l_  1  I \J 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  \S  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Fresenius  Kabi  LLC  USA 

2012-7076 

10/01/2012 

1  \Jl  \J  1  /  t—\J  1  L 

10/30/2012 

CVM/OCD/ 

Kandarn  Praianati 

1  \CA.\  IVJ  Cll  k/    1     1  ClJuUClU 

Advantagene  Inc. 

NADA  006475  -  FOIA  SUMMARY 

1  Ml V  IS  1  I  \_/  \J  V/      /  \J        1    Vw/  1  /  \  \J  kw7  1 V  1 1 V  1  /  \  III 

2012-7077 

10/01/2012 
10/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Amlendu  Prabhakar 

ARIZONA  STATE  UNIVERSITY 

I  \  1  l  1 L  Vw/ 1  HI \  \S  1  i  \  1  1— —    V  '  1  11  V  l_  1  I \S  1  1  1 

K875029 

2012-7078 

10/01/2012 
10/30/2012 

OM/OSS/OPILS/FDAHO/ 

OM/OMP/DODM/ 

OM/OMP/DODM/ 

NORWEGIAN  UNIV  OF  SCIENCE 
AND  TECHNOLOGY 

FDA-NIMN  PSYCHOTOMIMETIC  AGENCY  ADVISORY  COMM 
-  MEETING  RECS  01/01/1967  -  12/31/1975 

2012-7079 

10/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

Mahi  Dpliniani^ 

Ivldl  II    *S  v/ 1 1  \J  1  C4 1  HO 

08/01/96  LTR  FROM  DDMAC  TO  PFIZER  RE  ZOLOFT 

\J\Jl  \J  \  1  \J  \J    Lb  1  1  1    1    11  \S  1  V 1    IS  IS  1  V  1 1  \  \S     1  Vw/    1     1     1 L  1  1  1    1  1 1_   L  Vw/  L_  \S  1  1 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Mahi  Deligiannis 

2012-7080 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

PHARMAGISTICS,  LLC,  SOMERSET,  NJ  -  EIR,  483,  CORR 
02/01/12-07/31/12 

2012-7081 

10/01/2012 
10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  L-/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Annplia  Slav/ton 

ni  lUviiu  vj iC4 y  WJ\  i 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

PATHEON  INC  BOURGOIN-JALLIEU  CEDEX  FRANCE  - 

1     /  l  1  1   1  1  Vw/  1  N    111  Vw/  j  1— /  Vw/  V/  1  1  Vwl  Vw/  111    \J  1  \  1  1  1  l_  V/  ,  Vw /  l_  L/  1  /  V  ,    1    1  1 1  \  \  N  Vw /  1  

EIR,  483,  CORR  02/01/12-07/31/12 

2012-7082 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

PACE  ANALYTICAL  LIFE  SCIENCES,  LLC,  OAKDALE,  MN  - 
EIR,  483,  CORR  02/01/12-07/31/12 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7083 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

UPS  SUPPLY  CHAIN  SOLUTIONS  (UNIT  C&D),  RENO,  NV  - 
EIR,  483,  CORR  02/01/12-07/31/12 

2012-7084 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

UPS  SUPPLY  CHAIN  SOLUTIONS,  LOUISVILLE,  KY  -  EIR, 
483,  CORR  02/01/12-07/31/12 

2012-7085 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

LANCASTER  LABORATORIES,  LANCASTER,  PA  -  EIR,  483, 
CORR  02/01/12-07/31/12 

2012-7086 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

KNIPPER  &  CO,  INC,  LAKEWOOD,  NJ  -  EIR,  483,  CORR 
02/01/12-07/31/12 

2012-7087 

10/01/2012 

1  \JI  \J  1  /  t—\J  1  £— 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  IS  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SANJAY  H  SHARMA 
HETERO  USA  INC 

ACTONEL  (RISEDRONATE^  (SODIUM!  TABS  -  CHEMISTRY 

/  V  Vw/  1  \S  1  *J  1—  1       11   11  \S  l__  IS  1  l  \S  1  N  1  \  1  1      /    \  \s  \S  IS  1  K-J  1 V  1  J     1  /  V  IS  V/        \-J  1   1  1—  1  V  1  1  \S  1  1  I  1 

RVWS,  BIOEQV  RVWS,  ADMINISTRATIVE  RECS,  ETC 

2012-7088 

10/01/2012 
10/30/2012 

FDA/OMPT/CTP/OD/ 

LILI  SAWAN 
Sawan,  Lili 

CIGARETTES  -  LIST  OF  INGREDIENTS 

2012-7089 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      11  \S  L/  1  1  1/  W  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ADRIENNE  E  FAERBER 

I  \  IS  1  l  1  1  1  VI  <l  1        l__    1    /  V 1  1  I  IS  1  1  1 

DARTMOUTH  INSTITUTE 

ARICEPT  (DONEPEZIL!  NDA  20-690  -  APRVL  LTR  MEDICAL 

/  \  1  1 1  V  '  l_  1      1     1  IS  \s  \  H  1  1     1  L  1  1  J    1  \  \S  1  \  £_  \J    \J\J\J        I  \  1     1  1  V  L   L  1  1  1^    IVI  1  \S  1  \S  1  V  L_ 

RVWS,  STATITICAL  RVWS,  ADMINISTATIVE  RVWS,  ETC 

2012-7090 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Annplia  Slavtnn 

ni  \\A\jWO.  uiuy  lui  i 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

LABOR  L  &  S  AG  BAD  BOCKLET-GROSSENBRACH 

1  t  \  IS  Vw/  1  1   L   LX    *S  l  \  \—A  j    IS  l  \  IS    IS)  V-/  \S  1  \  1  l__  1            1  I  Vw/  Vw/  *w/  l__  1  M  IS  1  I  /  V  V/  1   1  , 

GERMANY  -  EIR,  483,  CORR  02/01/12-07/31/12 

2012-7091 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \  '  IS  1  1  1/  \S  III    /  IS  1  L-/  1  / 

JODY  LL  GREEN 

%j  Vw/  is  i    i_  i_  \s\  i  1 1  i  i  vi 

COUGH  &  COLD  PREPARATIONS  -  ISRS  8255706-3 

V/  Vw/  V/  Vwl  1   1    m   V/  Vw/  1—  IS    1     1  1 1  1     /  V 1   it  \  1  1  \s  1  N  V^/        1       1  l  U   V/ l_      J  /  V/  V/    Vw*  ^ 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ROCKY  MOUNTAIN  POISON 
DRUG  CTR 

8259298-4,  8261197-9,  ETC 

2012-7092 

10/01/2012 
10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Annplia  Slavton 

/» i  i  y  \-*  1 1       v*/  i  uy  iv/  i  i 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

MICRONISIERUNGS-KONTOR  OBERROT  GMBH,  OBERROT, 
GERMANY  -  EIR,  483,  CORR  02/01/12-07/31/12 

Page  5  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7093 

10/01/2012 
10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

G  CALEB  ALEXANDER 

\-A   \S  1  \  1  1  IS  I  \  \  1  /\f  V 1  \J  IS  1  1  l 

JOHN  HOPKINS  BLOOMBERG 
SCHOOL  OF  PUBLIC  HEALTH 

ABSTRALCFENTANYL  CITRATE1  NDA  22-510-  ACTIO 

nuu  i  i  1 1  \ \  1 1  i  i  >j  i  i  \ \  m  i  i     \j  \  i  i  in  ii  i  \  \  \s  1  \  L—  C—  — '  \  \j  .  1  \ Vw/  i  i  Vjc 

(FENTANYL  CITRATE)  NDA  20-747;  BUTRANS 
(BUPRENOPHINE)  NDA  21-306,  ETC  -  EVALUATION,  CORR, 
MEMOS,  ETC 

2012-7094 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  V  '  L_/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WAYNE  SADOWSKI 

V  V  1  \  1  1  N  1        *S  1  \  IS  \S  V  V  \—/  1  \  1 

NOVARTIS  PHARMACEUTICALS 
CORP 

DR  PREDRAG  MINIC  BELGARDE  SERBIA  7/2-6/12'  DR 

\S  ill    ill  IS  i  iriv/  I  V 1 1 1  N  I  \j  ,  is  I  I  v  \  I  \  \  \  IS  i  ,  \j  i  i  \  \  )  \  r\  /  I  C—  \ji  I  C—  .  is  1  1 

TORU  SATOH,  TOYKO,  JAPAN  7/9-13/12;  DR  EKKEHARD 
GRUENIG,  HEIDELBERG,  GERMANY  7/23-27/12,  ETC  -  EIRS, 
483S,  482S,  ETC 

2012-7095 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L_/  1  1  1/  \w/  III    /  1 — ^  1  Lri/  1  / 

MINOXIDIL  -  AERS 

i  v  1 1 1  *i  Vw/  /vi  is  1 1_      /  v  i  i  i  Vw* 

10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  \  1  1/  W  III    /  \S  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

GORDON,  KAREN 

2012-7096 

10/01/2012 

1  \Jl  \J  1  /  L—\J   1  I— 

FDA/OC/OES/DFOI/ 

MICHAEL  NAZERIAS 

TRIAD  MACON  GA  MOBILE  AL  CHARLESTON  SC  ETC  - 

1  1  1 1 1  V  IS  ,    1 V 1 1  \  \S  Vw/  1  N  ,    \Si\\    1  V 1  Vw/  IS  1  1  l_  ,    1  \  \  .    \S  1    1  /  \l  1  LLW  1  Vw/  1  VI  ,    w  w  •    1       1  w 

10/30/2012 

FDA/OC/OES/DFOI/ 

PETNET  SOLUTIONS  INC 

EIRS,  483S 

2012-7097 

10/01/2012 
10/30/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

JOHN  PAUL 
HUBBARD-HALL  INC 

HUBBARD-HALL  INC,  WATERBURY,  CT  -  EIRS  10/13/10 

2012-7098 

10/01/2012 
10/30/2012 

FDA/OC/OES/DFOI/ 

NICHAEL  NAZERIAS 
PETNET  SOLUTIONS  INC 

BEAN  APPLICATIONS,  UNIONVILLE,  NY;  MCV  MOLECULAR 
IMAGING  CENTER,  RICHMOND,  VA,  STERLING,  VA,  ETC  - 
483S 

2012-7099 

10/01/2012 
10/30/2012 

OC/COS/OL/ 
OC/OL/ 

MARK  E  GREENWOLD 

CAMPAIGN  FOR  TOBACCO- 
FREE  KIDS 

FAMILY  SMOKING  &  TOBACCO  CONTROL  ACT  OF  2009  - 
CORR  REGULATIONS  OF  NICOTINE  REDUCTION  THERAPY 

Vw/  Vw/  1  1 1  1 ,    II  l_  V_^  VJ  l—l  V  1  1  Vw/  1  V|  \S  Vw /  1       INI  \S  \  '   1   1  1  M  1        1  1 1_  IS  \S  \S  1  1  Vw/  1  VI     III  1  1  1 1  \  1  1 

PRODS  6/22/09  TO  PRESENT 

2012-7100 

10/01/2012 

1  \Jl  \J  1  /  t—\J  1  £— 

10/30/2012 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  \w/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

ROBERT,  THOMAS 

21  USC  321  SECTION  201  CHAPTER  2  DEFINITIONS  I  (G^ 

C—  i    \s  Vw/  Vw/  o  l_  i       i_  v^/  i  i  Vw/ 1  vi  L—  \j  \   \uS  i  i  i\  i     i  i  i  i  £_  iw/ 1_  i   1 1    i  i  i  Vw/ 1    Vw/  i  i  v_^  y 

(CERTIFIED) 

2012-7101 

10/01/2012 
10/30/2012 

FDA/OC/OES/DFOI/ 

GISSENDAMMER,  ROBIN 

483S  -  MOST  RECENT  2012 

2012-7102 

10/01/2012 
10/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Palmer  Lambert 

Gainsburgh  Benjamin  c/o  P. 
Lambert 

BRILLIANT  BLUE  G  COMPOUNDING  AT  FRANCK'S  LAB,  INC 
-  INSPECTIONS,  ENFORCEMENT  RECS,  CONTAMINATED 
LOTS,  ETC 

Page  6  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201 2-71 03 

C—  \J  \  C—     I     \  \J\J 

10/01/2012 
10/30/2012 

OC/OM/OMP/DDM/ 

V  '  V-/,<  Vw/  1 VI/  V_/l  V  1 1    /  L/  [_/  1  VI/ 

JONATHAN  BERMAN 

\J  V_/  1  N I  \  1  1  lr\l  N    !  J  1  i  nvini  N 

JONES  DAY 

DKT  1978N-0038 

l_/  1  V  I      1  \J  I  U  1  N  \J\J\J\J 

2012-7104 

10/02/2012 
10/31/2012 

OC/OM/OMP/DDM/ 

ROSS  RENDELMANN 
HOGAN  LOVELLS  LLP 

DKTFDA-2012-P-1028 

2012-7105 

C—  \J  1  £_     1     1  \J\J 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /%/  Vw/  1 V  1  1      11  \  '  L/  1  1  1/  > — /  III    /  L/  1  L-/  1  / 

Stpnhpn  .Ipnkin^ 

LYBREL - AERS 

1       1  \—J  \   \  \  1            /  \  1  1  l  V/ 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1 V  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Law  office  of  Sybil  Shainwald 

2012-7106 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       1  / 1    \!   Vw/  1 V  1  1          1    /   V  '  L/  1     11      1/   \w/  \w/  1— —  1     1/    1  /  1       Vw/  1/ 

Rphpppa  Shplburnp 
Ellipse  Technologies,  Inc. 

K1 1 1 136 

l  V  I    1    1    1  Ju 

2012-7107 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

i  i — '  /%/  \w/ 1  v  1 1     it  \S  I— /  i  ii  1/  v_/  \w / 1_  i  i/  i  /  i   Vw/  j/ 

Pphpppa  Shplhurnp 
Ellipse  Technologies,  Inc. 

K1 20291 

1  \   1  L—  V/  L—  \J  1 

2012-7108 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /%/  Vw/  1 V  1  1      11  \J  l—s  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

TeraRecon,  Inc. 

K083423 

2012-7109 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \l  Vw/  1 V  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

Rphpppa  Shplhurnp 

I  IvUbvUU  V_J  1  ICIUUI  1  1 

Ellipse  Technologies,  Inc. 

K1 10070 

1  V  I    1  vv  J  v 

2012-7110 

10/02/2012 
10/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Robert  Weissman 

Saretsky  Katz  Dranoff  &  Glass,  LLP 

DMAA  -  INVESTIGATION,  RECS  RE  POTENTIAL  HARM, 
ADVERSE  EVENT  REPORTS,  ETC 

2012-71 1 1 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1 V  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  L/  1  1  /  1  / 

1 —  lou  v/Uui  lui 

VIVITROL  -  REVIEW  PACKAGE  FOR  S01 5 

V  1  V  1  1  1  l  Vw/ 1_        1  1 1_  V  1  1      V  V    1    1  \  \  '  1  V/\  Vwi  1        1    Vw/  1  1    U  \J  1  v/ 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /%/  Vw/  1 V  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

LASamatovicz 

2012-71 12 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /%/  Vw/  1 V  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

Pphpppa  fihplhiirnp 

I  IvUvyvU  V_J  1  ICIUUI  1  1  \j 

Ellipse  Technologies,  Inc. 

K091445 

i            i    i  i  \j 

2012-71 13 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

LAUREN  BARR 

l—l  \  V/  1  1 1— —  1  *l    I—/ 1  \  1  1 1  l 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  8/6-10/12 

1    Vw/  1    L/  /  VI  1       1     L_  Vw/  V^l   V//  \J     IV//    1  L_ 

2012-71 14 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

LISA  TARISON-SCHRAMP 

1  1  VZ 1  \     1  1  \  I  11  \J  Vw/  1  N    V/  V/  1   1  1  1 1  \  \  V  1  1 

CanReg,  Inc. 

FOI  DAILY  LOG  9/10-14/12 

1    Vw/ 1    l_//  V 1  L_  1     1  V_/  V^l    \Ji    1  V/     1     1/    1  L— 

2012-71 15 

10/02/2012 
10/31/2012 

1  \J  1  VJ    1  /  t —  V/    1  L — 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

LISA  TARISON-SCHRAMP 

1  1               1  /  \  1  1 1  \J  Vw/  1  N    V/  Vw/  1   1  1  1 1  \  1  V 1  1 

CanRpn  Inc 

FOI  DAILY  LOG  9/3-7/12 

1    Vw/  1    L/  /  VI  1       1     l_  Vw/  V^l    *_//  *_/     III  L— 

2012-7116 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

FOI  DAILY  LOG  9/10-14/12 

2012-7117 

10/02/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 

FOI  DAILY  LOG  9/3-7/12 

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10/31/2012 

DOMINION  GROUP  INC 

2012-71 18 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

1  1— '  1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

WILLIAM  A  OLSON 

v  v  1 1  i  1 1  v  i  v  i  i  \  Vw/ 1  Vw*  v^/ 1  v 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  9/10-14/12 

1    Vw/ 1    l_//  V 1  L_  1     1  V_/  V_x1    \JI    \  \J     \  *T/    1  L_ 

2012-7119 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

WILLIAM  A  OLSON 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  9/3-7/12 

2012-7120 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  9/10-14/12 

2012-7121 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  9/3-7/12 

2012-7122 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  9/10-14/12 

2012-7123 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  9/3-7/12 

2012-7124 

10/02/2012 

1  \JI  \JL—I  L—\J\S— 

10/31/2012 

FDA/OC/OES/DFOI/ 

1  1— •  i\l  Vw/  Vw//  Vw/  1 —  VJ/        1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  9/10-14/12 

1    Vw/  1  1 — '  1  \  \  L_  1     L_  v_/  V^l    \Jf    1  \J     1  *T/    1  L_ 

2012-7125 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  9/3-7/12 

2012-7126 

10/02/2012 
10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  \J  1— •*  1  1  1/  Vw/  III    /  l_/  1 !_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  1  V/  Vw/ 1 V  1 1      1  /  V/  !_/  1  1  1/  V_/  III    /  [_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Annplia  Rlavtrin 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

DYNAMIT  NOBEL  GMBH  KALKSTRASSE  LEVERKUSEN 

1  •'  1  1  N  f\  1  V  1 1  1     1  M  V/  1  >  \  1       \-A  1 VI 1  1 11,1  \f  VI  1  V  Vw/  1  1  \i  \  Vw/  Vw/  1  ,    1  1       VI  1  11  V  VJ  \J  1  IN, 

GERMANY  -  02/01/12-07/31/12 

2012-7127 

10/02/2012 
10/31/2012 

FDA/OC/OES/DFOI/ 

Christina  Colla 
Christina  Marie  Colla 

PHARMACEUTICAL  COMPANIES  -  VIOLATIONS 

2012-7128 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  /  V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  Vw/  III    /  !_/  1 1  '  1  / 

Mpnrlv  Rnltnn 

ARMOUR  THYROID  -  NONAPPROVAL  DECISION  RECS 

l\  1   1 1  V  1  v  /  ^  /  |  1     1  1   1   1   1  I  V-/  1  !_/        1  N  V/l  "Jr\l     1     1  l  Vw/  V  1  \  \       !_/  1  WlulWIN    1  11  Vw/  VwJ 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Bolton,  Mendy 

2012-7129 

10/02/2012 
10/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Abigail  Ross 

Keller  and  Heckman  LLP 

6/8/78  LTR  FROM  HW  CHAO  TO  WL  SCHLEYER;  5/22/61  LTR 
FROM  FA  CASSIDY  RE  CORROSION  PREVENTATIVE  IN 
WATER;  ETC 

2012-7130 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

David  Lin 

NDA  202736  -  APPROVAL  PACKAGE 

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Subject 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      It  \S  IS  1  1  1/  \-s  III    /  I — f  I  IS  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

BIOLOGICS  CONSULTING 
GROUP 

2012-7131 

10/02/2012 
10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Nicola  Kaiser 

IBL  International  GmbH 

K1 02841 

2012-7132 

10/02/2012 

1  \JI  \j  i—i  t—\J\i— 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \J  \S  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Hamnu^  Rv^tpdt 

1   1  CU  1  1 LJ  O    1  IVOLtUl 

BRANN  AB 

ALTU-237  -  PRODUCT  FILED  BY  ALTUS  PHARM'  ALLN-177 

/  \  I      1  \s    C—  O  /          III  \S  IS  \S  W  1     1     1  1  1  IS    IS  1     /  \  1      1  K-J  \—J    1     1   1 1  \  1   MVI,   1  \  1—  1—  1  *J  tit 

-  PRODUCT  FILED  BY  ALLENA  PHARM 

2012-7133 

10/02/2012 

1  \JI  \j  i—i  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FOSAMAX - AER 

1    \w/  Vw/  /  VI V  1 1  V  /  \        I  \  l_  1  I 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JOHNSON,  CYNTHIA 

2012-7134 

10/02/2012 
10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1   If  W  III    /  L*/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/ 1  v  1 1      11  \  '  Lh'  1  1  1/  > — /  III    /  1 — '  1 1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

THOMAS  DeMELFI  Jr 

1  1   1  Vw /  1  V  1 1 \  \S    IS  \^/  1  V  1  1_  l_  1    1    i_J  1  ■ 

AMGEN 

TOPOMAX  NDA  20-505/S-022  20-844  S-019-APRVL 
MEDICAL  RVW,  CHEMISTRY  RVW 

2012-7135 

10/02/2012 
10/31/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

RICHARD  O.  WOOD 
WOOD  BURDITT  GROUP 

LEESAR  REGIONAL  SERVICE,  FT  MYERS,  FL  -  482,  483 
LAST  5  YRS 

2012-7136 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \J  IS  1  1  1/  \S  III    /  IS  1  L-/  1  / 

DR  HONG  SAJONZ 

IS  11.    II  \S  1  N  \Si    *s  1  \\J  Vw/  1  M  L  

MULTIHANCE  NDA  21 -357/S01 1  NDA  21 -358/S009 

1 V  1  lS  1»_  1  1  1   1 1  \  1  *l  \s  1— —    1  M  IS  1  \  L—  \     \J\J  1  1  *S\J  1    1  *    1  *l  IS  1  \  L_  1     \J\JKJl  *S\J\J  \J 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \S  IS  1  1  1/  W  III    /  \S  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Bayer  HealthCare  Pharmaceuticals 

2012-7137 

10/02/2012 
10/31/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

1    IS  1  \!  \s  \-A  1   I       1    /  \s  1   1  /  \/  W  1— —    1    Vw//  W  1   1  1 

DO/CHI-CB/ 

WILSON,  MELISSA 

.IR  CARLSON  LABS  -  EIR  SUMMARY  SPL  OLJESTIONS  CO 

Ul  1   \S  i  V 1  11  w  W  1  vj    1  1  \  IS  VwJ        1  II  I,    \J  U  1 VI 1  vini  1  1     w  1     1       Vwj<  <S  1  \J  1  IV^/IMW,    *S  Vw/ 

RESP 

2012-7138 

10/02/2012 
10/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

MONTENEGRO,  EBONY 

CMPLNTS  FROM  SALON  WORKERS 

2012-7139 

10/02/2012 
10/31/2012 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

BARRETT  W.  STETSON 

LAW  FIRM  OF  BARRETT  W 
STETSON 

INDIVIDUAL  RECS 

2012-7140 

10/02/2012 
10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHEA  N.  SHAVER 
REILLY  POZNER  LLP 

ZOLOFT  (SERTRALINE  HYDROCHLORIDE)  NDA  19-839  - 
CORR  9/1/05  TO  PRESENT 

Page  9  of  895 


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Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7141 

10/02/2012 

FDA/OF/CFSAN/OCD/EOS/ 

DANIEL  A.  EDELMAN 

LANCOME  USA,  L'OREAL  -  CO  RESP,  CORR,  EFFICACY 

10/31/2012 

EDELMAN  COMBS  LATTURNER 
ET  AL 

9/7/12 

2012-7142 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ALLEN  D.  NICKOL 

NOLVADEX  NDA  17-970/S000  -  APRVL 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ACTELION  CLINICAL  RESEARCH 
INC 

2012-7143 

10/02/2012 
11/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

OC/COS/OES/ 

OC/COS/OES/ 

OC/COS/OL/ 

OM/OMP/DODM/ 

THOMAS  P.  KELLY 

LAW  OFFICES  OF  PETER  G 
ANGELOS 

COLGATE  PALMOLIVE  CO  -  REGULATIONS,  GUIDELINES, 
VIOLATIONS  REGARDING  COSMETIC  TALCUM  POWDER 
PRODS,  ETC 

2012-7144 

10/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

NOVARTIS  -  METHERGINE  WARNING  LABEL 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHAW,  CARISSA 

2012-7145 

10/03/2012 
11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

FDA/OGROP/ORA/ORO/DIOP/ 

CARL  R  NIELSEN 

C  NIELSEN  CONSULTING  LLC 

NANTONG  TIANLONG  ANIMAL  BY-PRODUCTS  CO  LTD, 
JIANGSU,  CHINA  -  EIRS,  ANALYTICAL  RPTS,  CMPLNTS,  ETC 

2012-7146 

10/03/2012 
11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UMr  I  /OUbn/Unr/UIIJr/ 
rUM/UIVIr  I  /uUtn/Unr/UlUr/ 

JASON  G  SHEASBY 
IRELL&  MANELLA  LLP 

SEATTLE  GENETICS  -  ADCETRIS  (BRENTUXIMAB  VEDOTIN) 
NON-CLNCL  PHARMACOLOGY,  TOXICOLOGY,  HUMAN 
PHARMACOKINETICS,  ETC 

2012-7147 

10/03/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ROBERT  J  KING  JR 

ABBOTT  LABS  -  CMPLNTS,  INSPS,  ETC;  INDIVIDUAL  RECS 

11/01/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OGROP/ORA/CE-FO/DET- 
DO/DET-CB/ 

LOMMEN  ABDO  COLE  KING 
STAGEBERG  PA 

2012-7148 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

MCKENZIE  CATO 

OFFICE  OF  GENERIC  DRUGS  -  180-DAY  EXCLUSIVITY 

Page  1 0  of  895 


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Subject 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Hyman,  Phelps  &  McNamara,  P.C. 

2000-2012 

2012-7149 

10/03/2012 
11/01/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OC/OES/DFOI/ 

ELENA  HOWELL 
HOGAN  LOVELLS  US  LLP 

BRINKHOFF  &  MONOSON  INC  -  ARCHER  FARMS  BRAND 
GROUND  TURMERIC  RECALL  LOTS  1740901A,  2180902A, 
2780906A,  ETC 

2012-7150 

10/03/2012 
11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

MARCIA  L  BENEDICT 
STERIS  CORP 

STERRAD  NX  DUO  CYCLE  TEST  PACK  K1 1 1391 ;  STERRAD 
CYCLESURE  24  BIOLOGICAL  INDICATOR  K1 1 1375; 
STERRAD  1 00NX  STERILIZER  DUO  CYCLE  K1 1 1 3777,  ETC 

2012-7151 

10/03/2012 

1  \JI  \J\JI  C—\J\L— 

FDA/OGROP/ORA/SE-FO/SJN- 

1  1 — /  1  \!  \w/  > — A  1  I  \S  1    /  \w/  1   It  \/  \J  l__    1    \SI  \J\J  1  >l 

TYLER  KENYON 

1     1   1  l__  1   l    1  V  1  1  N   1  Vw/ 1  N 

ZIMMER  HOLDING  PONCE  PR  -  WARNING  LTR  9/21/1 2 

L  1  I  V  1  1  V  I  1  1  1    1   1  \s  1—  IS  1  1  M  V_H  ,    1     Vw/ 1  *J  V/  1— —  ,111         V  V  /  \  1   11  N  1  M  Vwi    L  1  1  I   \JI  C—  \  1    \  C— 

11/01/2012 

DO/SJN-CB/ 

NORTHCOAST  RESEARCH 

2012-7152 

10/03/2012 
11/01/2012 

FDA/OF/CFSAN/OCD/EOS/ 

DR  PETER  D  FOSTER 
HUHTAMAKI  INC 

JOHNSON  POLYMERS  -  STYRENE-ACRYLIC  COPOLYMERS 
FCN  130,  FCN  231 

2012-7153 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      11  \J  L/  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

Rarhpl  Johnson 

1   ICIV-'I  1  v/ 1   i_/ k/ 1  II  IOUI  1 

BLA  103772/S51 13 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \  '  IS  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7154 

10/03/2012 
11/01/2012 

OC/OOPD/ 

Daven  Mody 

Impax  Laboratories,  Inc. 

NEURONEX  INTRANASAL  DIAZEPAM  -  ORPHAN  DRUG 
DESIGNATION  RECS 

2012-7155 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

Rophpi  .Inhn^on 

1  ldv.fl  lul   Uvl  II  IOv/1  1 

NDA20281 1 

1  ML//  \L—  V/  C—  V/  1  1 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  (_/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7156 

10/03/2012 
11/01/2012 

OC/OOPD/ 

V-/  V//  Vw/  Vw/  1     L/  / 

FDA/OMPT/OSMP/OOPD/ 

Davpn  Modv 

is v  v>  i  i  iviv/v/y 

Impax  Laboratories,  Inc. 

BOTOX  BENEFIX  GRALISE  ETC  -  ORPHAN  DRUG 

IS  Vw/  1  \s  /  \  ,    IS  1  1  M  1  1     1  /\  ,    V_/  1  1 1  \  1—  1  V/  1  ,    1       1  V/        Vw/  III     II I  \  1  N    \S  1  I  kw/  V_/ 

DESIGNATION/EXCLUSIVITY  RECS 

2012-7157 

10/03/2012 

1  \Jl  \J\J/  C—\J\L— 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  l — '  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

Annp  Mitrhpll 

i  \  1  II  1  \/   IVIILvyl  lull 

Mitchell,  Anne 

RENAL  SHOCKWAVE  LITHOSTRIPSY  -  ADVERSE  EVENTS 

1  1 1  1  *J  /  \  1       v_/  1   1  V-/  V/  1  V  V  V  /  \  V  1        L- 1  1  1   1  \_/U  1  1  1 1  1     V/  1         V  \  t — '  v  1  1   I  \S  1        l_  V  1— —  1  >l  1  \—J 

2012-7158 

10/03/2012 
11/01/2012 

FDA/OC/OES/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

FOIA  LOG  07/01/2012  to  09/30/2012 

1    v/  1  /»   I—  Vw/         V/  /  /V/  1  /  l—  \J  1  £ —    LV/   \J  \JI  V/  v//  l —  \_/  1  £_ 

2012-7159 

10/03/2012 
11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Louise  Miller 
LRT  Trading 

STATENS  SERUM  INSTITUT,  COPENHAGEN,  DENMARK - 
INSPECTION  RECS,  RECALLS,  CONSENT  DECREE  ETC 

Page  1 1  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


\_/UI  III Ul  tt 

Due  Date 

MO  LIU  1 1  WIMOU 

oILJMalUit!/  nc^Uuolcl 

OUUJtfOl 

{—  r-\  n  is~\  f,  irt  //""N  r~s  | —  r—\  is-\  nn/r\inn/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7160 

10/03/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Angelia  Slayton 

PFIZER,  GROTON,  CT  -  EIR,  493,  CORR  05/04/09 

11/01/2012 

DO/NWE-CB/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-7161 

L_ \J   1  L—     1     1  \J  1 

10/03/2012 
11/01/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

FOI  DAILY  LOG  9/17-21/2012 

1    Vw/  1  1— /  /  VI  1       1     L_  Vw/  V^l      \J/    11     L—  1  /  £_  V/  1  L— 

2012-7162 

10/03/2012 
12/14/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Richard  Hpnrirh 

1  l  \\j  1  1  Cll  \A    1   1 W  1  II  IUI  1 

Chemtura  Corporation 

FCN  1 152 

1    V/  IN     II  v/  L_ 

2012-7163 

10/03/2012 
11/01/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Avery  Hartley 
Avery  Hartley 

AQUAFINCA  ST  PETER  FISH,  HONDURAS  -  COMPLAINTS, 
INSPECTION  REPORTS 

2012-7164 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  \  '  lw/  1  1  1/  > — /  III    /  1 — '  1  !_/  1  / 

1  inda  Mnta 

BLA  103772  S51 1 3' NDA  22000  S005' NDA  20281 1 

1  '  I—/ \      1  UU  I    /  L—  »    O \J  1     1  \-f  ,    1*1  I—/  I  \    L—  LUUU.    Vw/  V/  V/       .    1  VI  1_/  /  \    £_  V/  L_  W   1  1 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Shire  Development  LLC 

2012-7165 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  Vw/  III    /  l_/  1  i  /  1  / 

AMERICAN  HOME  PRODUCTS  -  WARNING  LETTER  02/14/92 

l  \  1  V  1  l_  1  11  Vw / 1  \  \  v    |   |  Vw/  1  v  1  1        1     11  Vw/  1—/  Vw/  V_/  1  V/         V  V  /  V 1  1 1  V|  1  1  V  Vw4    1—  1— —  1    1  1  1  I   \j  L—l    1         v/  L_ 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  1— /  1  1  1/  V_/  III    /  (_/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

HOLLINGSWORTHLLP 

2012-7166 

1  C    1    1  WW 

10/03/2012 
11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  \  '  Lp/  1  11   1/  V_/  Vw /  l_  1  1/  1 — /  1    Vw/  1/ 

COVIDIEN 

K1 20657 

2012-7167 

10/03/2012 
11/01/2012 

FDA/OC/OES/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

2012-6560 

2012-7168 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  '  /    V/   Vw/  1  V  1  1          1    /  Vw /  1— /  1         |     1/   V_/  III       /    I  '  |  1— /  |  / 

Sharon  Mvpr^ 

ADENOSCAN - SBA 

/\  L-/ 1  i  iiwvjv/rvi  >i  uun 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  AND  COMPANY  - 
PHARMACEUTICAL  DIVISION 

2012-7169 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Kim  Wag  nor 

NDA  20281 1  -  REVIEWER  REPORTS 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BIOPHARM  DEVELOPMENT 
ASSOCIATES,  LLC 

Page  1 2  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7170 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

Sharon  Mvpr^ 

ADENOCARD  IV  -  SBA 

nui  i  *j  Vw/  \j  i  \  i  tL/  i  v      \wJ  i  it  \ 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  AND  COMPANY  - 
PHARMACEUTICAL  DIVISION 

2012-7171 

10/03/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

PFIZER,  GROTON,  CT  -  EIR,  483,  CORR  10/14/10 

11/01/2012 

DO/NWE-CB/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-7172 

10/03/2012 
11/01/2012 

FDA/OC/OES/DFOI/ 

1  1— '*V  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    VwX  1/ 

Joan  Stitt  (UG2CD-16} 

1   WLIIL    IUV<luV/L/     1  \J  J 

MERCK  &  CO.,  INC. 

FOIA  REQUESTS  CLOSED  9/1/12-9/30/2012 

1     Vw/  1 1  \    1    l  1  VwX  KJ  1  V/   1  Vw/  Vw /  L_  Vw/  V_/  1   1 — /     \Jf    \  1    1  L—     \J  1  \J\JI  L—  \J  1  C— 

2012-7173 

10/03/2012 
11/01/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt(UG2CD-16) 
MERCK  &  CO.,  INC. 

FOI  DAILY  LOG  9/24-28/2012 

2012-7174 

10/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L*s  1  1  1/  V_/  III    /  L/  1  1  /  1  / 

Rarhpl  Johnson 

1   ICl.V-'l  1  \/ 1   \j  k/  1  II  IOUI  1 

NDA  22000/S5 

1  *J  (_/  /    V     L  L_  W  V/  W  ^J\J 

11/01/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  > — /  III    /  1 — '  1  !_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7175 

10/04/2012 

1  \JI  KJtf  t—\J\l— 

11/02/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

1  1 — '  1  \!  Vw/        1  1  V_/  1    /  Vw/  1  1/  V/  v^/  l_    1    Vw//  1    I—/ V 

DO/FLA-CB/ 

Richard  O  Wood 

1   ilul  1  CI  1  \A    Vw/  ■    V  V  vvU 

WOOD  BURDITT  GROUP 

FLORIDA  BIOLOGIX  ALUCHUA  FL  -  482  483  CORR  ETC 

1    l_  V^/  1  1 1  L*s  / \    1  '  1  Vw /  L_  Vw /  V_-4  l/^i    /  V i_  Vw^  U  1   1  KJ i  \  1    1    1—            V/ L_  ,                 j    V/  Vw/  1  1 1  1    1       1  \J 

2012-7176 

10/04/2012 
11/02/2012 

FDA/OC/OES/DFOI/ 

Dr.  Shiels  /  Amanda  Bundy 
Children's  Radiological  Institute 

FDA  DRUG  BULLETIN  FDA  JULY  1 989;1 5-1 6 

2012-7177 

10/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L*s  1  1  1/  V_/  III    /  lw/  1  L/  1  / 

DAVID  PULLMAN 

1  J 1  \  V  1  1  /    1     U  1  1  1  V  1 1  \  1  il 

STATINS  -  AERS 

\j  1  l  \  1  1 1  >i          I  \  l— _  i  i  \wJ 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Pullman,  David 

2012-7178 

10/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

Annplia  Slav/ton 

ni  ly \d 1 1 ci  vj icty  i v/ 1  i 

BLA  125360  S007 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  Vw/  III    /  l_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-7179 

10/04/2012 
11/02/2012 

FDA/OMPT/CTP/OD/ 

KEVIN  ALDRIDGE 
Aldridge,  Kevin 

LIST  OF  APPROVED  CIGARETTE  TUBE  MANUFACTURERS 
FOR  RYO 

2012-7180 

C—  \J  1  £_     1     1  \J\J 

10/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    \—s  1  \!  Vw/  1  v  1  1      1  /  VwS  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

1  aura  F  Hron 

LQUI  CI    1    .111  \J\  1 

EPOGEN/PROCRIT  -  APPROVAL  LETTER 

1  1     Vw/  Vw4  1— —  1  M/  1     1  I  Vw/  V/  1  1 1  1         V  \  1     1     1  I  Vw/  V  /  V 1       1  l_  1    1  l_  1  1 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Office  of  Joel  M.  Fineberg 

Page  13  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 


Total  Records:  9990 


Control  # 


Reed  Date  / 
Due  Date 


Action  Office 


Signature/  Requester 


Subject 


2012-7181 


2012-7182 


10/04/2012 
11/02/2012 

10/04/2012 
11/02/2012 


FDA/OMPT/CDRH/OCER/DFOI/ 
OC/COS/OES/ 

OC/COS/OES/  

FDA/OF/CFSAN/OCD/EOS/ 


Tom  Burton 

THE  WALL  STREET  JOURNAL 

Elizabeth  Metcalf 

Morgan  &  Morgan,  P.C.  


REPORT  FOR  OFFICE  OF  SPECIAL  COUNSEL  RE  SAFETY 
OF  MEDICAL  DEVICES  INCLUDING  COLONAGRAPHY 


SUAVE  PROFESSIONALS  KERATIN  INFUSION  KIT  - 
COMPLAINTS,  COMMUNICATIONS  WITH  UNILEVER 


2012-7183 


2012-7184 


10/04/2012 
11/02/2012 


10/04/2012 
11/02/2012 


FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/  

FDA/OMPT/CDRH/OCER/DFOI/ 


ISIS  SERVICES,  SAN  CARLOS,  CA  -  EIR  03/22/1 1 -04/07/1 1 


The  Windward  Company 


Beverly  Morrison 
Morrison,  Beverly 


K061011 


2012-7185       10/04/2012  ORA/ 

11/02/2012  ORA/ 

FDA/OGROP/ORA/PA-FO/SEA- 
 DO/SEA-CB/  

2012-7186       10/04/2012  FDA/OMPT/CDER/ORP/DIDP/ 
1 1/02/2012  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

 FDA/OMPT/CDER/ORP/DIDP/ 

2012-7187       10/04/2012  FDA/OMPT/CDER/ORP/DIDP/ 
1 1/02/2012  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

 FDA/OMPT/CDER/ORP/DIDP/ 

2012-7188       10/04/2012  FDA/OGROP/ORA/CE-FO/CHI- 
11/02/2012  DO/CHI-CB/ 


Robert  McLennan 
Oregon  Heritage  Farms 


Kimberly  Calandriello 


SAMPLE  770367  -  ANALYTICAL  RESULTS 


VENLAFAXINE  ER,  EFFEXOR  XR  -  AERS 


CenterWatch  Monthly 


Richard  O.  Wood 
WOOD  BURDITT  GROUP 


NUMBER  OF  CLINICAL  HOLDS  APPLIED  TO  CLINICAL 
RESEARCH  STUDY  OR  NEW  DRUG  APPLICATION  DUE  TO 
MISLEADING  OR  INCOMPLETE  INVESTIGATOR  BROCHURE 


ORGAN  RECOVERY  SYSTEMS,  ITASCA,  IL  -  INSPECTION 
RECS 


2012-7189 


10/04/2012 
11/02/2012 


CVM/OCD/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


Horace  Nalle 

Oriole  Animal  Health  LLC 


STUDIES  OF  SAFETY  OR  EFFICACY  OF  IBUPROFEN  AND 
FAMOTIDINE  IN  DOGS 


2012-7190 

10/04/2012 
11/02/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

Avery  Hartley 
Avery  Hartley 

TRIDENT  SEAFOODS  CORP  -  TEST  RESULTS  2005  TO 
PRESENT 

2012-7191 

10/04/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

NIDIA  NOEL 

ABBOTT  LABS,  NORTH  CHICAGO,  IL  -  EIR  MOST  RECENT 

Page  14  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 


Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/02/2012 

DO/CHI-CB/ 

EZEM  CANADA 

2012-7192 

10/04/2012 
11/02/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

janet  a.  Mccormick 

interior  alaska  fish 
processors  inc 

\/i  i \s t~\ k\  nn  /i —  n  /™» n\    i/  a  i  t  a  ^    a  i/     rm  Ar\A7  -r/~\  or^ h  a 

YUKON  RIVER  GOLD,  KALTAG,  AK  -  EIR  2007  TO  2010 

2012-7193 

10/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

BRITTANY  LaPOINTE 

1  f  1  l  1  1    1  t  \  \  X  1     L_CA  1     Vw/  1  1  N  1  1— — 

ZOLOFT  - APRVL 

£.  Vw/  l_\w/  1      1         1  \  1     1  I  V  L 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DISCOVERY  RESOURCE 
LITIGATION  SUPPORT  SERVICES 

2012-7194 


2012-7195 


2012-7196 


2012-7197 


10/04/2012 
11/02/2012 


10/04/2012 
11/02/2012 


10/04/2012 
11/02/2012 

10/05/2012 
11/05/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

OC/OCC/ 

OM/OMP/DODM/  

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

ORA/OCI/ 

OC/OCC/  

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OF/CFSAN/OCD/EOS/ 


JAMES  R.M.  HEMMINGS 
SIDLEY  AUSTIN  LLP 


DKTS  2007P-0358/CPI;  FDA-2007-P-01 1 1 ;  2007D-0168 


WHITE,  ROBERT  W 


PAXIL,  DEPAKOTE,  WELBUTRIN  -  OFF-LABEL 
PROMOTIONS,  INVESTIGATION  RECS  REGARDING 
CHILDREN,  TEENS,  ETC 


ALISON  M.  AGNEW 

PILLSBURY  WINTHROP  SHAW 
PITTMAN  LLP  

Becky  Cooseman 

Brown  &  Crouppen,  PC 


INSULET  CORP  -  OMNIPOD  SINCE  2009 


INDIVIDUAL  RECS 


2012-7198 


10/05/2012 
11/05/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OO/ 


INDIVIDUAL  RECS 


Doe  J 


Page  15  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OO/OHR/ 

2012-7199 

10/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Robert  E.  Shapiro,  MD,  PhD 

ISRS  45767436,  4621 628X,  65601858,  65985025 

11/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  VERMONT 

2012-7200 

10/05/2012 
11/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Yves  Arramon 
SpinalMotion 

K1 10632 

2012-7201 

10/05/2012 
11/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Shawn  Esmaili 
Cercacor  Labs 

K1 12638 

2012-7202 

10/05/2012 
11/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Yves  Arramon 
SpinalMotion 

K1 12036 

2012-7203 

10/05/2012 
11/05/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

GE  HEALTHCARE,  SOUTH  PLAINFIELD,  NJ 
3/10/11 

-  EIRs  5/10/10, 

2012-7204 

10/05/2012 
11/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Kerry  King 
Intertox,  Inc. 

K932868 

2012-7205 

10/05/2012 
11/05/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

BRACCO  DIAGNOSTICS,  PRINCETON,  NJ  - 
7/12 

EIRs,  483s  3/11, 

2012-7206 

10/05/2012 
11/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Alison  Stuebe 

UNC  School  of  Medicine 

METHERGINE  -  AERS 

2012-7207 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-6487 

2012-7208 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-6270 

2012-7209 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-5921 

2012-7210 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-5686 

2012-7211 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-5601 

2012-7212 

10/05/2012 
11/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

2012-5604 

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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

201 2-721'? 

10/05/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

l_/ 1  \  V  1  L-/    IVIWI    rvi  1 1  I  \  \  H  LS 

201 2-5r?07 

t—  VJ  1        v/v/*J  / 

11/05/2012 

FDA  WEBVIEW/FERDIC  INC 

2012-7214 

10/05/2012 

1  \Jl  W\JI  t—\J  1  C— 

FDA/OC/OES/DFOI/ 

1  I— '*V    Vw/  Vw//   Vw/  |         Vj/  1— /  |       VwX  1/ 

DAVID  MCFARLAND 

1  J 1  \  V  1  1 — /    1  v  1  Vm/  1    i  V 1  1 1—/  \  1  *l  1 — / 

2012-3134 

11/05/2012 

FDA  WEBVIEW/FERDIC  INC 

2012-7215 

10/05/2012 

1  \Jl  \J\Jl  L—\J\S— 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J  1  \  V  1  1  /    1  v  1  Vw /  1    V  \  1  1 1  I  \  1  N  1 — / 

2012-6515 

11/05/2012 

FDA  WEBVIEW/FERDIC  INC 

2012-7216 

10/05/2012 

FDA/OC/OES/DFOI/ 

1  l— '*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  /  /  \  V  1  1  /    1  v  1 V/  1    /  x  1  1 1  1  \  \  *l  1 — / 

2012-6271 

£_  V/  1  L_    V/ 1_  /  1 

11/05/2012 

FDA  WEBVIEW/FERDIC  INC 

2£>\2.-12\l 

10/05/2012 

1  \Jl  \J\Jl  L—\J\S— 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J  1  \  V  1  1  /    1  v  1  Vw /  1    /  \  1  1 1  /  \  1  *l  1 — / 

2012-4694 

1  1  I\J\JI  C\J  \  (— 

FDA  WFRVIFW/FFRDIP,  INP, 

1    L/ /  \  V  V  1  l_)  V  II  V  V  /  1    1  1  I VJ  1  V_/  1 1  >l\_/ 

2012-7218 

10/05/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J 1  \  V  1  1  /    1  v  1  Vw y  1    V  \  1  1 1  1  \  \  >l  1 — / 

2012-5841 

L_  V/  1  £_    ^/  V/   l  1 

11/05/2012 

FDA  WEBVIEW/FERDIC  INC 

2012-7219 

10/05/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

1  1— '  /  V/  Vw/        1  1  Vw/  1    /  Vw/  1  It  \I        V  V     1    V_//  L-//  \  1  

JOHN  WALSH 

\J  Vw/  1     1  1  N      V  V  /    \  1  K-J  1  1 

CARE  FUSION  EL  PASO  TX  -  EIRS  483S  RECALLS  10/10 

Vw/  /  \  1  1 1        1    V/  K-f  1  Vw/  1  >J  ,    1  1       1    1  \  Vw /  ,     1  /  V        l__  III  K-J  ,      l  V/  w  Vw/  .    1  1  1  V  '  I  \  \  1  \_)     IV//  IV/ 

1  1  /  UJ/  C\J  \  C- 

DO/DAL-CB/ 

lAMF'1?  Al  FXANDFR  HDRP 

U f\  1 V 1 1  O  /  \ l_  1  /\/\  1  >J l_/  1  1  l  V_/ Vw/  1  1 1 

TO  PRESENT 

2012-7220 

10/05/2012 

FDA/OC/OES/DFOI/ 

ROBERTA  DORMER 

2012-5550,  2012-5647,  2012-6560,  ETC 

11/05/2012 

Hyman  Phelps  and  McNamara  PC 

2012-7221 

10/05/2012 

F  D  A/0  F/C  FS  AN/OC  D/EOS/ 

WILBUR  JOHNSON  JR 

METHYL  GLUCOSIDE  COCONUT  OIL  ESTER  (METHYL 

11/05/2012 

COSMETIC  INGEDIENT  REVIEW 

GLUOCSDE  SEQUICOCOATE)  -  CHEMICAL  &  PHYSICAL 

PROPERTIES,  METABOLISM/BIOAVL,  DERMAL 

n i —  k  1 1 — r n  a  tian  i  i — r/^> 

PENETRATION,  ETC 

/-\ /~i  -<  n  loon 

2012-7222 

■i  f\  /A C  /A  A  4  A 

10/05/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

a  mm  i/  nn — r i —  n 

ANN  K  RITTER 

AkJirni  o     i  i  n  /~» r~  ni —  n     r~  pv  i      /-v  n  n  i —  i       \  / 1  /-\  i   a  tian  i  /~\  r-  rnA 

AMERISOURCE  BERGEN  CORP,  FL  -  VIOLATION  OF  FDA 

■i  H  /A C  /A  A  4  A 

1 1/05/2012 

DO/FLA-CB/ 

^  a  /^\~ri  i —  v/  n  i  /~>  i —  i  ■  /~» 

MOTLEY  RICE  LLC 

AMENDMENTS  ACT  OF  2007  ;  BELLCO  DRUG  CORP 

FDA/OMPT/CDER/ORP/DIDP/ 

(AMERISOURCE  BERGEN  CORP)  2008  -  EIRS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      11  V/  L- /  1  1  1/  V^/  III    /  ( — /  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

Vw/  1  1  / V  Vw/  V_/  1  / 

ORA/OCI/ 

Vw/  1  1  / V  Vw/  \_»  1  / 

?D1  2-72P3 

FnA/DF/r.FSAN/nnn/Fnc!/ 

i  \—Jt\i  v_y  n/  o  i  o/\  i  \i/  v_/\_/ 1—// 1  v_/o/ 

lAMF'1?  H  HARTTFN 

U  r\  1 V 1  1  O  1  1    1  1  r\  \  1  1    1  1  1  NJ 

1  ANHDMF  1  ISA  -  RFSP  TD  WARNING  1  TR  P/7/1  ? 

N  v/  V_/  IV 1 1      \J  0/\       111  0 1       1  V_/  V  VfMll  N  1 1  N  V_J  1     1  n  •Jill  \  C 

■4  A  lf\E  /A  A  A  A 

1 1/05/2012 

a  ni —  n i ~r  i — /~\ v/  i  i  o 

ARENT  FOX  LLP 

2012-7224 

■i  A  /A C  /A  A  4  A 

10/05/2012 

FDA/OGiROP/ORA/PA-FO/LOS- 

nAn  ini  \a/im  /~>  i  ii —  o  ~ri —  n 

ROBIN  WINCHESTER 

f~\  1  ■  i —  pTOAn  n  i  i  AnnyiA^i  \~r\t~*  a  i  o  i  k  i        un  a     ~v  i  i  a  n  i —  i 

QUESTCOR  PHARMACUTICALS  INC  -  HP  ACTHAR  GEL 

11/05/2012 

DO/LOS-CB/ 

KESSLERTOPAZ 

EIRS,  WARNING  LTRS,  APRVL,  ETC 

FDA/OMPT/CDER/ORP/DIDP/ 

MELTZERCHECK  LLP 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

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Total  Records:  9990 


Pnntrnl  if 

nfciOU  L/dLc  / 

HO  HUM  wlllOc 

oiyiidLure/  rietjUebLci 

ouujeoL 

Due  Date 

FDA/OMPT/nnFR/nRP/DIDP/ 
r  \—jf\/  v_/ivi  r  i  /  \_/ 1_/  r__  n/  v_/ 1 1 1  / 1_/ 1  vj  i  i 

OC/OOPD/ 

r~ p\  a  if-\r>  /Are  /nvc/^M  / 

rUA/CJO/Utb/UrUI/ 

FDA/OGROP/ORA/PA-FO/SAN- 

DO/SAN-CB/ 

2012-7225 

10/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L-/  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

Pam  Rrpnnan 

1     CX  1  1  1    1  J 1  V^  1  1 1  1  C4  1  1 

METHERGINE  -  AERS 

1 V  1  1       1  1   1  1  1  I        1  1  N  1            1  \  l—  1  I 

11/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Pam  Brennan 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \J  L/  1  1  1/  W  III    /  [_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7226 

10/09/2012 

1  \Jl  \J\JI  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L-/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

Jaw  ftiroi^ 

ACETAMINOPHEN  -  MEDWATCH  REPORTS 

/  V  Vw/  1       1  /  VI V  1  1  1  *J  Vw/  1     1   1  1  1  M         1 V 1  1— —  L/  V  V  /  \  1  Vw/  1   1    1  1  1  1     Vw/  1  1  1  V/ 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CONSUMER  HEALTHCARE 

FDA/OMPT/CDER/ORP/DIDP/ 

PRODUCTS  ASSOCIATION 

FDA/OMPT/CDER/ORP/DIDP/ 

1    I  /  / V/  Vw/ 1 V  1 1      11  \J  1—/  1  1  1/  V_/  III    /  [_/  1  L/  1  / 

2012-7227 

10/09/2012 

ORA/ 

Nicole  Palen 

OAimi  r~  ni —  o i  ii  ~ro 

SAMPLE  RESULTS 

11/06/2012 

ORA/ 

EMSL  Analytical,  Inc. 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

rUA/UuRUr/UHA/faW-rU/KAN- 

L/  v_//           >l  v/  L_)/ 

F  D  A/0  F/C  FS  AN/OC  D/EOS/ 

2012-7228 

10/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Merle  Zimmermann 

DIETARY  SUPPLEMENTS  -  CAERS  07/01/2011  -  08/31/2012 

1 1/06/2012 

AMERICAN  HERBAL  PRODUCTS 

ASSOCIATION 

2012-7229 

10/09/2012 

1  \JI  \J\J/  L—\J\S— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  V/  L/  1  1  1/  \w/  III    /  1 — '  1  l_/  1  / 

Rarrv  Wpathpr^ 

ljui  i  y   v  »  can  iui  o 

DEPO  MEDROL  -  COMPLAINTS  CORR  AERS  ETC 

Ly  1  1     Vw/    1  V 1  1  Ly  1  1  Vw/  1            V/  Vw/  1  V 1  1     l_  /  \  1 1  i|  1  Vw/  j    Vw/  Vw/  1  11  I  ^    /  V 1  1  I V/  j    1       1  Vw/ 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Barry  E.  Weathers 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L*S  1  1  1/  V_/  III    /  I — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V/  III    /  1— r  1  1— <  1  / 

2012-7230 

10/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  11   1  /  V  /  V  /  1  1  \l  LJ  \  v_/l/ 

I— ii  I \JCX  [\di  ly  a 

K071969 

/  1  cue 

1 1/06/2012 

Nihon  Kohden  America,  Inc. 

2012-7231 

10/09/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

DeAnne  Brooks 

AMERIDOSE,  WESTBOROUGH,  MA  -  MOST  RECENT  EIR, 

1 1/06/2012 

DO/NWE-CB/ 

-p i  ii —  ■  n^\c* i —  o  i  i    a/*\i  i r—  k  * ^ n  a /~\ n ■  «  i 

THE  MOSES  H.  CONE  MEMORIAL 

483 

ORA/ 

HOSPITAL 

ORA/ 

2012-7232 

10/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Donald  Ecklund 

LANCOME,  L'OREAL  -  RESPONSE  TO  WL  ISSUED  9/7/2012 

11/06/2012 

CARELLA  BYRNE  BAIN  ET  AL 

Page  18  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201 2-72'3  3 

10/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

K060656 

11/06/2012 

FDA/OC/OES/DFOI/ 

CBC  Inc 

2012-7234 

10/09/2012 
11/06/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Kathy  Simpson 
Celleration,  Inc. 

K1 12782 

2012-7235 

10/09/2012 
11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Irina  Rivkind 

Irina  Rivkind/Cantor  Fitzgerald 

JAZZ  PHARMACEUTICALS  -  RESPONSE  TO  WARNING 
LETTER  ISSUED  10/11/11 

2012-7236 

10/09/2012 
11/06/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Matt  Zepnick 

The  Edelsteins,  Faegenburg  & 
Brown,  LLP 

TRANS1  AXIALIF  2L  ANTERIOR  SPINAL  FIXATION  MODEL 
NUMBER  TR1 -231 6,  EVENT  DATE:  2/8/10;  TRANS1  AXIALIF 
2L  ANTERIOR  SPINAL  FIXATION  MODEL  NUMBER  TR1-2305, 
EVENT  DATE:  11/23/09  -  MAUDE  REPORTS 

2012-7237 

10/09/2012 

1  \JI  \J\JI  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  / 1    \!   Vw/  1  v  1  1          If    \  '  Lh'  1  1     1/   \w/  III       /    1  f  1  1  /  1  / 

Jim  Pparp 

u  1 1 1 1  i   \j  a  *_< \j 

DHEA - AERS 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Peace,  Jim 

2012-7238 

10/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

STACI  M  TROLIAN 

DR  STEVEN  MARK  TRAINA  -  WARNING  LTR  CORR 

11/06/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

BIOMET  INC 

2012-7239 

10/09/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

DENISE  RIEKER 

VAERS  -  INDIVIDUAL  RECS 

11/06/2012 

ALFB/ 

SANOFI  PASTEUR 

2012-7240 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

CAERS  155912 

2012-7241 

10/09/2012 
11/06/2012 

ORA/ORM/ 
ORA/ORM/ 

JOHNATHAN  RICKMAN 

\J  V**/  1   tl\  /  \  1  1   1 1  \  1  N    III  \-J  1  \  1  v  l/\l  N 

FDA  NEWS 

PHARMACEUTICAL  BIOLOGICS  MEDICAL  DVC  MFG  CLNCL 

1     1   li  VI  1 1 V  \I\\-J  1— —  K-/  \   \  Nw/  /  V  1_  .  1 — 1  1  Vw/  L_  Vw/  \_A  \  \-S \J  .    1  V 1  1  1 — /  1  \—t  1  \  \   1 — ^  V  Vw/    1  V 1  1    \—A  ,    \-/  l_  1  >l  V/  l_ 

FACILITIES  IN  AND  OUTSIDE  THE  US  -  483S  9/1-30/12 

2012-7242 

10/09/2012 
11/06/2012 

OM/OMP/DODM/ 

MELISSA  CERASO 
INFOTRIEVE  INC 

ANTIVIRAL  A/C  MTG  -  FIAU  TOXICITY  TRANS 

2012-7243 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/OIP/ 

SHERRIE  A  IRELAND 
FLASTER  GREENBERG 

FATTORIE  CHIARAPPA  SRL  -  FRESCOLINA  SALATA 
CHEESE  LISTERIA  OUTBREAK  RECALL  RECS,  TESTING, 
CORR,  ETC 

Page  1 9  of  895 


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Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Pnntrnl  if 

rit?OU  Udlc  / 

Due  Date 

HO  HUM  UIIIOc 

OlyildLUlu/  r\t3L]UubLcr 

O  i  1 i  Q/"»t 
OUUjfcJOl 

ORA/ 

ORA/ 

FDA/OC/OES/DFOI/ 

ORA/ORO/DFS/ 

ORA/ORO/DFS/ 

2012-7244 

10/09/2012 
11/15/2012 

FDA/OC/OES/DFOI/ 

ROABERT  P  CHARROW 
GREENBERG  TRAURIG  LLP 

MEDTRONIC  XOMED  INC  -  LASER-SHIELD  II 
ENDOTRACHEAL  TUBE;  LASER  ENGINEERING  INC  -  ULTRA 
MD  40  LASER  SYS  RECS 

2012-7245 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CARLA  R  SCARMAZZI 
KING  &  SPALDING 

CITREM  (CITRIC  ACID  ASTERS  OF  MONO-  AND 
DIGLYCERIDES),  MAGNESIUM  L-ASPARTATE  -  RECS 

2012-7246 

10/09/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  V  '  L_/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

CHI  WAI  NG 

\  '  III    V  V  t  \  1    1  N  \s 

METHOXYFLURANE  -  AERS 

1 V  1  1       1  1   1       /\  1   1    1  *S  1  1 1  \  1  VI  l_        1  \  1  1  Ws 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \-S  IS  1  1  1/  V_/  III    /  t — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

MEDICAL  DEVELOPMENTS 
INTERNATIONAL  LTD 

2012-7247 

10/09/2012 
11/06/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

SHERI  p  COVINGTON 

\S  1   1  l_  III    1  \w /  Vw/  VIIX  Ks  1  Vw/  1  N 

K&L  GATES 

ACCUPAC  MAINLAND  PA  -  EIRS  483S  WARNING  LTRS 

/  V  Vw/  Vw/  \s*  1     1  \  V-/  «    1  v  1 1  V 1  1  v  1  t  \  1  X  1 — '  1    1     /  \        1  III  v/  3      t  vuC  j    V  V  /  V 1  1 1  VI  1  1  VJ  \S\    ^  1  1  I  ? 

ETC  9/10  TO  PRESENT 

2012-7248 

10/09/2012 
11/06/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

KAREN  E  PETERSON 
ENTELLUS  MEDICAL 

ENTRIGUE  SURGICAL  INC  -  ENTRIGUE  SINUS  DILATION 
SYS  K121351 

2012-7249 

10/09/2012 
11/06/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  V  '  L_/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DANIEL  H  LEVI 

PAUL  WEISS  RIFKIND  WHARTON 
&  GARRISON 

LX    \-A  1  \  1  11  11       \  '  1  V 

SCIELE  PHARMA  INC,  SHIONOGI  PHARMA  INC,  SHIONOGA 
INC  -  REGULATORY  MTG  NOTES,  MINS  1/07  TO  12/10, 
CMPLNT 

2012-7250 

10/09/2012 

ORA/ 

NUMBER  OF  LEVEL  1  RECALLS  2007-2012 

1  M  KJ  1 V  1  1  '  1—  1  1   Vw/  1       1  l_  V  1— —  l_     1     1  1 1  Vw/  /  \  1  1  K-l   C—  \J  \J  1     L—  \J  1  L— 

11/06/2012 

ORA/ 

ORA/OE/ 

ORA/OE/ 

WILSON,  DAWN 

2012-7251 

L_ v/  1  £_     /  1 

10/09/2012 

1  \Jl  \J\J/  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    J  /  /  V/  Vw/  1  v  1  1      11  \  '  Lh'  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

MICHAEL  R  COHEN  RPH  MS  SCD 

1  v  1  1  W  1   1 1  V  l_  L_   1  1    Vw/  Vw/  1   1  l_  1  VI    III     II    1  V 1  \—t   \J  W  J  / 

MEDWATCH  RPTS  CODED  AS  MEDICATION  ERRORS  9/1- 

1  V  1  1  IS  V  V  I  \  1   \S  1    1     1   l  1       1  Vw/    Vw/  Vw/  1 — /  1       1  /    / V  \S    1  V  1  1  l_/  1  WM  1    1  Vw/  1  VI     1       1    1  1    1  Vw/  1   I  Vw/    \J  1  1 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INSTITUTE  FOR  MEDICATION 
PRACTICES 

31/12 

2012-7252 

10/09/2012 
11/06/2012 

ORA/ 
ORA/ 

SAMANTHA  MYERS 

ROANOKE  TRADE  SERVICES  INC 

G  &  G  PRODUCE  LLC  -  ENTRY  #BYX00430680  FDA  NOTICE 
OF  ACTION,  INVOICES,  BILLS  OF  LADING,  ETC 

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Control  # 


Reed  Date  / 
Due  Date 


Action  Office 


Signature/  Requester 


Subject 


FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

FDA/OGROP/ORA/SW- 
FO/SWID/SWID-CB/ 


2012-7253 


10/09/2012 
11/06/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


VASSLLIOS 

CHRISTODOULOPOULOS 
SANDOZ  CANADA  INC. 


NDA  202-872  -  RECS 


2012-7254 


10/09/2012 
11/06/2012 


FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 


RICHARD  WANG 
TENZING  GLOBAL 


NU  SKIN  ENTERPRISES  -  AGELOC  CMPLNTS, 
INVESTIGATION 


2012-7255 

10/09/2012 
11/06/2012 

FDA/OO/OFBA/OAGS/ 

KIMBERLY  LEGROW 
GRYPHON  SCIENTIFIC 

SOLICITATION  FDA-12-223-SOL-00058  -  PROPOSAL  RVW 
PANEL  RATING  NOTES 

i  ni  >i  i  i     i  in  i  1 1  <i\j ,  i  xv_/  i  i  \j 

2012-7256 

10/09/2012 
11/06/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

PETNET  SOLUTIONS  INC,  KENT,  WA  -  EIR,  483  2/12 

2012-7257 

10/09/2012 
11/06/2012 

ORA/ORM/ 
ORA/ORM/ 

GAIL  LESSICK 

LACHMAN  CONSULTANT 
SERVICES  INC 

DRUG  COMPANIES,  MEDICAL  DVC  MFRS,  BIORESEARCH 
MONITORING  (BIMO),  ETC  -  FOREIGN  AND  DOMESTIC 
INSPS  8/1-31/12 

2012-7258 

10/09/2012 
11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

GREGORY  GREEN  ESQ 
GREEN  LAW  FIRM  PC 

METHERGINE  (METHYLERGONOVINE  MALEATE)  -  AERS, 
LBLG,  STORAGE  RECS 

2012-7259 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 
VENABLE  LLP 

BLACK  COHOSH,  SOY  ISOFLAVONES  -  CAERS 

2012-7260 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 
VENABLE  LLP 

PRIVATE-LABEL  MENOPAUSE  DIETARY  SUPPLEMENT 
PRODS  - CAERS 

2012-7261 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 
VENABLE  LLP 

ONE-A-DAY  WOMEN'S  MENOPAUSE  FORMULA  DIETARY 
SUPPLEMENT  PRODS  -  CAERS 

2012-7262 

10/09/2012 
11/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 
VENABLE  LLP 

ESTROVEN,  ESTROVEN  MAXIMUM  STRENGTH,  ESTROVEN 
NIGHTTIME,  ETC  -  CAERS 

2012-7263 

10/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 

REMIFEMIN,  REMIFEMIN  GOOD  NIGHT  -  CAERS 

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V_/Ul  ill  Ul  TT 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  ricLIUtJoLci 

OUUJtfOl 

11/06/2012 

VENABLE  LLP 

2012-7264 

10/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

TODD  A  HARRISON 

BLACK  COHOSH,  SOY  -  CAERS 

1 1/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

VENABLE  LLP 

V  1—  1  *l  1  \  is)  1  l_    1_  1_  1 

2012-7265 

10/09/2012 
11/06/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  9/17-21/12 

2012-7266 

10/10/2012 

1  \Jl     1  \Jl  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

Tvrah  1  Milp^ 

i  y  i  d ii  i—  ■  i v 1 1 iuo 

ZOMIG  -  SBA 

L.  Vw/  1  V  1  1  V^l           K-)  1  '  1  \ 

11/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DJA  Global  Pharmaceuticals,  Inc 

2012-7267 

10/10/2012 

1  \JI     1  \JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \  '  IS  1  1  1/  \s  III    /  IS  1  L-/  1  / 

Tu  Tu 

NDA  020304  -  SBA 

1  *J  \S  1   \    v/  L—  \J      \J    1^         Vw/  IS  1  V 

11/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

CSL  BEHRING 

2012-7268 

10/10/2012 

1  \JI     1  \JI  L—\J\l— 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  11   1/  W  \  '  l_  1  1/  1  /  1    Vw/  1/ 

Fli^ahpth  NppIv 

1 — MOClk/t>LI  1    1  lOUl  y 

St.  Jude  Medical 

P840001/S185 

2012-7269 

10/10/2012 

FDA/OC/OES/DFOI/ 

i    i—'  /  v/  \w/  Vw//  Vw/ 1 —  vJ/  i—/  i  Vw/ 1/ 

Makit  anfi 

K021356 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Makit  apS 

2012-7270 

10/10/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

NORTH  DALLAS  HONEY  CO  -  COMPLAINT 

11/07/2012 

DO/DAL-CB/ 

\s  \s  <  is  1  \  i_  \j]s)i 

North  Dallas  Honey  Company,  LP 

2012-7271 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

1  /  V*//  Vw/  1   1  1    \S  IS)/ 

Travis  Siverson 

BIRCHWOOD  LABORATORIES 
INC 

HYDROX  CHEMICAL  CO,  ELGIN,  IL  -  WARNING  LETTERS, 
483  RECALL  ETC01/01/2008  -  12/31/2009 

i  V/  \-f  ,    I   1 1_  V-/ 1  \  l_  1  „    1       1  Vw/ V/  1  /  \J  1  /  L—\J\J  \J          1  L—l  O  1  /  £—  V/  V/  *_/ 

2012-7272 

10/10/2012 

1  \JI   1  \JI  t—\J\C— 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L*/  1  11   1/  Vw/  V  '  l_  1  1/  IS  1    Vw/  1/ 

Richard  O  Wood 

1  1 1  Vri/ 1  1  dl  \A   Vw/  i    V  V  vUU 

the  Wood  Burditt  group 

CDRH  PROMOTION  AND  ADVERTISING  UNTITLED  LETTERS 

Vw/  \S  1  1 1   1    1     11  Vw/  1  V 1  Vw/  1  1  \s  1  N    /  V 1  >l  IS   1  \  IS  V  1  1  1  1  1  v/  1  1  N  Vw^    \S  1  *l  1   1   1  1—  1  l_/    1  l_  1    1  1  1  I  Vw/ 

01/01/2010-  10/09/2012 

2012-7273 

10/10/2012 
11/07/2012 

ORA/ 
ORA/ 

Econ  One  Research 

OFFICIAL  ESTABLISHMENT  INVENTORY  RECORDS  FOR 
INDUSTRY  CODE  59 

2012-7274 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

ORA/ 

ORA/ 

Aaron  Pressman 
Reuters  News 

NEW  ENGLAND  COMPOUNDING  CENTER,  FRAMINGHAM, 
MA  -  WARNING  LETTER  FOLLOW  UP  RECS 

2012-7275 

10/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

SHASTA  TECHNOLOGIES  -  CORR  WITH  FDA  RE  GENSTRIP 

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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

1 1/07/2012 

1    1  I\J  1 1  (—  w  1  C- 

OC/COS/OES/ 
OC/COS/OES/ 
OC/COS/OL/ 
FDA/OC/OES/DFOI/ 

1  athrnn  R,  Ranp  1  1  P 

ETC 

2012-7276 

10/10/2012 

1  \JI     1  \JI  L—\J\l— 

11/07/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    I—/  / V/  Vw/ 1 V  1 1      \  1  \J\—}\  1  1/  v_/ \J\*J  \—Jt  L-/  L-/  V_/  1 VI/ 

ALFB/ 

Rirharri  O  Wood 

the  Wood  Burditt  group 

CBER  PROMOTION  AND  ADVERTISING  UNTITLED  LETTERS 

V/  I  )  1  111     11  Vw/  1  V 1  Vw/  1  1  V_/  1  N    1  V 1  M  l_/    1  \  1— /  V  1  1  1  1  1  K->  1  1  N  Vwi    V/  1  *J  1   1   1   L_  1  L/    1  1       1    1  1  1  I  Vw/ 

01/01/2010-  10/09/2012 

2012-7277 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

JOHNSON,  JILL 

ARKION  LIFE  SCIENCES,  NEW  CASTLE,  DE  -  483  4/1 1  TO 
PRESENT 

2012-7278 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

JOHNSON,  JILL  . 

STERLING  TECHNOLOGIES,  BROOKINGS,  SD  -  483  4/1 1  TO 
PRESENT 

2012-7279 

10/10/2012 

1  \Jl    1  \Jl  C—\J   1  L— 

11/07/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

JOHNSON,  JILL  . 

APS  BIOGROUP  PHOENIX  AZ  -  483  4/1 1  TO  PRESENT 

/  \  1     Vw/    1  1 1  Vw/  V_H  1  l  V/  \J  \     ^    \     \   \  Vw/  l_  1  N  1  /  V  .    /  V  L              i  VJ  O   TV    1    1      1  Vw/    1     1  1 1_  v_/  l_  1  M  1 

2012-7280 

l_  \_/  i  £_    /  £_  v/  v/ 

10/10/2012 

1  \JI     1  \JI  L—\J\l— 

11/07/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

1    ]  /  /  V/  Vw/        1  I  V»/  1    /  \w/  1  1/  V/  \J  V  V     1    V.*//  L/  /  \  1  

DO/DAL-CB/ 

JOHNSON,  JILL  . 

LEGACY  FOR  LIFE  OKLAHOMA  CITY  OK  -  483  4/1 1  TO 

i  i  v_/  /  \  v/  i    i   Vw/  i  i  i—  1 1    i_ „  Vw/ 1  \  i  /  v  i  i  Vw/ 1  v  i  /  \  Vw/  ii    i  ,  Vw/ 1  \          v/  *_/  "  /  ii     i  v_/ 

PRESENT 

2012-7281 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNSON,  JILL. 

VMI  NUTRITION,  SALT  LAKE  CITY,  UT  -  483  4/1 1  TO 
PRESENT 

2012-7282 

10/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

SOFTGEL  TECHNOLOGIES  INC,  LOS  ANGELES,  CA  -  483 

11/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

JOHNSON,  JILL 

4/11  TO  PRESENT 

2012-7283 

10/10/2012 

1  \Jl    1  \Jl  t—\J\C— 

11/07/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

JOHNSON,  JILL  . 

AMERICAN  COPAK  CORP  CHATSWORTH  CA  -  483  4/1 1  TO 

i  \ \ v 1 1_ i  i 1  Vw / 1  \ i  >j  V-/ Vw/ 1   I  \ i  v  v/ Vw/ 1  ii    „  v/ 1  i /  v  i  v-/  v  v  v*/ 1  i  i  i  i-  Vw / y  \         v/ v/  ^/  i  i     i  v-/ 

PRESENT 

2012-7284 

10/10/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

SUSAN  B.  MILLS 

NATIONAL  BEEF  CALIFORNIA  LP  -  EIR  1/09  TO  PRESENT 

11/07/2012 

DO/LOS-CB/ 

WEINBERG  WHEELER  ET  AL 

2012-7285 

10/10/2012 

1  \JI     1  \JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  1— /  1  / 

IMMUNEX  CORP  -  ENBREL  ENTANERCEPT  AER 

1 1 V 1  1  V 1  V/  1  X  1  /  V   V/  Vw/  1  1 1            1  1  M  1  '  1  1 1_  1       l_  1  N  1  I  \  1  N  1— —  1  1  Vw/  1  1      1     /  V  l_  1  I 

11/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

AHEARN,  DONALD 

2012-7286 

10/10/2012 
11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 
OC/OCC/ 

HENSON  SR.,  J.  DONALD 

MTG  BETWEEN  J  DONALD  HENSON  CDRH  AND  CHIEF 
COUNSEL  -  DOCUMENTATION  OF  CONVERSATION  7/03/12 

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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7287 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

i  i— / 1  \i  \w/     i  i  v_/  i  /  v_/ 1  in/  \_y  i      i  V-// 1    i  ii 

DO/PHI-CB/ 

ELENA  HOWELL 

i  i  i  i  Mn  i  iv/  v  v  i  i  i  

HOGAN  LOVELLS  LLP 

HALEDEMAN  MILLS  MANHEIM  PA  -  YELLOW  CORN  MEAL 

i  1 1  \  i  i  l/  i  ivini  m  iviii  i  o  j  ivinivii  ii  iivi,  i  y \      i  i  i  i  v/vv  \_/\_/i  iivi  ivii  i  \  i  

RECALL 

2012-7288 

10/10/2012 
11/07/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

L/  n  '    I  /  L_  1      V/  !  ' 

DONLAD  N.  BLUE 
ZETETIC  INC 

2  SOAP  -  ENTRY  NO  BGK-  0387652 

2012-7289 

10/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

GREGORY  H.  LEVINE 

GEN1 100033 

11/07/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

ROPES  &  GRAY  LLP 

2012-7290 

10/10/2012 
1 1/07/2012 

F  D  A/OG  ROP/O  RA/S  W-  FO/D  AL- 
DO/DAL-CB/ 

OC/COS/OES/ 

OC/COS/OES/ 

MICHELLE  JONES 

n  i  ini  i — r>/™>  \  ir>  ni  ini —  i  i/~\kii — \/ 

BURLESONS  PURE  HONEY 

NATURE  NATES  HONEY,  FRISCO,  TX  -  FINES, 
JUDGEMENTS,  CORR,  ETC  3/30/1 2  TO  1 0/5/1 2 

2012-7291 

10/10/2012 

1  V//    1  \JI  L—\J\t— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          L/  /      V/    Vw/  |  V  1   1             1     /    \w/   L/    1       11       1/    Vw/  \w/  1— —  1       1/     1  >     1         Vw/  1/ 

JOHN  P  HARLOE  JD  PhD 

\J  \w/  1      1  1    N       1        all  1    \  1     I  1— Vw/  1         ,      \J  L/  B|        ||  l_/ 

OBSTETRICS  &  GYNECOLOGY  A/C  MTG  RE  PELVIC  MESH 

Vw/  l  >  V/  |  I       |  |  1 1  \_J  \_j    l_X    V_/   1  1  N  1  V/  Vw/  ]  Vw/  V_/  |     /  \/  V/    |  V 1  1  Vw/    1  1 1_    1     1  l_  V  1  V/    |  V 1  1  V/  1  1 

11/07/2012 

OM/OMP/DODM/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FREESE  &  GOSS,  PLLC 

9/8/1 1 

2012-7292 

10/10/2012 

1  \JI   1  V//  t_  V/  1  £— 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  VwS  L/  1  11   1/  Vw/  V/  l__  1  1/  1  /  1    Vw/  1/ 

OM/OMP/DODM/ 

JOHN  P  HARLOE  JD  PhD 

%J  Vw/  1      1  1   V|       |        all  1    \  1     I  1— Vw/  1         ,      \J  L/  B|        ||  1  / 

FREESE  &  GOSS,  PLLC 

OBSTETRICS  &  GYNECOLOGY  MEDICAL  DVCS  A/C  9/8/1 1  - 

Vw/  Lw/  V/  |  I       |  |  1 1  V/  V/           \w/   1  1  VI  l_  V/  Vw/  1_  Vw/  V_/   |     |  V 1  1  L/  1  V/  /  V  L_  1 — /  V  V/  V/   /  V/  V/    \JI  \JI    1  1 

JOURNAL  ARTICLES,  DATABASES,  SPREADSHEETS,  ETC 

2012-7293 

10/10/2012 
11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHN  P.  HARLOE,  JD,  PhD 
FREESE  &  GOSS,  PLLC 

OBSTETRICS  &  GYNECOLOGY  MEDICAL  DVCS  A/C  9/8/1 1  - 
JOURNAL  ARTICLES  DATABASES  SPREADSHEETS  ETC 

vJ  Vw/  V/  1  1 1  *J  /  \  1       1  \  1  1  1  1  V/  1—  1  V_^  ,  1 — '  1  \  \  1  \  \—)  1  \  V/  1— —  V/  ,    V/  1     11 1—  /  \  L/  U  1   1  1  1       1  V_J  ,    l_  1  V/ 

2012-7294 

10/10/2012 
11/07/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

L/  v-//  1  \l  VI  *J    V/  L// 

FDA/OMPT/CDRH/OCER/DFOI/ 

DAVID  A.  BORESI 
THURMAN  LAW  FIRM 

MEDTRONIC  INC  -  INFUSE  BONE  GROWTH  ACCELERATOR 
PROD  MDRS  CLNCL  TRIAL  RECS  PROTOCOLS  ETCPRO 

1     1  l  Vw/  l_/    |  V 1  1 — /  1  WJ  m    V/ 1_  1  V|  Vw/  I        III  1 1  \  l_    1  1  ^V/V/  3    1     1  IV/  1  Vw/  V/  V  '  L_  V/  ,    l_  1  V/  1     11  V_/ 

2012-7295 

10/10/2012 

1  \JI     1   W  /  C—\J    1  L— 

11/07/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

i  i — '  /  v/  Vw/  v/  i  i  v_/ 1   /  Vw/ 1       v/  v/  v  v    i   v_//  i  w \  i  vi 

DO/KAN-CB/ 

SUSAN  B  MILLS 

V/  V/  V/ 1  \  1  VI  I— J  m    1  V  1  1  i—  L_  V/ 

WEINBERG  WHEELER  ET  AL 

NATIONAL  BEEF  PACKAGING  CO  LLC  -  EIR  1/09  TO 

1  HI  \  1  1  V_/  1  VI  /  \  1   l— J  \  1  1       1    flW  1  V 1  \  V/  1  1  V|  V_/    V/  Vw/    1  E  V/        l_  III     1  /  \J  v/     1  Vw/ 

PRESENT 

2012-7296 

10/10/2012 

1  \JI   1  V//  Ll>  1  L 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/ \J  l__  1  1/  1  /  1    Vw/  1/ 

CHRISTINA  M  MIRACLE 

V_/  1   1  1  l  1  V/  1  1  1  VI  /  \    1  V  1  ■    1 V  1  1  1  1 1  \  V/  1—  1  

HILL  ROM 

K863047'  K91 4351  ■  K91 5779 

1  V \J  V/  *_/  \J    i  /   ,    1  V  *_/  1    i^Xw*  v/  1  -    1  V  *_/  1  v/  /    /  v/ 

2012-7297 

10/10/2012 

1  \JI    1  \JI  L—\J   1  L— 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  / V  Vw/  1  v  1  1      1  /  V/  l_/  1  11   1/  W  V/  l_  1  1/  1 — /  1    Vw/  1/ 

CHRISTINA  M  MIRACLE 

V/  1   1 1  1 1  Vw/  1  1 1  VI  /  \   1  v  1  ■    1  V  1  1  1  1 1  \  V/  l_  I  

HILL  ROM 

K921168'  K926140'  K944779 

1  vju  1    1  \J\J  ,    1  V \Z L_ V/  1     i  V/  ,    1  V *_/           1    1  \J 

2012-7298 

10/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

McKENZIE  CATO 

SENTREHEART  INC  -  LARIAT  II  SUTURE  DELIVERY  DEVICE 

11/07/2012 

Hyman,  Phelps  &  McNamara,  P.C. 

K090385 

2012-7299 

10/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

MATTHEW  A.  ZEPNICK 

INDIVIDUAL  RECS 

11/07/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

EDELSTEINS  FAEGENBURG  & 
BROWN  LLP 

2012-7300 

10/10/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

JEANETTE  GOOGE 

MORTON  SLT  INC,  SOUTH  HUTCHINSON,  KS  -  483,  EIR 
MOST  RECENT 

Page  24  of  895 


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Total  Records:  9990 


IjUl  ill  Ul  TT 

MOLIUI 1  VjMMOtJ 

QinnQti  iro/  Rom  loctor 
Oiy  1  laLUl u/  lic^UtJoLoI 

OUUJtfOl 

Due  Date 

11/07/2012 

MORTON  SALT  INC 

2012-7301 

10/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    U  1  \l  VJ  1  v  1  1      I  /  VJ  U  1  1  1/  \-s  III    /  1 — f  I  ]  /  I  / 

MATTHEW  VENTRESCA 

i  vin  i   i  i  1 1— _  v  v    v  i— _  i  \i  i  i  l  i__  v/v/n 

CODEINE  USE  IN  CHILDREN  -  AERS 

v/  Vw/  J  /  l_  1  1  >J  1        V_/  VJ  1— —    111  Vw /  1   1  1  1  1  /  1  1 1_  1  M        1  \  l_  1  IVJ 

1 1/07/P01? 

1  1  l\J  l  1  <—\J  \  c 

FnA/OMPT/nnFR/DRP/nmp/ 

\  vj r\i  vj'ivi n  i  /  \j \-J \  rv i  \  i  /  l/ i vj i  i 

MCMA9TFR  1 INIVFR9ITY 

1 V 1  \J 1 VI  /\vj  1  1  1  1  U 1  N  1  VI  1  1  vj  1  1  I 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  U  1  1  1/  VJ  III    /  1 — '  1  U  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  \J  U  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

2012-7302 

10/1 1/2012 

1  \Jl    1    1  /  t—\J  1  £_ 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  U  1    Vw/  1/ 

BAXTER  INTERNATIONAL  INC  BAXTER  HEALTHCARE  CORP 

l— J 1  \/\  1  1  II    II  V  1  1  1  1 1  V/  \  1  1  Vw /  1  M  /  \  1       MM  VJ  ,    U  /  V  /  V  1  l_  1  1    1   1  1  r  \  \       1  1   1  VJ  1  \  1  1 1        VJ  VJ  1  11 

1 1/08/2012 

1     1  /  \J\Jl  L-\J  1  C 

Snrvpvor  C?init?il 

w  LI  1  V  C  y  vj  1  wa[wJILCll 

-  483  01/01/2009  -  10/04/2012 

?01  ?-7^0^ 

10/1 1/P01? 

I  \J!    I    I  /  L.U  1  t— 

FDA/On/OF^/DFOI/ 

n  L/rA/  >ju/v/r_o/ i— '  i  w  1/ 

FtpH  Mamnim 
ncu  i v i d 1 1  iuu  1 1 

IFRKY  PFT  TREATS  -  IN^PFCTION^  COMPI  AINT9 

U 1  I  1 1\  I   I  I  I    in  I  r\  i  o     1 1 N  O  \  I  vj  i  i  vj  i  mo  ,  vj  vj  i  v  i  \  I  r\  i  in  I  o 

11/08/2012 

Fox  Five  News  New  York 

01  /0Q/P007  -  1  0/0Q/P01  ? 

2012-7304 

10/11/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

T.  Christian  Miller 

MCNEIL  CONSUMER  HEALTHCARE  -  CORR  TO  FDA 

11/08/2012 

DO/PHI-GB/ 

PROPUBLICA 

05/01/2009  -  08/30/2009 

FDA/OGROP/ORA/SE-FO/SJN- 

DO/SJN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  U  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/COS/OES/ 

OC/COS/OES/ 

2012-7305 

10/1 1/2012 

1  \JI  1  1  /  t—\J  1  i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    i  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1 — '  1  l_/  1  / 

Rarhpl  Johnson 

1  IdVvl  IUI   V/  KJ  1  II  IOV/1  1 

EPOGEN -  APPROVAL  RECS 

i  i    vj  vjj  i_  i  m      i  \  i    i    i  i  vj  v  /  v  i—  i  1 1_  vj  vj 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  VJ  u  1  1  1/  V/  III    /  U  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7306 

10/1 1/2012 

1  \JI  1  1  /  t—\J  1  i— 

OC/OOPD/ 

Vw/  V//  Vw/  Vw/  1     l_/  / 

Rarhpl  Johnson 

1  IdVvl  IUI   \J\Jl  II  IOV/1  1 

NITRIC  OXIDE  -  ORPHAN  DRUG  DESIGNATION 

111  1  1  11  VJ    VJ  /  V  1  U  1             VJ  III     1   1 1  \  1  N    U  1  I  VJ  VJ    U  1  VJ  1  VJ  1  N  /  \  1  1  VJ  1  M 

11/08/2012 

FDA/0MPT/0SMP/00PD/ 

FOI  Services,  Inc. 

2012-7307 

10/11/2012 

FDA/OC/OES/DFOI/ 

Johnathan  Rickman 

FOIA  LOG  09/24/2012  -  10/05/2012 

11/08/2012 

FDA  NEWS 

2012-7308 

10/11/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Emily  Bartkowicz 

PELVIC  MESH  PRODUCTS  -  INVESTIGATION  RECS, 

1 1/08/201? 

OC/COS/OES/ 

V_/  \J/  Vj  VJ  vj/  Vj  | — \j/ 

AKFRMAN  9FKITFRFITT  ATTYC; 

r\ r \  1  1  1 1 V l/v  1  VJ  Ol  IN  1  1  III    1  1    1    i  \  1    1    I  vj 

ANALYSIS 

OC/COS/OES/ 

0C/C0S/0L/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

2012-7309 

10/11/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Rachel  Johnson 

FCN  524,  FAP  9B3477 

Page  25  of  895 


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Total  Records:  9990 


Pnntrnl  if 

rit?OU  Udlc  / 

MOLIUll  wlllUc 

OlyildLUlu/  ntsLjUubLci 

Ci  i  il™iiQ/^t 

ouujfcfoi 

Due  Date 

11/08/2012 

FOI  Services,  Inc. 

2012-7310 

10/1 1/2012 

1  \JI   1    1  /  C—\J  \  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  V_/  III    /  I — '  1  L/  1  / 

l_/CU  1  1      1    WQOUUUI  1 

NDA  21-847 

1  *J  1 — /  /   V   L—  1      V/    1  / 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

NPS  PHARMACEUTICALS 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-731 1 

10/1 1/2012 

1  \Jl    1    1  /  t—\J  1  £_ 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  V-/  1    v//\  1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

TRUEHOPE  EMPOWERPLUS  -  AERS 

1  1  l  Vw^  1  1   1  Vw/  1     l_    1  1  V 1  1     Vw/  V  V  1— —  III     L_  V/  U        /  \  1  1  I  Vw/ 

1 1/08/2012 

CBC  (AMERICA!  CORP 

V/  1  J  V/    1  I  \  \  V  1  1  1  1 1  Vw//%  J    W  Vw/  1  11 

2012-7312 

10/11/2012 

FDA/OMPT/CTP/OD/ 

Kevin  Aldridge 

LIST  OF  REGISTERED  CIGARETTE  TUBE  MANUFACTURERS 

11/08/2012 

Aldridge,  Kevin 

2012-7313 

10/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

T.  Christian  Miller 

JOHNSON  &  JOHNSON  -  MEETING  MINUTES,  AGENDAS, 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PROPUBLICA 

BRIEFING  MATERIALS  ETC  FOR  02/19/2010  MTG  WITH  FDA 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  \—s  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

2012-7314 

10/1 1/2012 

1  \JI  1  1  /  t—\J  1  i— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— / 1  \!  Vw/  1  v  1 1      1  /  v/  lw/  l  ll   1/  v/  V/  1— —  1  1/  1  /  1    Vw/  1/ 

Rphpppa  fihplhnrnp 

1   l  C7  KJ  t7  Vj  Vj  CI   VJ  1  1  V/  1  k/  U  1  1  1 V/ 

K092318 

1  \\J\SL-\J    1  \J 

1 1/08/2012 

1    1  /  \J\Jl  C—\J  1  C 

FllinQP  Tprhnnlnnipci  Inr* 

1  1 1 1  UoC     1  UOI  II  Iv/IUUIwO^    II  Ivi 

201  2-731  5 

10/1 1/P01? 

FDA/nMPT/nnRH/nnFR/nFDi/ 

^amantha  ^IpHH 
Odi  i  idi  i ii  id  oicuu 

K04P800 

1 1/08/2012 

i  i_ii  o  o ^- +L-. ;    ni  o 

Hall  &  bethi,  PLC 

2012-7316 

10/1 1/2012 

FDA/OGROP/ORA/bE-FO/ATL- 

TORREY  COPE 

KIMBERLY-CLARK  CORP,  RObWELL,  GA  -  CMPLNTb,  FOI 

1 1/08/2012 

DO/ATL-CB/ 

cini  i —  \/  a  i  iptim  i  i  n 

bIDLEY  AUbTIN  LLP 

REQUESTS,  INSPS,  ETC  3/20/1 0  TO  1 0/5/1 2 

FDA/OMPT/CDRH/OCER/DFOI/ 

OC/COS/OES/ 

V/V//  Vw/  Vw/  V — )l  Vw/  1 — 

on/no^/OF^/ 

UV/U/  V_/  1 —  O/ 

OC/COS/OL/ 

v_/  v_//  V/ V/  O/  V/ 1— / 

FDA/OC/OES/DFOI/ 

AA-(  A   70  ^  "7 

2012-7317 

10/1 1/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

A  1    1    1  O       N  1    M    A  /-n  M  ^l  A  / 

ALLIbON  M  AGNEW 

a  r~> i /~\ r  * r~ r\  ik  i /~»     i r  jini —  i  i  a  h\ \  //~»  n n /~\  1 1 —  /~> ~n  1 1  -rn i  a  i 

ABIOMED  INC  -  IMPELLA  DVC  PROJECT  II  TRIAL 

11/08/2012 

PILLSBURY  WINTHROP  SHAW 

STATISTICAL  ANALYSIS  PLAN 

W  1  /  \  1  1  ^-J  1  1  V/ 1  \  L_  7  \  1  HI  V 1—  1  VwJ  1         1     1  /  \  1  VI 

PITTMAN  LLP 

2012-7318 

10/1 1/2012 

1  V//     1      1  /  fc- V/    1  L— 

OM/OMP/DODM/ 

Vw /  1  V 1/  V_/  1 V  1  1    /  1— /  Vw/  lw/  1 V  1/ 

JAMES  C  MINGEE 

\J  1  V 1 V  1  1— —  \—J   V/    1 V  1  1  1  N  V_^  1— —  l__ 

GENERIC  DRUG  USER  FEE  AMENDMENTS  MTG  -  TRANS 

V_H  1  1  *J  l_  1  II  V/    lw/  1  1  V/  V_/    V_/  V/  1  1  1    1  1— —  l_  t  VI V  1  1— —  1  M  lw/  1 V  1  1— —  1  VI  1  \J    1  v  1  1  Vwl          1  1  1 V  \  1  V|  u 

1 1/08/2012 

1     l  1  \J \JI  i. —  V/    1  L — 

MINGEE  &  ASSOCIATES 

9/21/12 

2012-7319 

10/11/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

NATHAN  A  BEAVER 

DVC  REGISTRATION  AND  LISTING  DATABASE  2012 

11/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

FOLEY  &  LARDNER  LLP 

2012-7320 

10/11/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

INDIVIDUAL  RECS 

Page  26  of  895 


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Total  Records:  9990 


\_/UI  III Ul  tt 

MO  LIU  1 1  WIMOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUI  u/  licUjUtJbLoi 

OUUJtfOl 

Due  Date 

11/08/2012 

DO/DAL-CB/ 

CONORS,  ANTHONY  ROBERT 

ORA/OCI/ 

ORA/OCI/ 

FDA/OF/GFSAN/OCD/EOS/ 

FDA/OGROP/ORA/SW- 

FO/SWID/SWID-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  1  \i  V_/ 1 V  1  1      11  W  l_/  1  1  1/  W  III    /  [_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V_/  L-/  |  |  1/  V_/  III    /  [_/  1 |_y  |  / 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  1  \i  Vw/ 1 V  1  1      1  /  V/  1— /  1  1  1/  V_/  III    /  l_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7321 

10/11/2012 

FDA/OGROP/ORA/PA-FO/SAN- 

GARY  C  COOPER 

ENTRY  #D52-0940626-8  -  LAB  RESULTS 

11/08/2012 

DO/SAN-CB/ 

GARY  C  COOPER  LAW  OFC 

201 2-7322 

10/1 1/2012 

1  \JI    1     1  /  L-\J  1  C 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    1  '  1  \i  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  L/  1  L/  1  / 

PIREXICAM  -  AERS 

1     III  l—  /  V  1  Vw/  /  VI V  1        1  \  1— —  1  I  u 

1    1  l\J\JI  <—\J  \  C— 

FnA/OMPT/cnFR/ORP/nmp/ 

WOOD9  10R277R  I  FON 

rUA/CJlVlr  1  /GUhK/OKr/UlUr/ 

FDA/OMPT/GDFR/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \J  LJ  1  1  1/  W  III    /  [_/  1  L-/  1  / 

2012-7323 

10/11/2012 

FDA/OC/OES/DFOI/ 

MICHELLE  L  MEJIA 

PERISHABLE  SPECIALIST  INC  -  ALL-01 1 5379-0,  ALL- 

FDA/OC/OF^/DFOI/ 

^ANDI  FR  TRAVIS  ft 

O/A 1  N  VJ  L_  1  1  l    1  1  \r\  V  1 0  CX 

01 1 5922-7  NOTICES  OF  ACTION, REDELIVERY  REQUESTS; 

ORA/ 

ROSENBERG  PA 

SPIECH  LLC  -  REFUSALS 

ORA/ 

FDA/OGROP/ORA/SE-FO/FLA- 

DO/FLA-CB/ 

1  '  \Jt  1    1  1  \    \J  VJ! 

2012-7324 

10/11/2012 

FDA/OC/OES/DFOI/ 

MICHELLE  L  MEJIA 

DEEP  VALLEY  FARM  INC,  FIGHT  BAC  -  DRUG  FACILITY 

1 1/08/2012 

1     1  /  \J\Jl  L-\J  1  C 

ORA/ 

SANDLER  TRAVIS  & 

Ur\l  M  1— /  1  1  11    II  In  v  1  w  LX 

REGISTRATION,  WARNING  TLRS,  PROD  LISTING;  EMPACK  - 

ORA/ 

ROSENBERG  PA 

1  l  V_/  V-/  1  1  V  L/  1  1   1  Vwi    1     1  \ 

LIQUIDATED  DAMAGES  RECS,  ETC 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

2012-7325 

10/11/2012 

FDA/OC/OES/DFOI/ 

MICHAEL  NAZERIAS 

CARDINAL  HEALTH  414  LLC,  SEATTLE,  WA;  LAS  VEGAS,  NV, 

11/08/2012 

PETNET  SOLUTIONS  INC 

MEMPHIS,  TN,  ETC  -  EIRS,  483S 

2012-7326 

10/1 1/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1  1/  W  III    /  L*/  1  J  /  1  / 

MICHAEL  HAWOTTE  ALFACELL  CELEBREX  FLOMAX  - 

1 V  1  1  \—t  1     1  1    \  \  1—     1     1  /    \  V  V  Vw/    1      1  1— —  ,        1    \  \  1     MW  1  1  1  .     Vw/  1— —  1  l__  1  '  1    1  ^_/\ ,     1      l_  Vw/  1 V  1 1    V  /  V 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

MCCASH,  MARY 

RECS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

Page  27  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OO/OFBA/OAGS/ 

2012-7327 

10/11/2012 
11/08/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

UU/N  Y  IVUL/b/ 

ONA SCANDURRA 
COUNTRY  LIFE  LLC 

COUNTRY  LIFE  LLC,  HAUPPAUGE,  NY  -  EIRS,  483S  6/10  TO 

DDCCCMT 

rritotlN  I 

2012-7328 

10/11/2012 
11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DR  YA  PING  LEE 

CURTIN  UNIV  SCHOOL  OF 
PHARMACY 

ORAL  PROTON  PUMP  INHIBITORS  (PPI);  OMEPRAZOLE, 
ESOMEPRAZOLE,  ETC  -  AERS 

2012-7329 

10/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

LYNAE  CHANG 

SYN  TECH  PHARM  AND  TECH,  SINYING  CITY,  TAIWAN  - 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Boscogen,  Inc. 

INSP  5/12 

2012-7330 

10/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

WILLIAM  G  GAINER 

RANBAXY  PHARMS  -  MINOCYCLINE  LBLG  CHANGE,  CORR, 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TOLIVER  &  GAINER 

APRVL  RECS,  ETC 

2012-7331 

10/11/2012 
11/08/2012 

ORA/ORM/ 
ORA/ORM/ 

DAVID  P  JORDAN 
THOMSON  REUTERS 

FOREIGN  &  DOMESTIC  DRUG  MFRS,  REPACKERS, 
LABELERS,  ETC  INSPS  1/11  TO  12/11 

2012-7332 

10/11/2012 
11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/DFOI/ 

GILLET  #410314,  TONY 

IBOGAINE  -  RECS;  STRANGE  LOOKING  MEAT  SERVED  BY 
GOVERNMENT  EMPLOYEES  -  TESTING  RECS 

2012-7333 

10/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

XANAX,  ZOLOFT,  SLEEP  AIDS,  ETC  -  SLEEP  DRIVING  RECS 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DUBECK  B00004,  ROBERT 

2012-7334 

10/11/2012 
11/08/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

TRAVIS  SCHAFTENAAR 

UBS  GLOBAL  ASSET 
MANAGEMENT 

ANGIODYNAMICS,  QUEENSBURY,  NY  -  483  7/12  TO  9/12 

2012-7335 

10/11/2012 
11/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ROYA  BORAZJANI 
COOPER  VISION,  INC 

DELEFILCON  A  SOFT  CONTACT  LENS  K1 13168 

2012-7336 

10/11/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ROYA  BORAZJANI 

BAUSCH  &  LOMB  -  MESOFILCON  A  CONTACT  LENS 

11/08/2012 

COOPER  VISION,  INC 

K1 13703 

Page  28  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7337 

10/1 1/2012 

1  \JI  1    1  /  (—  \J  I  c 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l—l  1  \l  V_/ 1 V  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

MARY  B  SZALKOWSKI 

ivi/\i  i  i    i  >  \jt-r\Li\v/vvui\i 

INDAPAMIDE  AND  PERINDOPRIL  -  AERS  7/21/12  TO 

1 1  m  is  i  \  i   y  v  i  v  1 1  i—i  i      ni  n  is  i    i  i  1 1 1  v  \s  \s  i    i  1 1 1         ni  i  ivj  /  /  C—  i  /  i  c—    i  \s 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  L-/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

PRISMA  CORP 

PRESENT 

2012-7338 

10/11/2012 
11/08/2012 

OM/OMP/DODM/ 

MARY  B  SZALKOWSKI 
PRISMA  CORP 

NEUROPHARMACOLOGIC  DRUGS  A/C  -  TRANS  9/14/71 

2012-7339 

L—\J    1  L—     1  \J\J\J 

10/1 1/2012 

1  \JI   1    \  1  t—\J  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — /  /  V/  \w/  1  v  1  1      1  /  \w/  \—J  1  1  1/  \-s  III    /  1  f  I  J  /  I  / 

NORBERT  GOTTESMAN 

1  *l  V*/  1   I  IS  1  1  l  1     \s\  V_/  1     1  l__  U  1 V  1 1  \  1  *l 

EISAI  INC  -  DECITABINE  IN.)  OGD  BIOEOV  REOUIREMENTS 

1  1  V  )  1  V 1    1 1  M  W        \—f  I  V_/  1  1  1  \  \  )  1 1  >l  1        1 1  >JvJ    V_/  \S  l—l    l—l  I  V  /  1  V_x  V     1  1 1  Vj<  \S  II  11  1 V  1 1  1  M  1  \J 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

AVET  CAPITAL  MANAGEMENT 
LLC 

2012-7340 

10/1 1/2012 

1  \JI  1  1  /  t—\J  1  t_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      11  \-S  IS  1  1  1/  W  III    /  ( — '  1  IS  1  / 

NORBERT  GOTTESMAN 

1  *l  \S  1   l  IS  1  1  l  1     \s\  V_/  1     1  l__  U  1 V  1 1  \  1  *l 

CELGENE  -  AZACITIDINE  INJECTABLE  SUSPENSION  - 

Vw/ 1  lvj  I  i  *j  I          I  \£.  I  \  \s  1  1  1  is  1 1  x  l       ii  vu  I—  \j  i  I  \  is  l—  l—  VwJ  *s  VwJ  i    i  i  n  Vw/ 1  \s  I  *i 

11/08/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

AVET  CAPITAL  MANAGEMENT 
LLC 

BIEQV  RECS 

2012-7341 

10/12/2012 

1  V//    1  £_/  £_W    1  £_ 

11/09/2012 

OC/OM/OMP/DDM/ 

V/  v//  Vw/  1 V  1/  Vw/  1  v  1  1    /  1 — /  ( — '  1  V 1/ 

CARLA  SCARMAZZI 

Vw /  / \  1  l  [_/  \  \J\/f  VI  1 1 V  1       *    *  1 

KING  &  SPALDING 

DKT  FDA-2012-N-0378 

IS  1  V  I     1    IS  1  \    L_  \J  1  £_    1  vj    \J  O  /  VJ 

2012-7342 

10/12/2012 

1  \JI   1  (— /  t_V/  1  L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

2012-5105 

L_  V/  1  L    J  1  V/  v/ 

2012-7343 

10/12/2012 

1  V//    1  l—l  L—\J    \  L— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L*S  1  11   1/  V_/  Vw /  l_  1  1/  IS  1    Vw/  1/ 

JOHN  HARLOE  JD  PHD 

\J  V_/  1   1  1  >l    1   It  VI   1  L_  Vw/  1        w  J  /    1     1   1  1 — / 

OBSTETRICS  &  GYNECOLOGY  MEDICAL  DVCS  A/C  -  RECS 

\S  \  >  \-J  1  1       1  1  1 1  \—t  \S   l»X    Vwl   1  1  N  1  V/  Vw/  1_  Vw/         1     1  v  1  1  IS  1  V/  /  V  L_    L/  V  W  V_/   /  V/  \s        1  1 1— —  V_/  \S 

11/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

FREESE  &  GOSS,  PLLC 

9/8/1 1 

2012-7344 

10/12/2012 

1  \JI    1  L—l  L—\J\S— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

2012-6121 

L_  V/  1  £_    V/  1  L—  1 

2012-7345 

10/12/2012 

1  \JI    1  L—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

FOI  Services,  Inc. 

2012-5361 

L_  V/   1  L—    \J\J\J  1 

2012-7346 

10/12/2012 

1  \JI    1  L—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

FOI  Services,  Inc. 

2012-5576 

L—\J   1           v/  v/  /  \J 

2012-7347 

10/12/2012 

1  \JI   1  L—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1-/  1    Vw/  1/ 

FOI  Services,  Inc. 

2012-2862 

2012-7348 

10/12/2012 

1  \JI    1  L—l  L—\J\L— 

1 1/09/2012 

1     II  \J\JI  L—\J    1  L — 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

FOI  Services  Inc. 

2012-5996 

l_  V/  1  c_    v/  v/  v/  V/ 

2012-7349 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2011-7845 

2012-7350 

10/12/2012 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 

GLAXOSMITH KLINE  INC  8/9/12;  EXPERIMENTAL 

Page  29  of  895 


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Total  Records:  9990 

Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


11/09/2012  DO/BLT-CB/  SCHARBERG,  DAVID  L  PATHOLOGY  LABS  8/14/12;  TRS  LABS  INC  7/6/12,  ETC  -  483S 

FDA/OGROP/ORA/CE-FO/CHI-  6/12  TO  8/12 

DO/CHI-CB/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 


FDA/OMPT/CDRH/OCER/DFOI/ 


2012-7351 

10/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-5751 

11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-7352 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-2638 

2012-7353 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-3213 

2012-7354 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-5728 

2012-7355 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-2920 

2012-7356 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-3057 

2012-7357 

10/12/2012 
11/09/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

PAUL  W  TRIPP 
LINCARE  INC 

FLEXLIFE  HEALTH  INC  (ZIN  MEDICAL  INC),  OH  -  EIRS,  483S, 
WARNING  LTRS  1/05  TO  PRESENT 

2012-7358 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-3296 

Page  30  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7359 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

201 2-3494 

L—\J   1  C—    O    I  \J  1 

2012-7360 

L—\J  1  C—     1  uuu 

10/12/2012 
11/09/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

BOOT,  KEVIN 

EMBRIA  HEALTH  SCIENCES  LLC  ANKENY  IA  -  EIR  7/24/12 

1  1 V  1  1  '  1  11 1  \    1   1  l_  1  \  L_  1  1   1    \_j  V/  1  1  1  *J  Vw/  1  V/    1_  l_  V/  ,    /  V 1  *J  1  V  1—  1  >l   1  ■    1 1  \        \  III    /  /  L—^Tf    1  C— 

2012-7361 

10/12/2012 

1  \JI    1  C—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  L-f  1    VwX  1/ 

WILLIAM  A  OLSON  PHD 

V  V  II  1  l/VIVI  1  \  V/I-VJV/I  >l   1    1  11— 1 

Center  for  Requlatory  Services,  Inc. 

FOI  DAILY  LOG  9/17-21/12 

1    Vw/ 1    l_/  /  VI 1       1     Lv/M    V/  ill      L—  1  /    1  £_ 

2012-7362 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

FOI  DAILY  LOG  9/17-21/12 

2012-7363 

10/12/2012 

1  \JI    1  C—l  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  V  1  1          If    \  '  L/  1         1     1/   Vw/  III       /    1  '   1  L/  |  / 

PFIZER  -  VISINE  PURE  TEARS  APRVL  CLNCL  TRIAL 

1     1     1 L  l_  11         VI  \J  1  1  *l  1— —    1           1  1 1         1  l_  1  \  \  I V/   /  \  1     1  1  V  1—  ?    V/  1_  1  N  V/  1—     1  1  1 1 1  \  1  ^ 

11/09/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

EFFICACY  2005 

2012-7364 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

KENNETH  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  9/24-28/12 

2012-7365 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  9/24-28/12 

2012-7366 

L—\J    1   C—      1  \J\J\J 

10/12/2012 

1  V//    1  C—l  L—\J\l— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  9/24-28/12 

1    Vw/ 1    ]—//  \  1  L_  1     LVM    \J  1  C—   l     L_  V//    1  L_ 

2012-7367 

10/12/2012 

1  \JI   1  C—l  C—\J\C— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

BARBARA  JONES 

1  '  1      \  1       l  l— *  1      \  1       l  I      \      \J  Vw/  1     *J    1   \_) 

DOMINION  GROUP  INC 

FOI  DAILY  LOG  9/17-21/12 

1    Vw/ 1    l_/  /  VI  1       1     L_  Vw/  V^/    \JI    \  i     C—  1  /    1  £- 

2012-7368 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOI  REQUESTS  9/10-14/12 

2012-7369 

t—\J  1  c—    1  \J\J\J 

10/12/2012 

1  \JI   1  £-/  £_*J  1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1— /  1  L/  1  / 

S  TIRUVENDRA 

\J  .     1  1 1  l  VJ  VI  IN  !_/  1  I  /\ 

RA  CHEM  PHARMA  LTD  ANDHRA  PRADESH  INDIA  -  EIR 

i  1 1  \  \j i  ii  i vi  I    i  ini  1 1 vi^v  I  I  ]—/  j  ni  v  ]—/ 1  1 1  i/  \  I    I  i /  \ i— / 1  vJ  i  i ,  1 1  n  i—i  in      i  1 1  i 

11/09/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

RA  CHEM  PHARMA  LTD 

3/26/1 2  TO  4/3/1 2 

2012-7370 

10/12/2012 

1  W/  1  C—l  £—\J  1 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  V//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  vJ/\    1  r\l  11  11  vjv_/l  >J             1  1 1  l/\l  V  1  1 

CanReg,  Inc. 

CLOSED  FOI  REOUESTS  9/24-28/12 

Ul  Vw/ V/  1  ,  \—t    1    KJ  1    1  1 1  VX  VJ  1  V/  1  VJ    \JI  L—^    C—KJI    1  L— 

2012-7371 

10/12/2012 

1  \JI    1  C—l  C—\J   1  L — 

11/09/2012 

FDA/OC/OES/DFOI/ 

1  1— '  /  V  V/  V//  V/  1—  V-//  1— /  1    VwX  1/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOI  REQUESTS  9/24-28/12 

2012-7372 

10/12/2012 
11/09/2012 

CVM/OCD/ 
0C/0ER/0PA/ 

THOMAS  E.  SOULE 

EDELMAN  COMBS  LATTURNER 

CANADIAN  BRAODCASTING  CORP  INVESTIGATION  OF 
IMPORTED  CHICKEN  JERKY  USED  AS  PET  FOOD 

Page  31  of  895 


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Total  Records:  9990 


\_/Ul  ill  Ul  TT 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  ricLIUtJoLci 

OUUJtfOl 

OC/OEXA/OPA/ 

ET  AL 

2012-7373 

10/12/2012 

1  \JI    1  L—l  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1 V  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

mahlana  natpl 

NDA  017871  -  SBA 

11/09/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PATEL,  MAHLAQA 

2012-7374 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOI  REQUESTS  9/24-28/12 

2012-7375 

10/12/2012 

1  \JI   1  L—l  C—\J  1  C 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    VJ r\l  V_/\_//  Vw/ 1 — O/  1— /  1  V_/  1/ 

FOI  Services,  Inc. 

CLOSED  FOI  REOUESTS  9/24-28/12 

Vw/ 1  V_/W  1  1  '    1    V_/  1    1  1 1  V_x  Vw^  1  ij  1  U    v//  C—'-T    L—\Ji    \  C— 

2012-7376 

10/12/2012 

1  \JI    1  L—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

L_j  V  V_/  1  1  1  1  VI    Vw/    1  1 1  \  1   11  1 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOI  REQUESTS  9/24-28/12 

Vw/ 1_ Vw/  Vw/ 1_  i_/  i   \  '  i  i  1 1  v_x  \j  i— _  v_j  i  v_j  v//  l     r  l  w    i  l  

2012-7377 

10/12/2012 

1  \JI     1  L—l  L—\J\L— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

i  i  vj/*   i  ni  ii  ii  \j  Vw-*  i  n  v/v/ 1  1 1  ir\i  vi  i 

CanReg,  Inc. 

CLOSED  FOI  REOUESTS  10/1-5/12 

V_/l  Vw/  Vw7  1  1  '    1    V_/  1    1  1 1  V_x  Vw^  1  ij  1  ij     1  \JI   A     \JI    A  C— 

2012-7378 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOI  REQUESTS  10/1-5/12 

2012-7379 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOI  REQUESTS  10/1-5/12 

2012-7380 

10/12/2012 

1  \JI    1  L—l  L—\J\C— 

11/09/2012 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

CLOSED  FOI  REQUESTS  10/1-5/12 

Vw/ 1— Vw/  Vw/  1  \—J    1    Vw/  1    1  1 1—  V_x  LJ  1  XwJ  1  V/     IV//    1     J/    1  L_ 

2012-7381 

10/12/2012 
11/09/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOI  REQUESTS  10/1-5/12 

2012-7382 

10/12/2012 
11/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

AYAMI MARUYAMA 
CANON  INC 

BARCO  -  MAMMO  TOMOSYNTHESIS  K1 03792;  CORONIS 
FUSION  10MP  K093197;  EIZO  -  REDIFORCE  RX840-MG 
K093197 

2012-7383 

10/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Laura  Jacques 

INFLUENZA  VACCINE  -  VAERS 

11/13/2012 

ALFB/ 

Jacques,  Laura  A 

2012-7384 

10/15/2012 
11/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

Andrew  Pollack 

NEW  YORK  TIMES  COMPANY 

NEW  ENGLAND  COMPOUNDING  COMPANY  -  MEETING 
MINUTES,  483,  REPORTS 

Page  32  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7385 

10/15/2012 

l  \JI  l  \JI  (—  \J  l  t— 

11/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS 1  \i  Vw/ 1  V  1  1      \l\J\—t\  11   1  /  W  \S  1  1  1/        1    Vw/  1  / 

Diwirl  Hwann 

Lfaviu  1  IVVQI  IU 

Mid-Link  International  Inc 

SHENZHEN  MINDRAY  BIO-MEDICAL  ELECTRONICS  CO 

<Sl   II  1  N  £—  1   II  IN    IVIIIML/I  l/  \  1     1  >  1  V/    Ivll  IS  1  V//  \  1       1  1  1  \S  1  1  I  \_/  1  >l  1  \_/  vj    V/  V  >  .  , 

LTD  -  483  (4/9/201 2  to  4/1 2/201 2) 

2012-7386 

10/15/2012 
11/13/2012 

OM/OMP/DODM/ 

Vw /  1  V 1/  V_/  1 V  1  1    /  \S  Vw/  i — '  1 V  1/ 

John  Oonnpll 

Uwl  II  1    Vw/v/l  II  Ivll 

John  Connell 

PETITIONS  RE  ARENA  PHARM  LORCASERIN  ONEXA 

i    i      ill  i  \s  i  n  \s  i  ii      i\  i  ii  i  Nr\  i    i  1 1  \  i  1 1  v  i  i  Vw/ 1  lunvji  i  ill       Vj<i  n  i  / v/  v 

2012-7387 

10/15/2012 
11/13/2012 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

David  O'Connor 

PRACS  INSTITUTE,  LTD. 

BA  RESEARCH,  HOUSTON,  TX  -  EIRS  (01/01/2005  - 
12/31/2005) 

2012-7388 

10/15/2012 

1  \JI  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \m/  L-/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

Saiian  Arval 

v/ cu J ct i  i  / v i  ym 

IWAKI  SEIYAKLJ  CO  LTD  KAKEGAWA  CITY  JAPAN  -  EIR 

1  V  V  I  \  1  \  1    \J  1  1   1  1  \  1  \  l_f    \J  Vw/    1      1  ]S  j    1  V/  V 1  \  1  Vw/  /  V  V  V  1  \   Vw/  II     1    ,    >J  /  V 1    /  V 1  Nl        1  111 

11/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  v  1  1          11   \  '  L/  1  1     1/   \w/  III       /    1  '   1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ACCUCAPS  INDUSTRIES  LTD 

10/08/2010 

2012-7389 

10/15/2012 
11/13/2012 

FDA/OC/OES/DFOI/ 

MOI,  Inc. 

RFQ  1 103834-SOL-2012  -  ARBEE  ASSOCIATES,  INC. 
PROPOSAL 

2012-7390 

10/15/2012 

1  \Jl    1  \JI  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  \S  1  1  1/  \s  III    /  IS  1  L-/  1  / 

Andrpw  firant 

I  \  1  1  vj  1  t7  V  V          1  CI  1  1  L 

ZYPREXA  RISPERDAL  -  ISR 

L      II     11 1  /  V/  \  .    Ill  \S  1  1— —  1  I  \S  I  \  l_        1  V/  1  1 

11/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1     IS  1  \!  \S  1  V  1  1       1  /  \w/  L*S  1       1    1/  \-S  III     /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Benten  Films 

2012-7391 

10/15/2012 

1  \JI    1  \JI  L—\J\S— 

11/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  11   1/  Vw/  V/  l_  1  1/  IS  1    Vw/  1/ 

Medinnovo  LLC 

K081 147 

1  V  \J  \J  1    1  *T  / 

2012-7392 

10/15/2012 
11/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Scott  Ki 

Idaho  Business  Review 

IBX,  CARDIOGRIP,  ZONA  PLUS,  ZONA  RX  -  51  OK 

2012-7393 

10/15/2012 

1  \JI    1  \JI  L—\J\S— 

11/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \J  IS  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Chri^tonhpr  Wpavpr 

' — '    II  IOIUUI  IUI     V  (C/CI  VCI 

THE  WALL  STREET  JOURNAL 

CANADA  DRUGS  CANADADRUGS  COM  -  FDA  CORR  RE 

\S  1  W  M  /  V  IS  1  \   IS  1  I  *s  V^/  V/  ^    V/  /  VI  N  /  \  1  '  1  \  1  '  1  I  V_/  V_/  V/  ■  Vw/  Vw/  1 V  1         1     L/  /  \   V/  V/  1  1 1  I    11 1  

9/21/12  WARNING  LETTER  ETC 

2012-7394 

10/15/2012 
11/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

1    IS  1  \!  Vw/  \J  1  l V-/  1    /  Vw/  1  1/ \/  V/  l__    1    Vw//  1  III 

DO/PHI-CB/ 

Alka  Ohandna 

niivci  \j\  icii  ivj i  id 

PETA 

TRIPLE  F  FARMS  SAYRE  PA  -  EMAILS  LETTERS 

i  i  1 1 1    i  i_  i     i  i  \  i  1 1  v  i  v/  *  v/  /  \  i  i  1 1— _ ,  i    /  \       i_  i  v  1 1  \  1 1—  v/  j  i_  i_  i    i  i_  i  i  \s  , 

REPORTS,  ETC 

2012-7395 

10/15/2012 

1  \JI  1  \JI  t—\J\i— 

11/13/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

1  1 — '  1  \!  Vw/  V/  1   1  V_/  1    /  V^/  1   It  \/  V/  l__    1    Vw//  / \  1  1  

DO/ATL-CB/ 

Roh  RijrnQ 

IS  w  V-j    IS  1/  1  1  1 0 

Talenti  Gelato 

JIMBO'S  JUMBOS  INC  EDENTON  NC  -  EIRS  M  0/01/2009  - 

\J  1 1 V  1  is}  V_/  U  VJ  V/  1 V  1  is}  V_/  v/  .    1 1  *l  V/  .  1— —  (_/  1  1  >J  1  Vw/  In.    IN  V/        l_  1  1  IO    I    1  v/  U  1  /  £_  V/  V/  v/ 

10/11/2012) 

2012-7396 

10/15/2012 

1  \Jl    1  \JI  L—\J\t— 

1 1/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  V/  1    ^/ /  \  1  Hi  Vw/  Vw/  L//  l_  Vw/  V// 

Silvia  Volkmann 

\J  1 1  V  1 CL    V  w  1  |\I  1  1  CI  1  1 1  1 

Orion  Engineered  Carbons  GmbH 

FAP  5B4464 

1   1  \  1      v/ 1—*  V/ 

2012-7397 

10/15/2012 
11/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Steve  Barwick 
Barwick,  Steve 

SILVER  CONTAINING  DIETARY  SUPPLEMENTS  -  RECS  RE 
ABSORBING  CERTAIN  DRUGS 

2012-7398 

10/15/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

ALMASED  -  RESPONSE  TO  01/18/12  WARNING  LETTER 

Page  33  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/13/2012 

DO/FLA-CB/ 

Schraven,  John 

2012-7399 

10/15/2012 
11/1  ^/?ni  ? 

1    1  /  1  Of  £.\J  1  C- 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Paula  Eichman 

APTAI      PHARMATFCH  INC 

r\ \     \  t\  1  1 0  1    1  1 1\  1  1 1 V 1  r\  \  \  w  1  1  1 1  M \j 

NATIONAL  VITAMIN,  CASA  GRANDE,  AZ  -  EIRS  LAST  TWO 
YEARS 

2012-7400 

10/15/2012 
11/13/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Amanda  E.  De  Vito,  Couch  White 
LLP 

Couch  White  LLP 

SICAP  INDUSTRIES,  LLC,  ALBANY,  NY;  GSC  PRODUCTS 
LLC,  ALBANY,  NY;  WAYNE  PERRY  -  RECS  01/01/03  TO 
10/11/12 

2012-7401 


2012-7402 


10/15/2012 
11/13/2012 


10/15/2012 
11/13/2012 


FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 
ORA/OCI/ 

ORA/OCI/  

FDA/OMPT/CDRH/OCER/DFOI/ 


ROBERT G  BERNHOFT 
BERNHOFT  LAW  FIRM  SC 


BRANT  WIGGER 
TRANSPHOTON  CORP 


INDIVIDUAL  RECS 


APEX  XL-4  K033001 


2012-7403 


2012-7404 


2012-7405 


10/15/2012 
01/31/2013 

10/15/2012 
11/13/2012 


10/15/2012 
11/13/2012 


FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/  

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 


LAWRENCE  A  BOHM  ESQ 
BOHM  LAW  GROUP 

ROBERT  E  COLLIER  II 

COLLIER  &  ASSOCIATES  LAW 
OFCS 

MARTIN  R  PRINCE  MD  PHD 

Weill  Medical  College  of  Cornell 
University 


INDIVIDUAL  RECS 


TEVA  PHARMACEUTICALS  USA,  TEVA  NEUROSCIENCES 
INC  -  COPAXONE  CMPLNTS,  RVWS,  AERS,  ETC 


GADOLINIUM  -  ISRS  6055003,  6238473,  ETC 


2012-7406       10/15/2012  FDA/OMPT/CDER/ORP/DIDP/ 
1 1/1 3/201 2  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


DOUGLAS  P  DOWD 
DOWD  &  DOWD  PC 


ABBOTT  LABS  -  DEPAKOTE  (DIVALPROEX  SODIUM, 
VALPROIC  ACID)  AERS,  WARNINGS,  CO  RESP,  ETC 


2012-7407 


2012-7408 


10/15/2012 
11/13/2012 

10/15/2012 
11/13/2012 


FDA/OGROP/ORA/ORO/DIOP/ 

FDA/OGROP/ORA/SW- 
FO/SWID/SWID-CB/  

ORA/OCI/ 

ORA/OCI/ 


CLAUDIA  HORNBACK 
ROANOKE  TRADE  SERVICES  INC 


Doe  J 


AGROSUN  INC  -  ENTRY  #DV1 01 281 900  NOTICES  OF  FDA 
REFUSAL 


INDIVIDUAL  RECS 


2012-7409 


10/15/2012 


FDA/OC/OES/DFOI/ 


MEGHAN  E  RUESCH 


USA  FAR  OCEAN  GROUP  INC  -  U-PROSTA  NATURAL 


Page  34  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/13/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TRAUB  LIEBERMAN  STRAUS  ET 
AL 

SUPPORT  FOR  PROSTATE  HEALTH  CORR,  WARNING  LTRS, 
CMPLNTS,  ETC 

2012-7410 

10/15/2012 
11/13/2012 

FDA/OC/OES/DFOI/ 

ALISON  M  AGNEW 

PILLSBURY  WINTHROP  SHAW 
PITTMAN  LLP 

2012-6833 

2012-7411 

10/15/2012 
11/13/2012 

FDA/OC/OES/DFOI/ 

JOHN  H  REED  MD 

WORLD  INSTITUTE  FOR 
SCIENTIFIC  EXPLORATION 

FOI  DAILY  LOG  FY  1966  TO  FY  1999 

2012-7412 

10/15/2012 
11/13/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

CRAIG  ROUSH 
ROCKLINE  INDUSTRIES 

KLEEN  TEST  PRODUCTS  CORP,  PORT  WASHINGTON,  Wl  - 
EIR,  483,  CORR  8/12 

2012-7413 

10/15/2012 

1  \JI  1  \JI  t—\J\i— 

11/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  1  \l  Vw/  1 V  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  \—s  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DOUGLAS  P  DOWD 

i— /  Vw/  v/  \j  i— / \v/  i     l/  Vw/  v  v  i — - 

DOWD  &  DOWD  PC 

HOFFMAN-LAROCHE/ROCHE  LABS  -  ACCUTANE  AERS 

1   1  Vw/  1    1    1  v  1 1  V 1  VI    1  1  \  1   IV/VJ  1   1  1  /  1  I  Vw/  \_J  I   I  1        l_/ V I  >  \_j        f\  Vw/  Vw'  V/  1  / \  1  v]  1       1  V  l_  1  l  v/  . 

WARNINGS,  CO  RESP,  ETC 

2012-7414 

10/15/2012 

1  \Jl    1  \JI  t—\J  1  £_ 

11/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  \w/  1    /  w  1    v//\  1  N/  Vw/  Vw/  1 — /  /  l_  Vw/ \Jf 

HALEY,  KALA 

FREE  RANGE  CAGE  FREE  ANIMAL  PRODS  -  DEFINITIONS 

1        1     l  1         1             1     l  /    \  1   V|  Vwl  1         J      Vw/  / \  Vw^  1             III  l_  l_     1    \  1   V|  1  1  V  1  /    \  1            1        1     I  Vw/  L/  Vw/              Iw/  1         1        1  1    il  1     |     |  Vw/  1    V]  Vw/  , 

VIOLATIONS,  FALSE  ADVERTISING,  ETC 

2012-7415 

10/15/2012 
11/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

STUTE,  HANK 

CPT1200119 

2012-7416 

10/15/2012 
12/06/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

JOHN  RICHARSON 
Surveyor  Capital 

BAXTER  HEALTHCARE  CORP-BAXTER  AG  1/21/10;  BAXTER 
BIOSCIENCE  1/28/10;  BAXTER  MANUFACTURING  SPA  9/1/09, 
ETC  -  483S 

1 —  1  Vw/       "  V/  O  O 

2012-7417 

10/15/2012 

1  \JI  1    '/  t—\J\i— 

11/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          1  '  1      \l     Vw/  |  V  1   1             1     /    \m/  L- /   1       11       1/    *^-/  \w /  l_  |       1/     1  /   |         Vw/  J/ 

John  Rlpwitt 

\J  \J  1  1 1  1    1  1 1  \j  V  V  1  L  L 

LIFECELL  CORPORATION 

K080442 

2012-7418 

10/16/2012 

1  \JI     1  \JI  L—\J\l— 

11/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    J  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  11   1/  Vw/ \J  1—  1  1/  1  /  1    Vw/  1/ 

Rprnita  Virk 

Uvl  1  1  1  LCI     V  lv^l\ 

MPR  Associates,  Inc. 

K0 12769 

1  V  V/  1  £_  /  \J  \J 

2012-7419 

10/16/2012 
1 1/14/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Judy  Negley 
Val^nar  Oornoration 

FCN  1103 

2012-7420 

10/16/2012 

ORA/ 

Richard  R.  Stephens 

TEST  RESULTS 

11/15/2012 

ORA/ 

FDA/OGROP/ORA/SW-FO/DAL- 

Stephens,  Richard  R 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

DO/DAL-CB/ 

2012-7421 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ONCASPAR - AERS 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Lee,  Ellese  N 

2012-7422 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/ORO/DIOP/ 

THE  NEW  YORK  TIMES 

OASIS  DATA 

2012-7423 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

LYNN  R  WEBSTER,  SALT  LAKE  CITY,  UT  -  MOST  RECENT 
483 

2012-7424 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Kathy  Takeuchi,  Pharm.D. 

HYDROXUREA - AERS 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HARBORVIEW  MEDICAL  CENTER 

2012-7425 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

Connie  Romaine 

LSU  Health  Sciences  Center  in 
New  Orlean 

LSU  HEALTH  SCIENCES  CENTER,  NEW  ORLEANS,  LA  - 
RESPONSE  TO  LETTER  DATED  06/29/12 

2012-7426 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PRADAXA  -  AERS 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

KMGH-TV 

2012-7427 

10/16/2012 
11/14/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Bethany  Walls 
INTERTEK 

FCN  1167 

2012-7428 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SE-FO/SJN- 
DO/SJN-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

ACCURAY  INC,  SUNNYVALE,  CA;  MEDTRONIC  ADVANCED 
ENERGY  LLC,  PALO,  ALTO,  CA;  SKELETAL  KINETICS  LLC, 
CUPERTINO,  CA,  ETC  -  483S  7/1-31/12 

2012-7429 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SE-FO/SJN- 
DO/SJN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

WYETH  PHARMACEUTICAL  CO  (PFIZER  CONSUMER 
HEALTHCARE),  GUAYAMA,  PR;  ABBOTT  BIOTECHNOLOGY 
LTD,  BARCELONETA,  PR;  SURGICAL  SPECIALTIES  PUERTO 
RICO  INC  (ANGIOTECH  PR  INC),  AGUADILLA,  PR  -  483S  7/1- 
31/12 

2012-7430 

10/16/2012 
11/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Huan  Tran 

Next  Orthosurgical,  Inc. 

K1 02694 

2012-7431 

10/16/2012 

FDA/OC/OES/DFOI/ 

Sarah  Freishtat 

MEDIA  FOIA  REQUESTS  LAST  SIX  MONTHS 

Page  36  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/14/2012 

MEDILL  SCHOOL  OF 
JOURNALISM 

2012-7432 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

VIDCO  INC,  BEAVERTON,  OR;  KOREGON  ENTERPRISES  INC 
(NITE  TRAIN'R),  BEAVERTON,  OR;  ATOSSA  GENETICS  INC, 
SEATTLE,  WA,  ETC  -  483S  7/1-31/12 

2012-7433 

10/16/2012 

1  \JI  1  \JI  (—  w  1  fc. 

11/14/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Trppv  Tavlor 
i  i  uoy  i  ay 

Tracy  Taylor 

ROCHE  CAROLINA  FLORENCE  SC  -  EIR  48^03/01/2012- 
10/01/2012 

2012-7434 

10/16/2012 
11/14/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

BAXTER  MANUFACTURING  SPA,  RIETI,  ITALY  -  483S  7/1- 
31/12 

2012-7436 

10/16/2012 
11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \w/  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JOHNATHAN  RICKMAN 

\J        1   IIM/^  1  1   ir\l  M    1  1 1  \J  1  \l  Vl/^l  N 

FDA  NEWS 

HISUN  PHARMACEUTICAL  HANGZHOU  CO  LTD  FUYANG 

1   1 1  O  \~r  1  M    1     1   Inl  1 1 V 1  Vw^  1   1  W/\  1       1   1 1  \  1  M             1    1  KJ\J    \J\*r    1      1  !_/  ,    1            1  1  \  1  >J  V  ^ 

CITY,  CHINA;  ALCHEM  INTERNATIONAL  LTD,  BALLABGARH, 
FARIDABAD,  HARYANA,  INDIA;  CENEXI  LABORATORIES 
THISSEN  SA,  BRAINE  L'ALLEUD,  BELGIUM,  ETC  -  483S  7/1- 
31/12 

2012-7436 

10/16/2012 
11/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

TAIWAN  KING  STRONG  CO  LTD,  TAICHUNG  CITY,  TAIWAN; 
XIANTAO  RAYXIN  MEDICAL  PRODUCTS  CO  LTD,  XIANTAO 
CITY,  CHINA;  VBM  MEDIZINTECHNIK  GMBH,  SULZ  AM 
NECKAR,  GERMANY,  ETC  -  483S  7/1-31/12 

2012-7437 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

BLOOMEX  INTERNATIONAL  INC,  ELMWOOD  PARK,  NJ; 
INTEGRA  LIFESCIENCES  CORP,  PLAINSBORO,  NJ  -  483S 
7/1-31/12 

2012-7438 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

SUNBEAM  PRODUCTS  INC  (JARDEN  CONSUMER 
SOLUTIONS),  WAYNESBORO,  MS;  SOURCE  PRODUCTION  & 
EQUIPMENT  CO  INC,  ST  ROSE,  LA;  KNU  LLC,  LELAND,  MS  - 
483S  7/1-31/12 

2012-7439 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

GENZYME  CORP,  FRAMINGHAM,  MA;  TWINCRAFT  INC, 
WINOSKI,  VT;  SPECIALTY  MINERALS  INC,  ADAMS,  MA,  ETC 
-483S  7/1-31/12 

2012-7440 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CORE  LABS  LLC,  ENGLEWOOD,  CO  -  483S  7/1-31/12 

2012-7441 

10/16/2012 
1 1/14/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

JOHNATHAN  RICKMAN 

i — r~\  A  Nil — 1  A  /o 

FDA  NEWS 

NATURAL  ESSENTIALS  INC,  STREETSBORO,  OH;  AMYLLIN 
OHINO  LLC,  WEST  CHESTER,  OH;  SCOTTCARE  CORP, 
CLEVELAND,  OH  -  483S  7/1  -31/12 

2012-7442 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

PRIMROSE  CANDY  CO,  CHICAGO,  IL;  ABBOTT  MOLECULAR, 
DES  PLAILNES,  IL;  HOSPIRA  INC,  LAKE  FOREST,  IL  -  483S 
7/1  -31/12 

2012-7443 

10/16/2012 
11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

KEVIN  M  FITZERLAND 
LEWIS  SAUL  &  ASSOCS 

ORTHO  PHARMACEUTICAL,  CORP;  ORTHO-MCNEIL 
PHARMACEUTICALS  INC;  PRICARA,  ETC  -  LEVAQUIN 
AERS,  TRANS,  LTRS,  ETC 

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Total  Records:  9990 


/"V  1  1  It 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

OM/OMP/DODM/ 

2012-7444 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

KEVIN  M  FITZGERALD 

SCHERING-PLOUGH  CORP;  SCHERING  CORP;  MERCK  & 

11/1 4/2012 

1     1  /    1     It  L—  V/   1  L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  1  \i  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V-/  III    /  l_/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
OM/OMP/DODM/ 

LEWIS  SAUL  &  ASSOCS 

CO  INC  -  AVELOX  AERS,  TRANS,  LTRS;  ETC 

2012-7445 

10/16/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

JOHNATHAN  RICKMAN 

BRISTOL  MYERS  SQUIBB  CO,  EAST  SYRACUSE,  NY; 

11/14/2012 

DO/NYK-DCB/ 

FDA  NEWS 

MOGEN  INSTRUMENTS,  BROOKLYN,  NY;  SMARTPILL  CORP, 
BUFFALO,  NY -483  7/12 

2012-7446 

10/16/2012 

FDA/OGROP/ORA/CE-FO/BLT- 

JOHNATHAN  RICKMAN 

VIRGINIA  BLOOD  SERVICES,  RICHMOND,  VA  -  483  7/12 

11/14/2012 

DO/BLT-CB/ 

FDA  NEWS 

2012-7447 

10/16/2012 

1  \JI  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  l_/  I  / 

.lu^tinp  Hanpr 

uuoui  ic  i  iciytji 

NDA  018780 

1 1/14/2012 

1     1  /    1  TV  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1 1      1  /  V_/  l_/  |  |  1/  V_/  III    /  [_/  |  L-f  |  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Rinrlpl  Inr* 

1  '  1             1    II  ll_i. 

2012-7448 

10/16/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

JOHNATHAN  RICKMAN 

BANNER  PHARMACAPS  INC,  HIGH  POINT,  NC;  NEWTON 

11/14/2012 

DO/ATL-CB/ 

FDA  NEWS 

LABORATORIES  INC,  CONYERS,  GA;  CR  BARD  INC, 
COVINGTON  GA  -  48T  7/1 2 

2012-7449 

10/16/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 

JOHNATHAN  RICKMAN 

POLYMER  TECHNOLOGY  SYS  INC,  INDIANAPOLIS,  IN; 

11/14/2012 

DO/DET-CB/ 

FDA  NEWS 

AXIOBIONICS  LLC,  ANN  ARBOR,  Ml  -  483  7/12 

2012-7450 

10/16/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

JOHNATHAN  RICKMAN 

ATLANTIC  PRO  NUTRIENTS  INC,  ORLANDO,  FL;  DEXTRUM 

a  a   '  a   A  'r\r\  a  r\ 

1 1/14/2012 

DO/FLA-CB/ 

FDA  NEWS 

LABORATORIES  INC,  MIAMI,  FL;  ADVANCED  RADIATION 

MEASUREMENT  INC,  FT  PIERCE,  FL  -  483  7/12 

2012-7451 

10/16/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

JOHNATHAN  RICKMAN 

AUXILIUM  PHARMA  INC,  HORSHAM  ,  PA;  PARTICLE  SIZE 

11/14/2012 

DO/PHI-CB/ 

FDA  NEWS 

TECHNOLOGY  INC,  QUAKERTOWN,  PA;  HERCON 

LABORATORIES  CORP  EMIGSVILLE  PA -483  7/1 2 

1  1  \ i—J Vw/ 1  1 1  \  I  Vw/ 1  1 1 1  vj  V*/  v_/  ill    ,  I  I V 1 1  vJO  V  II  1  1  ,  I    n      tUu  //lt_ 

2012-7452 

10/16/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

JOHNATHAN  RICKMAN 

MARCUS  RESEARCH  LAB  INC,  ST  LOUIS,  MO  -  483  7/12 

11/14/2012 

DO/KAN-CB/ 

FDA  NEWS 

2012-7453 

10/16/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

JOHNATHAN  RICKMAN 

HEALTH  PLUS  INC,  CHINO,  CA;  LEVLAD  LLC, 

A  A    I  A    A  lr\r\  A  r\ 

1 1/14/2012 

DO/LOS-CB/ 

FDA  NEWS 

CHATSWORTH,  CA;  BLAINE  LABS  INC,  SANTA  FE  SPRINGS, 
CA-483  7/12 

2012-7454 

10/16/2012 

FDA/OGROP/ORA/CE-FO/MIN- 

JOHNATHAN  RICKMAN 

WISCONSIN  PHARMACAL  CO  LLC,  JACKSON,  Wl;  KLEEN 

11/14/2012 

DO/MIN-CB/ 

FDA  NEWS 

TEST  PRODUCTS  CORP,  PORT  WASHINGTON,  Wl;  AJD 

LABORATORIES  INC,  PARK  RAPIDS,  MN  -  483  7/12 

2012-7455 

10/16/2012 

ORA/ 

JOHNATHAN  RICKMAN 

TAKEDA  PHARMACEUTICAL  CO  LTD,  HIKARI,  JAPAN  -  483 

11/14/2012 

ORA/ 

FDA  NEWS 

7/12 

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Total  Records:  9990 


V_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  laLUl  u/  nULIUtJoLci 

OUUJtfOl 

FDA/OMPT/GDFR/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  W  L/  1  1  1/  W  III    /  L/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  1  \i  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  \y  III    /  l_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7456 

10/16/2012 
11/14/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  9/10-14/12 

2012-7457 

10/16/2012 
11/14/2012 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    i  '  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V_/  III    /  1— /  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Riip  Cnrhptt 

THE  RESEARCH  INVESTMENT, 
INC. 

GUIDANCE  CONJUGATED  ESTROGEN  TABLETS  -  IN  VIVO 

1  L/ 1  \  1  N  W  1        \J  V_/  1  NlJ  \J  \^AI  \  1  1  L/    1  w  1  1  1  Vw/       1  1  M     1  1  \  L/  1  1       1  \J        1  1  M     V  1  V  Vw/ 

BIOEQUIVALENCE,  IN  VITRO  DRUG  RELEASE 

2012-7458 

10/16/2012 

1  V//   1  V//  t—\J\l— 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

John  Ronifipld 
CNN 

EPIDURAL  INJECTION  OF  NECC  PRODUCT  -  DATE  OF 

1  1     1  1  /  \m/  1  1 1  \  l_    1  1  *J  i_J  1  Vw/  1  1  V^/  1  M    V/  1      1  M  1  V/  V/    1     II V*/  I — '  V/  V/  1  1 — /  /  V  1  1        Vw/  1 

EXPOSURE,  NAME  AND  LOCATION  OF  FACILITY; 
TRANSPLANT  PATIENTS  -  DATES  OF  EXPOSURE,  NAME 
AND  LOCATION  OF  FACILITIES 

2.0  \  ^-7459 

10/16/2012 
11/14/2012 

rUA/UIVIr  1  /OUKH/UOtK/UrOI/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

K0o^298 

2012-7460 

10/16/2012 

1  \JI   1  V//  £-V/  1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/ 1  \l  Vw/  1 V  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  L/  1  l_/  1  / 

Annplia  Slavtnn 

ni  ly  \d  \  \  ex.  \j  i  ci  y  iui  i 

NDA  21520  S  012 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-7461 

10/16/2012 

1  V//   1  V//            1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

.lu^tinp  Hanpr 

uuoui  i v/  i  lau&i 

NDA  020928 

1  ML//  V  v/  £_  \J  \J  L—  V/ 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Biodel  Inc. 

2012-7462 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  \—S  1  L/  1  / 

.lu^tinp  Hanpr 

uuoui  i vz  i  lau&i 

NDA  018780 

1  M  L/  /  \   V/  1  V/  /  V/ \J 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  I — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Biodel  Inc. 

2012-7463 

10/16/2012 
11/14/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

Susan  Searles 
IKARIA  INC 

AVANTOR  MATERIALS,  CENTER  VALLEY,  PA  -  EIR 
(01/03/2011  -  10/16/2012} 

2012-7464 

10/16/2012 
11/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M.  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 

K963226,  K931386,  K915774 

Page  39  of  895 


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MEDICINE 

2012-7465 

10/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M.  ARDAUGH 

K831949,  K923367,  K926138 

11/14/2012 

NORTHWESTERN  UNIV 

FEINBERG  SCHOOL  OF 

IVItUIUHNt 

A  A  H  A  ~I ACC 

,£-7466 

^  a  /^    /aa  ■(  o 

10/16/<;01<i 

rUA/OMr  I  /OUKH/UOtK/UrOI/ 

nni —  NIT"  h  A     AnnAI  |AU 

BKtN  1  M.  AKUALKjH 

l/AOO  H  A  ^ 

K083191 

4  H  /-<  yl  /A  A  ■(  A 

11/1 4/<;01 2. 

MADTUl  MCPTC  DM  1  IMIW 

NUK  1  HWtb  1  tKN  UNIV 

FEINBERG  SCHOOL  OF 

1    1—  1  1  N  1  t  1  1  I  \J    \-J  \J  1   1  Vw/  Vw/  1_  Vw/  1 

MEDICINE 

2012-7467 

10/16/2012 

ORA/ 

BRIAN  HARTMAN 

SUNLAND  INC  -  SALMONELLA  OUTBREAK  2007  TO 

11/14/2012 

ORA/ 

ABC  NEWS 

PRESENT 

2012-7468 

10/16/2012 

FDA/OGROP/ORA/SW-FO/DEN- 

INDIVIDUAL  RECS 

11/14/2012 

DO/DEN-CB/ 

Doe  J 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7469 

10/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PFIZER  -  LYRICA  AER 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

NICOLAS  635504,  ALBERT 

FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UMr  I  /OUtrl/Urir/UlUr/ 

2012-7470 

10/16/2012 

FDA/OC/OES/DFOI/ 

1  1— '*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

KENNETH  REID 

1  \  1—  1  il  1  il  l__  1  1   1    1  1 1  1  L/ 

FOI  DAILY  LOG  10/1-5/12 

1    Vw/  1  1— / /  V 1  L_  1     L_  Vw/  V^l     1  \JI   1     \J1    1  L_ 

1 1/1 4/^iUI  iL 

W/ACUIMPTOM  IMCHDKilATinM 

vVAonlNo  1  UN  INrUnlVIAI  IUN 

SOURCE 

2012-7471 

10/17/2012 

FDA/OC/OES/DFOI/ 

Paul  Knoepfler 

CELLTEX,  SUGARLAND,  TX  -  WARNING  LETTER 

11/15/2012 

UNIVERSITY  OF  CALIFORNIA, 

DAVIS 

2012-7472 

10/17/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Mark  Jackson 

FCN  1096 

11/15/2012 

ARCADIS 

2012-7473 

10/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Johnathan  Rickman 

HOLOPACK,  GERMANY  -  483  2/24/2012 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA  NEWS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7474 

10/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

K101382 

11/15/2012 

Imran  Karim 

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2012-7475 

10/17/2012 

1  \JI  1  /  /  (—  w  1  fc. 

FDA/OF/CFSAN/OCD/EOS/ 

ncpoRT  BY  FDA  TO  HHS  RE  LABELING  OF  INFANT 

1  11  1     Vw/  1  1  1       LJ  1     1    L/ 1  \     1  Vw/    1   II   1  vJ    1  11        L  /  V 1  1 1  1  II^IVul    V_/  1       1 1  VI 1    /  V 1  >J  1 

^/4r  /OA  ^  O 

Wheeler,  Lisa  r 

FORMULA  1981 

201 2-7476 

H  O  1 H  ~7  /O  O  H  O 

10/17/2012 

rUA/UuKOr/UKA/NE-rU/NWE- 

Drew  Barlow 

\  / 1 —  n~r  i —  v/  ni  i  a  n  r  a  i  k  i          f~\  An.  i —  i  n  ho  /o  h/hh  oh  /ho/ho 

VERTEX  PHARM  INC  -  QAP;  EIR  12/21/1 1-01/13/12 

H  H  /H  C  /OO  H  O 

1 1/15/2012 

DO/NWE-CB/ 

Vertex  Pharmaceuticals 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1— /  1  i  /  1  / 

Inrnrnnratpd 

1  1  1  v-/ V/ 1  L/ V/  1  Ci  l  t7VJ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      11  W  l_/  1  1  1/  W  III    /  [_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7477 

10/17/2012 

1  VJ/  1  /  /  C\J  1  £_ 

ORA/ 

\JCKl  1  1  C7o  1  \ \  lul  cvvo 

SLJNLAND  INC  -  INSPECTION  RECS  0^/01/2009  -  10/1R/2012 

\J      1  >J  1  nl  >J  \—J  ,    1 1  VI  \J       1 1  VI  v  '  1    1  \J  1  1  Vw/ 1  N    1  1 1  \J \J  \J\Jl  \J  1  /  L_UU  J         1  \JI  1  V//           1  L 

11/15/2012 

ORA/ 

FOOD  SAFETY  NEWS 

2012-7478 

10/17/2012 

1  \JI   1  /  /  t—\J  1  £_ 

ORA/ 

Chprvl  Rprn^rd 

\  '  1  1  \j  \  y  1    1  /  v/ 1  1  1  CI  1 

SUNLAND  INC  -  EIR  483  RESPONSES  08/01/2009  - 

Vw^  \*J  1  *J  1  /  VI  *J  1 — /    1  1  *J  Vw/        l_  II   1  1      r  L/  O  ,11 1_  O  1  Vw /  1  N  V/  1— —  V/   V/  C/  V/  11  £—  V/  V/  *_/ 

11/15/2012 

ORA/ 

Bernard,  Cheryl 

10/16/2012 

2012-7479 

10/17/2012 

1  \JI    1    /  /  L-\J  1  £_ 

FDA/OF/CFSAN/OCD/EOS/ 

Mark  .lapk^nn 

ivicii  rv  kj  uuixoiji  i 

FCN  1021 

1    Wl  N     1  \J  C—  1 

1  CI  C\Jl  C\J  I  c 

ARHADIS 

nnonu  I  o 

2012-7480 

10/17/2012 

1  \JI  1  /  /  C\J  1  c 

FDA/OF/CFSAN/OCD/EOS/ 

Mark  .lapkeinn 

ivicii  rv  uuuixjui  i 

FCN  1020 

1    \J  1  N     1  \J  C—\J 

11/15/2012 

ARCADIS 

OfH  O  7/1J31 
£iU  1 1^-  /  1 

in/1 7/oni  o 

e  n  a  /Pi  Pi  ir\  p  r  a  /Pi  a   q  / 

r  UM/UU/UrDM/UnuO/ 

uuicpootjoni 01  nnoo.1    dp^phcai    AWAnncn  phmtdapt 
MnoriiiiOiiUl  eL\  UU^yi  -  rnUrUoAL,  AVVAnUtU  UUIN  I  nAu  I  , 

11/15/2012 

Strategi  Consulting 

MODIFICATIONS 

1 V  1  Vw/  1  /  1  1     1  Vw//%  1  1  Vw/  1  N  V_J 

2012-7482 

10/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Gary  Pekoe,  Phd.,  or  Kelley 

PLUROGEL  45-5  CONCENTRATE  CLEANSING  PRODUCT  - 

11/15/2012 

Orpampr  Rpnulatnrv  Affairs  Mnnr 

\j i  ccii  i  ici  .  i  icy u i ci l v/ 1  y  n 1 1 cii i  o  ivn  iui 

DEVICE  CORR 

L/  1       V  1  V/  1— —    v/  Vw/  1  1 1  I 

PluroGen  Therapeutics,  Inc. 

2012-7483 

10/17/2012 

FDA/0GR0P/0RA/PA-F0/L0S- 

ALERE,  SAN  DIEGO,  CA  -  RESPONSE  TO  483  7/17/12 

11/15/2012 

DO/LOS-CB/ 

LEERINK  SWANN  &  CO 

2012-7484 

10/17/2012 

1  \Jl    1    /  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  Vw/  III    /  L-/  1  1—/  1  / 

Rnh  Di^plkamn 

1  1 V/  k/    L/IOOCI[\QI  1  IkJ 

RISPERIDONE  -  AERS 

111  \J  1  1— —  1  l  1  1  /  Vw/  1  M  l_        I  \  l_  1  I V/ 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Rob  Disselkamp 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7485 

10/17/2012 

1  \JI    1    /  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  > — /  III    /  l_/  1  !_/  1  / 

Rnh  Di^^plkamn 

1  1 V/  k/    L/IOOCI[\QI  1  Ik/ 

DEPAKOTE  - AERS 

1  /  1  1     /  \  1  V  Vw/  1  1            /  \  l_  1  l  K-f 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Rob  Disselkamp 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1   If  V_/  III    /  L/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7486 

10/17/2012 

FDA/OC/OES/DFOI/ 

AMY  KINCANON 

2009-8268 

11/15/2012 

LEXIS  NEXIS  COURTLINK  INC 

2012-7487 

10/17/2012 

FDA/OC/OES/DFOI/ 

AMY  KINCANON 

2010-2408 

Page  41  of  895 


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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/15/2012 

LEXIS  NEXIS  COURTLINK  INC 

2012-7488 

10/17/2012 
11/15/2012 

FDA/OC/OES/DFOI/ 

AMY  KINCANON 

LEXIS  NEXIS  COURTLINK  INC 

2010-8869 

2012-7489 

10/17/2012 
11/15/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

155879  -  CAERS  ADDITIONAL  RECS 

2012-7490 

10/17/2012 
11/15/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

155912  -  CAERS  ADDITIONAL  RECS 

2012-7491 

10/17/2012 
11/15/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

155912  -  CAERS  ADDITIONAL  RECS 

2012-7492 

10/17/2012 
11/15/2012 

FDA/OF/GFSAN/OOD/EOS/ 

a  iv  i  f**  i —  i   a  ou \/~r i_i 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

h  rrn"7A     /~\  a  i —  no  Ann  i  ~r~  i  /~\  k  i  a  i    n  i —  o 

155879  -  OAERb  ADDITIONAL  RECb 

2012-7493 

10/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       1  '  1    \i   \w/  |  V  1  1           1    /   \w/  L/  1     11      1/    V_/  \w /  l_  |     1/    1  /  |       Vw/  J/ 

MARY  BETH  HENDERSON 

i  vin  i  i  i    i  1 1__  i  i  i  i  1 1  i  *j  i — *  \  i  i Vw/ Vw/ 1  ii 

THERMOCHEM-HT  SYS  -  K993330 

i  i  1 1  i  1 1  v  i  w  Vw/ 1  1 1__  i  v  i   ill    \j  i  \j       i  \  j  \»y  v/  v/  v/  v/ 

11/15/2012 

FDA/OC/OES/DFOI/ 

RCRI 

2012-7494 

10/17/2012 
11/15/2012 

FDA/OC/OES/DFOI/ 

HENRY  GLUCKSTERN 
HENRY  GLUCK  ATTY 

SABIN  TRIVALENT  ORAL  POLIO  VACCINE  -  FOI  REQUESTS 
1/00  TO  PRESENT 

2012-7495 

10/17/2012 
1 1/15/2012 

1    1  /   1  \JI  C—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
CVM/OCD/ 

THOMAS  D  GOODRICH  PHD 
PHARMAO 

i    i  1 1  \ i  1 1 vinvx 

SHANGHAI  ZHONGXI  SUNVE  PHARMACEUTICAL  CO  LTD, 
SHANGHAI,  CHINA  -  EIRS,  483S  MOST  RECENT 

2012-7496 

10/17/2012 
11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  /  V/  Vw/ 1 V  1 1      1  /        L-/  1  1  1/  V_/  III    /  1— /  1  L>  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/DFOI/ 

JAY  S  TRIVEDI 
PATRIN  PHARMA  INC 

1    1  \  \  1  l  1  1  N    1     1   1 1  \  1  1 1  V  1 1  \    II  >IW 

MALLINCKRODT  -  METHYLPHENIDATE  ORAL  SOL  NDA  21  - 
41 9  1 0  MG,  5  ML  1 2/1 9/02;  TRISH  PHARMA  - 
METHYLPHENIDATE  ORAL  SOL  ANDA  91-601  5  MG,  5  ML 
7/23/1 0 

2012-7497 

10/17/2012 

1  \Jl    1    1  1  L—\J    1  L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \m/  Lri/  1  1  1/  v_-/  III    /  ( — /  1  ]  /  1  / 

LIA  OBATA  DOWD 

L_  1 1  \  Vw/  \—/ 1  \  1  1  \    lw/  Vw/  V  V  L/ 

MERCK  SHARP  &  DOHME  CORP  -  FOSAMAX  AERS  NDA 

i  v  1 1  i  i  Vw/ 1  \  \j  i  1 1  \  i  1 1     iwX  i — *  Vw/ 1  1 1  v  1 1— _  VuS  v»/  ill        i       \—j i  \ \  vin/\  i  v i_  i  i u ,  i  *j  j  / 1  \ . 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DOWD  &  DOWD  PC 

RESP 

2012-7498 

10/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

RITA  BECHARA 

AMARIN  PHARMA  INC  -  VASCEPA  NDA  202-057  PRVL  PKG 
7/26/12 

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V_/UI  III Ul  tt 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  ricLIUtJoLci 

OUUJtfOl 

Due  Date 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ACASTI  PHARMA  INC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7499 

10/17/2012 

1  \JI   1  /  /  S—\J  1  t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

CHESTER  C  STETFELT  JR 

PREMPRO  PROVERA-RECS 

1       1    1  1        1  V  1  1       1    I          m     1       11  \S  V  1— —  1    1 V    \           1    1 1        Vw/  ^w/ 

1  1  /  1  \Jf  C\J  \  C 

FDA/nMPT/nnFR/DRP/ninp/ 

\j  1  II  O  1  1  1  l  \_/  Oil      II    1  1     1    U  1  i  V_/ 1  V_/ 

FDA/DMPT/nnFR/nRP/nmp/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7500 

10/17/2012 

FDA/OGROP/ORA/CE-FO/MIN- 

\/\  /  f~\  N  1  iv  ■  i~  t  i  | —  1    a  1  1 1 —  DT\/ 

YVONNE  M  FLAHERTY 

PARADIGM  QUICK-bET  INFUSION  SETS  K01 1 071  -  EIRS, 

11/15/2012 

W/  1 VI 1 1  N   V_*  1  >  / 

LOCKRIDGE  GRINDAL  NAUEN 

P.MPI  NTS  FTP. 

01 VI r  LIN  1  O,  1      1  w 

FDA/OMPT/CDRH/OCER/DFOI/ 

PLLP 

OM/OMP/DODM/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

FDA/OGROP/ORA/SE-FO/SJN- 

UU/oJlN-Ub/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7501 

10/17/2012 

FDA/OF/CFSAN/OOD/EOS/ 

n  ATI  \  A  /  A  1    1  1 —  n 

PATI  WALLER 

DOCTORS  MEDICAL  CENTER,  MODESTO,  CA  - 

1 1/15/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

n  ji  a  n  i  i —  n  /"^  i    a  n  1/   a  ~i — r"\  /o 

MARLER  CLARK  ATTYS 

SALMONELLA  IN  INFANT  FORMULA  COMM,  LAB  RESULTS, 

DO/LOS-CB/ 

RPTS,  ETC  4/12,  5/12 

2012-7502 

10/17/2012 

ORA/ 

MONTY  DUCK 

BEF  FOODS  INC,  SULPHUR  SPRINGS,  TX  -  LAB  RESULTS 

11/15/2012 

ORA/ 

BEF  FOODS  INC 

9/1 1/12 

FDA/OGROP/ORA/SW-FO/DAL- 

DO/DAL-CB/ 

2012-7503 

10/17/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CARRIE  LUBINSKI 

MANGOES  OUTBREAK  OF  SALMONELLA  -  SPLS,  LAB 

01/11/2013 

ORA/ 

GORDON  &  REES  LLP 

NOTEBOOKS,  W/S,  ETC  2012 

ORA/ 

ORA/OE/ 

ORA/OE/ 

ORA/ORO/DFS/ 

ORA/ORO/DF^/ 

FDA/OC/OES/DFOI/ 

FD  A/OG  ROP/O  R  A/0  RO/D 1 0  PI 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SEA- 

Page  43  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 

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Signature/  Requester 

Subject 

Due  Date 

DO/SEA-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 

do/noi  -C.p,/ 

is \s  I 1 vj v_/ 1   \jLJf 

2012-7504 

10/17/2012 

ORA/ 

MARY  CLARE  JALONICK 

oi  i  k  1 1   a  Kin  in  ip     ^~\i  i  td  n  i —  a  iy  /~\  i —  o  a  i  k  ji/~\k.  i  i —  i  i   a  im  htami  it 

SUNLAND  INC  -  OUTBREAK  Or  SALMONELLA  IN  PEANUT 

11/15/2012 

ORA/ 

ASSOCIATED  PRESS 

BUTTER  483S  2009,  2010,  9/12 

2012-7505 

10/17/2012 

OC/COS/OES/ 

HHS  MANDATED  INVESTIGATION  OF  THE  OC  OR  00 

11/15/2012 

OC/COS/OES/ 

VANESSA,  STARKS 

OFFICE  OF  MANAGEMENT  RPT  INCLUDING  ANY  RELATED 

RECS  FOR  OFFICE  OF  MANAGEMENT  &  OFFICE  OF 

MANAGEMENT  PROGRAMS 

2012-7506 

10/17/2012 

1  \JI    1    /  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    J  / 1  \!  \w/ 1  v  1 1      1  /  \  '  l_/  1  1  1/  \w/  III    /  \S  1  i  /  1  / 

Dianp  Hawkins 

L/IQI  1 0    1   ICIVVIXII  1 0 

INDIVIDUAL  RECS 

1  1  M  IS  1  V  1  IS  Vw*  i  \  1—    1  1 1—  Vw*  Vw/ 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Hawkins,  Diane 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  Vw/  L-/  1  1  1/  Vw/  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7507 

10/17/2012 

1  \Jl    1    /  /  L—\J   1  I— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \w/  lw/  1  11   1/  Vw/  W  1—  1  1/  1  /  1    \s  11 

Allison  Knmivama 

/\  1 1 1  Jul  i  i  \  v/ 1 1 1 1  y  ci  i  1 1  ci 

K002612 

11/15/2012 

PaxMed  International 

2012-7508 

10/17/2012 

FDA/OC/OES/DFOI/ 

Allison  Komiyama 

K001143 

11/15/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

PaxMed  International 

2012-7509 

10/17/2012 

1  \Jl    1    /  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \S  1 V  1  1      11  \  '  IS  1  1  1/  Vw/  III    /  1— /  1  1— /  1  / 

LESLEY  S  ZORK 

1  l_  *S  1  1       1     w  Z  Vw/  1  1 1  \ 

INDIVIDUAL  RECS 

1  1  VI  IS  1  V  1  lw/  Vw*  /  \  L_    1  I  L_  Vw/  Vw/ 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JACK  H  OLENDER  LAW  OFCS 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1 V  1  1      1  /  W  IS  1  1  1/  Vw/  III    /  lw/  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7510 

10/18/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Allison  Komiyama 

K052168 

11/16/2012 

FDA/OC/OES/DFOI/ 

PaxMed  International 

2012-7511 

10/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Matthew  Stone 

NEW  ENGLAND  COMPOUNDING  CENTER  -  INVESTIGATION 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Cohen,  Placitella  &  Roth 

RECS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

FDA/OC/OES/ 

1  1— / 1  \l  Vw/  Vw//  Vw/  1 — VJ/ 

OC/COS/OL/ 

Vw/  Vw//  Vw/  Vw/  V — //  Vw/  1  / 

OC/OCC/ 

OC/OL/ 

2012-7512 

10/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Glen  Spielmans 

SYMBYAX  -  REVIEW  RECS 

Page  44  of  895 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Metropolitan  State  University  - 
Psyc  Dpt 

2012-7513 

L_  \J  1  £_     1  \J  t  V/ 

10/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    LJ 1  \l  Vw/  1 V  1  1      II  \J  LJ  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

Rophpi  .Inhn^on 

1  ldv.fl  Ivl   KJKJl  II  1 0 KJ  1  1 

NDA  21455  S7 

1  M  1  '  1    \    L—    1      1^ \J \J     ^J  i 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

^01  ^-751 4 

10/18/<;01<; 

rUA/UG/Utb/DrUI/ 

b  1  JUDh  MtUIOAL,  bUMAH,  OA  -  483  09/01/^01 2.  -  1 1/a0/^(j1 2. 

11/16/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

RBC  CAPITAL  MARKETS 

2012-7^1 5 

10/18/2012 

1  KJI   1  KJI  C-KJ  1 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  / V/  Vw/ 1 V  1 1      1  /  \w/  l_/  1  1  1/  W  III    /  [_/  1  1— /  1  / 

Rarhpl  .InhnQnn 

1  IQ<jI  lul  UUI  II  IOUI  1 

NDAS04C5£S  -  TOXICOLOGY  DATA 

1  1L/n\JwT^i/iJ          1  v/AIUv/LWVJ  1     l_/ 1  \  1  1  \ 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  I  \l  Vw/ 1 V  1  1      1  /  \_S  1— •*  1  1  1/  V_/  III    /  1— /  1  L>  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7516 

L—  \J   1  L     /  *J  1  V/ 

10/18/2012 

1  KJI   1  KJI  C-KJ  1 

11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— '  / V/  Vw/ 1 V  1 1      1  /  \_/  L/  1  11   1  /  V_/  W  1  1  \!  LJ  1    Vw/  1  / 

HemoSonics  LLC 

K083842 

2012-7517 

L—  \J    1  £_     1   \J   \  1 

10/18/2012 

1  Kjl    1  (_>/  L-\J  1  I— 

11/16/2012 

FDA/OF/CFSAN/OOD/EOS/ 

1  1— '  / V/  Vw/  1    /  \J  1    V  '  I  V 1  \J  /  Vw/  Vw/  l_y  /  1  Vw/  Vw/7 

Aarnn  Knrhman 

I  \  d  i  KJI  l  IvUV^IIIIIClll 

Lauren  AgriSystems 

ALLOWABLE  CARBON  BLACK  LOADING  21  CFR  177  2600 

1  \  1  1  Vw/  V  V  1  \  1  J  1  1        \J  I  \  1  lUv/l  \    \—3  1  r\WI  \    1  Vw//  \  LJ  1 1  >J  V»/      L—  1     \J\    11     III  .CKJKJKJ 

2012-7518 

10/18/2012 
11/16/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Christopher  Weaver 

THE  WALL  STREET  JOURNAL 

ST  JUDE  MEDICAL,  SYLMAR,  CA  -  CORR  RE  ONGOING 
INSPECTION 

2012-7519 

L_  \_/    1  L—      /    \J    \  -J 

10/18/2012 

1  KJI   1  KJI  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  '  1    \l   Vw/  1  V  1  1          1    /  Vw /  1— '  1         |     1/   W  III       /  1— /  |  1  /  |  / 

Rarhpl  Johnson 

1  ldv/1  1  v^  1  UUI  II  IOUI  1 

NDA202236 

1  *J  LJ 1  V  C—  \J  L—  L—  \J  KJ 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    LJ 1  \l  Vw/  1  v  1  1      1  /  \J  LJ  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7520 

10/18/2012 

1  KJI   1  KJI  L—KJ  1  £_ 

11/16/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

WINGARD,  MICHELLE 

FOIA  REQUESTS  8/1/12  TO  9/1/12 

1    Vw/  1 1  \    1  1 1  KJ  1— —  \J  1  Vw/  V//    1  /    1  £_     1  Vw /   v/  /    11    1  £— 

2012-7521 

10/18/2012 

1  V//   1  KJI  L—\J\C— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      II  \J  LJ  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

ALLISON  CHEN 

I  \  1  1  1  \J  Vw/  1  x    \J  1   1  1— —  1  M 

HERAEUS  KULZER  LLC  -  GLUMA  DESENSTITZER  POWER 

1   1  1  1  VI  \  1  KJ  KJ    1  \  Vw/  1    '    l_  1  I    1_  1_  Vw/              1  KJ  1 V 1 1  \    LJ  1—  Vw/  1  1  \  Vw/  III  L  1  1  1    1     Vw/  V  V  1— —  1  1 

11/16/2012 

HARVEST  CONSULTING  CORP 

GEL  K093575 

2012-7522 

10/18/2012 

1  KJI   1  KJI  t—\J\l— 

1 1/16/2012 

1     1  /     1   KJI  L —  \J    1  L — 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  Vw /  1— '  1  11   1/  V_/  v^/  l_  1  1/  1 — /  1    Vw/  1/ 

FDA/OC/OES/DFOI/ 

i  i— '  /  \i  Vw/  v//  Vw/ 1— _  V-//  i— /  i   VwX  i/ 

ALLISON  CHEN 

I    \  1        1        1  \J  Vw/  I    *J      \J  i      1 1_  i  V| 

HARVEST  CONSULTING  CORP 

COLGATE-PALMOLIVE  CO  -  COLGATE  DESENSTIZING 

\j Vw/ Lv^n  i  i      i   i  \ L—  i  v  i  Vw/ 1  i  v  i_  \j Vw/      Vw/ v_/ Lv/n  i  i      i_/ 1  1  i  v \j  i  i ^  1 1  vi  v^i 

DENTAL  CREAM  K1 03461 

2012-7523 

10/18/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALLISON  CHEN 

HOENIX  DENTAL  INC  -  SUPER  SEAL  TOOTH  DESENSITZER 

11/16/2012 

HARVEST  CONSULTING  CORP 

K120109 

2012-7524 

10/18/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALLISON  CHEN 

JENERIC/PENTRON  INC  -  QUELL  DESENSTIZER  K010957 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/16/2012 

FDA/OC/OES/DFOI/ 

HARVEST  CONSULTING  CORP 

2012-7525 

10/18/2012 
11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  \w/  1 V  1  1      1  /  \  '  is  1  11   1/  \S  \  '  l_  1  1/  1 — /  1    Vw/  J/ 

PIA  MALBRAN 

1     1 1  \    1  V  1 1  \  1  IS  1  I 1  \  1  VI 

CBS  MIAMI 

DETLOGIX  ANNULOPLASTY  RING  -  K083191 

IS  1       1  l_  \w/  > — A  1  /  \   /  VI  11  v  *S  1—  Vw/  1     1  /  \\S  1     1     1  111  v  > — A        \  WJ\J\J  1  \J  1 

2012-7526 

10/18/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

SANDRA  BROWN 

REICHERT  INC  -  POD  PAC  20M  CORNEAL  PACHYMETER 

11/16/2012 

REICHERT  TECHNOLOGIES 

SYS  K03061 0 

2012-7527 

10/18/2012 
11/16/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

ls\JI  l—y  1  ,  1     \  /  1  '/ 

BAXTER  PHARMACEUTICAL 
SOLUTIONS 

BAXTER  PHARMACEUTICAL  SOLUTIONS,  LLC, 
BLOOM1NGTON  IN  -  EIR  01/03/2011  -  10/17/2012 

IS  1  Vw/  Vw/ 1 V 1 1 1  N  \si  1  \s  1  N  .    IIM        1  1  1  1  \J  1  1  UU/  LU  1    1          1  \J/  1  1  I  C—\J  \  C— 

2012-7528 

10/18/2012 
11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Annette  Nelson 
CooperVision,  Inc. 

K1 00456 

2012-7529 

10/18/2012 
11/16/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

MATHEWAZEPNICK 

EDELSTEINS  FAEGENBURG  & 
BROWN  LLP 

TRANS1  AXIAL  LIF  2L  ANTERIOR  SPINAL  FIXATION  - 
INVESTIGATIVE  RECS  7/8/10 

I  I  *l  V  1—  *S  1  1  K^l  \  1  1  V  1—    1  1 1_  \w /  Vw/    /  /  \J1    1  w 

2012-7530 

10/18/2012 
11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  \S  1 V  1  1      1  /  \S  IS  1  11   1/  W  \w /  l_  1  1/  \S  1    \S  11 

Annpttp  Npl^on 
CooperVision,  Inc. 

K1 00349 

2012-7531 

10/18/2012 
11/16/2012 

FDA/OMPT/CTP/OD/ 

THE  ASSOCIATED  PRESS 

CTP  -  NUMBER  OF  EMPLOYEES  WORKING  ON  REVIEW  OF 
SUBSTANTIAL  EQUIVALENCE  APPLICATIONS 

2012-7532 

10/18/2012 
11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHN  E  HALL 
MEDICINE  HALL 

PHILIPS  HEARTSTREAM  -  PHILIPS  HEARTSTART  HOME 
DEFIBRILLATOR  K040904,  K020715,  K003565  CLEARANCE 
LTR  &  PROD  INSERT 

2012-7533 

10/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      11  \S  IS  1  1   If  W  III    /  I — '  1  1— '  1  / 

CIPRO  (CIPROFLOXACIN)  -  AERS 

Vw/  II    11  \S  \     '  II    11  VwS  1    Lw/xnu  1  1  X  (       V  \  1  1  1  \s 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MATHERNE,  MICHAEL  MARK 

2012-7534 

10/18/2012 
11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  1  1  1/  W  III    /  \S  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ASHLEY  E  BASS 

I  \  \S  1   1  L_  l_  1      E        IS  I  \  S 

COVINGTON  &  BURLING  LLP 

BUDEPRION  XL  300  MG  fWELLBUTRIN  XL  300  MG)  - 

IS  \S  IS  1  1     III  \s  IN    /  \  L_  \J  \J\J    1  v  1          \  V  V  1— —  L_  1_  IS  \S  1  1   1 1  1  V    /  \  1—            \J    1 V 1  \^  1 

MEETINGS,  COMM,  SUBMISSIONS,  ETC 

2012-7535 

10/18/2012 
11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

THOMAS  P  VALET 
RHEINGOLD,  VALET,  ET  AL 

FDA  SCIENCE  BACKGROUND  PAPER:  ACUTE  PHOSPHATE 
NEPHROPATHY  &  RENAL  FAILURE  ASSOCIATED  WITH  THE 
USE  OF  ORAL  SODIUM  PHOSPHATE  BOWEL  CLEANSING 
PRODS;  FDA  SAFETY  INFORMATION/WARNING 
REGARDING  FLEET  PHOSPHO-SODA  &  FLEET  ACCU-PREP 
5/5/06  (CERTIFIED) 

2012-7536 

10/18/2012 
11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SANJAY  H  SHARMA 
HETERO  USA  INC 

GLUCOTROL  XL  (GLIPIZIDE  ER  TABS)  2.5  MG,  1 0  MG  - 
CHEMISTRY  RVWS,  SBA,  BIOEQV 

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Total  Records:  9990 


V_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl u/  ricLjUtJoLci 

OUUJtfOl 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

FDA/OC/OES/DFOI/ 

2012-7537 

10/18/2012 
11/16/2012 

FDA/OF/CFSAN/OCD/EOS/ 

JONES  06-A-0604,  VERNON 

WHAT  ANIMAL  IS  THE  SURCE  OF  SOYA  LECITHIM 
ARTIFICAL  COLORS  ACID,  ETC 

2012-7538 

10/18/2012 
11/16/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LISA  Y  LEFFERTS 

CENTER  FOR  SCIENCE  IN 
PUBLIC  INTEREST 

SEARLE  LABS  -  TWO  YR  TOXICITY  STUDY  IN  THE  RAT,  104 
WEEK  2  GENERATION  IN  UTERO  STUDY  IN  RAT,  1 15  WEEK 
ORAL  TUMORIGENCITY  STUDY  IN  THE  RAT 
CARCINOGENICITY  STUDIES  ON  ASPARTAME 

2012-7539 

10/18/2012 
11/16/2012 

ORA/ 
ORA/ 

MARTINA  BERNSTEIN 

lvl/\l  1  1  1 1  in  1  )  1  1  1 1  n  w  1  1  111 

PETA  FOUNDATION 

BOVINE  SPONGIFORM  ENCEPHALOPATHY  -  MEMOS 

1  I  Vw/  Villi       \s  1    Vw/  1  i  v  \  1  1    Vw/  1  11 VI    1  11  \J  1  1    1  1 1  \  i  Vw/  1    1  \  1  1  1  1         1 VI 1  1  V  1  \s  \s  , 

RPTS,  EVALUATIONS,  ETC 

2012-7540 

10/18/2012 
11/16/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

MELANIE  COURTOT 

UNIV  OF  BRITISH  COLUMBIA 

ADVERSE  EVENTS  FOLLOWING  INFLUENZA  A  (H1N1) 
MONOVALENT  VACCINES  10/09  TO  1/31/10 

2012-7541 

10/18/2012 

ORA/ 

DOLE  CORP  -  SPINACH  RECS 

11/16/2012 

ORA/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Doe  J 

2012-7542 

10/18/2012 

1  \Jl    1  \JI  L—\J\S— 

11/16/2012 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

JEFF  STACHEWICZ 

%J  1—  1    1      \J  1  /  \  — /  1   1  l_  V  V  1  \S  £.  

FOIA  GROUP  INC 

MC252  WELL  -  IDENTIFYING  COMPOSITON  OF  OIL 

1 V  1  Vw/ £_ \_y L_    V  V  1— —  1  i—        1  IS  1  1  1  1  1 1      1   1 1  1  \J    v/  Vw/ 1  V 1 1     Vw/ *S  i  1  Vw/  1  1    Vw/  1      Vw/  1  L. 

QUANITY  OF  OIL,  FATE  &  TRANSPORT,  ETC 

2012-7543 

10/19/2012 
11/19/2012 

OC/OM/OMP/DDIW 

Vw /  Vw/;  Vw/  1 V  1/  Vw/  1  v  1  1    /  1 — /  IS  1  V 1/ 

MARILYNN  WHITNEY 

i vin i  ul  i  i  ii  v  vv  i  ii  i  ii i_  i 

COVINGTON  &  BURLING  LLP 

DKT  FDA-2012-P-0904 

IS  1  V  I     1    IS  1  \    L_ \J  1  L—    1       \J \J\J^T 

2012-7544 

10/19/2012 
11/19/2012 

OC/OM/OMP/DDM/ 

GABRIEL  SHERMAN 

Hyman  Phelps  and  McNamara  PC 

DKT  FDA-2012-P-0939 

2012-7545 

10/19/2012 

ORA/ 

AnnMarie  Beattie 

ENTRY  G76-01 29053-7  -  LAB  RESULTS 

11/19/2012 

ORA/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Harmonized  Customs  Brokers,  Inc 

2012-7546 

10/19/2012 

1  \Jl    1  \J/  L—\J\S— 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  VwS  L/  1  11   1/  V»/  V  '  l_  1  1/  \S  1    Vw/  1/ 

Ofpk  1  pvin 

Vw/  1  v_/ 1 V    1  \J  VIII 

Via  Surgical  Ltd 

K091900 

1  WJ  \J  1  \J\J\J 

2012-7547 

10/19/2012 

1  \JI   1  sJI  t—\J  1  C— 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  l — '  /  V/  Vw/  1  v  1  1      1  /  Vw*  Lp/  1  11   1/  V_/  Vw*  1— —  1  1/  IS  1    Vw/  1/ 

Ofpk  1  pvin 

Vw/  1  v_/ 1 V    1  \J  V  1 1  1 

Via  Surgical  Ltd 

K093845 

2012-7548 

10/19/2012 
11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Huan  Tran 

1   1  \A  \-X  1  1     1  1  Ct  1  1 

Next  Orthosurgical,  Inc. 

K1 1 01 25 

2012-7549 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Molly  Moore 

Leader,  Bulso  &  Nolan 

NEW  ENGLAND  COMPOUNDING  PHARMACY  - 
INVESTIGATIVE  RECS,  CORR,  MEMOS,  ETC. 

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Pnntrnl  if 

nfciOU  L/dLc  / 

Due  Date 

MOLIUll  wlllLrC 

oiyiidLure/  r\e(_]uebLcr 

Ci  1  |[~li£!l/"»t 

ouujeci 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

2012-7550 

10/19/2012 

1  \JI    1  \JI  L-\J  1  C 

11/19/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

1  1 — /  /  V/  \w/  > — A  1   1  V_/  1    /  \w/  1  1/  V/  Vw/  l_    1    Vw/ /  1  III 

DO/PHI-CB/ 

R^rhpl  .lohnQnn 

1  IdUl  1  \j  1  uUI  II  IOUI  1 

FOI  Services,  Inc. 

MERCK   WEST  POINT  PA- EIRq  48^  OORR  C01/01/200Q- 

Ivll  1  1  V/  1  \    ,    VVI  \J  1     1     V_/  1 1  >l  1  ,    1    I  \      1  II  IO,   TUUO,    V/ Vw/  1  11  1    1  u  l/U 

12/31/2010) 

2012-7551 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

1    ]  /  /  V/  \w/  \J  1  1  Vw/  1    /  Vw/  1  If  V/  V/  l__    1             1  III 

DO/PHI-CB/ 

Hoi li  Baker 

1   1  \J  1  1 1    L/  CX 1  Vtj  1 

Ridley,  McGreevy  &  Winocur  P.C. 

REACTION  NUTRITION  CARNEGIE  PA  -  483  RESPONSE 

1  1 1  /  V  Vw/  1  1  Vw/  IN    1  M  V/  1  1  1 1  1  1  Vw/  1  >l  ,    Vw/  /  V 1  1 1  >l  l_  V_/  1  1  ,    1     /  \          i  V/  \-)  1    1   1  l_  V/  1     Vw/  1  M  Vw/  1  

4/22/2010  -  10/17/2012 

2012-7552 

10/19/2012 
11/19/2012 

FDA/OMPT/CTP/OD/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  1  1    /  Vw/  (  /  / 

Rarhpl  Johnson 

1  IGIUI  1 V/ 1   UUI  II  IOV/1  1 

FOI  Services,  Inc. 

TOBACCO  PRODUCT  LISTING  FOR  ALTRIA  PHILIP  MORRIS 

1  Vw/  I  f  1  \  Vw/  Vw/  Vw/    1     1  I  Vw/  I  /  V/  V/  1     1  1  V_/  1  1  1  N  V_/    1    Vw/  |  I  /  \  L  1  1  1 1  /  \ .    1     III  1  II       1  V 1  Vw/  1  1 1  I  1  u . 

SMOKELESS  TOBACCO 

2012-7553 

10/19/2012 
11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  \J  L/  1  11   1/  Vw/  V/  l_  1  1/  1  /  1    Vw/  1/ 

Allison  Komivama 

I  \ 1 1  ioui  i  i  v kj  1 1 1 1  y  ci  i  1 1  ci 

PaxMed  International 

K1 12860 

1  V  I    1  LUvv 

2012-7554 

10/19/2012 

1  \JI     1   \JI  t—\J    1  L— 

11/19/2012 

FDA/OMPT/CTP/OD/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  1  1    /  Vw/  L/  / 

Rarhpl  Johnson 

1  lUvl  1 V/ 1   UUI  II  IOV/1  1 

FOI  Services,  Inc. 

CORR  BETWEEN  CTP  AND  INDUSTRY  RE  CAPSULES  IN 

WW  1  1 1  I  I— J  1       1    V  V  1  1  1  \J    Vw*  1  1      1  VI  v  l_/    1  1  v  L/  V/        1  1  1  1      11 1        V_/ 1  \  \     \w/  V/  1  l_  U  111 

CIGARETTES 

2012-7555 

10/19/2012 

1  \Jl    1  \JI  L—\J\S— 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  l_  1  1/  l_/  1    Vw/  1/ 

Allison  Komivama 

I  \ 1 1  ioui  i  i  v kj  1 1 1 1  y  ci  i  1 1  ci 

PaxMed  International 

K1 03254 

1  V  I  uu^u^ 

2012-7556 

10/19/2012 

1  \JI     1   \JI  t—\J    1  L— 

11/19/2012 

FDA/OMPT/CTP/OD/ 

1          1  '  /      V/    Vw/  1  V  1   1             1     /    \w/      1       1         /    Vw/  |_/  / 

Rarhpl  Johnson 

1  IGIUI  1 V/ 1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

LIST  OF  PRODUCTS  -  ALTRIA  CLIENT  SERVICES  PHILIP 

1  1  V»J  1     Vw/  |       |     |  l  Vw/  1 — 1  V/  Vw/  1  U        /  \  1       1  1  1  1  /  V  Vw/  1—  1  1  1  M  1     \J  \—  1  I  V  1  V/  1  Vw/  ,    1     1   1  1      1  1 

MORRIS  USA  INC,  SMOKELESS  TOBACCO  LLC  ETC 

2012-7557 

10/19/2012 

1  \Jl    1  \J/  L—\J\S— 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  / 1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  Vw/  l_  1  1/  1  /  1    Vw/  1/ 

Allison  Knmivama 

I  \ 1 1  ioui  i  i  v v/ 1  i  1 1  y  ci  i  1 1  ci 

PaxMed  International 

K083770 

2012-7558 

10/19/2012 
11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ofek  Levin 
Via  Surgical  Ltd 

K092483 

2012-7559 

10/19/2012 

1  \JI    1  \JI  L—\J\S— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  Vw/  L/  1  1  1/  Vw/  III    /  1 — '  1  l_/  1  / 

Alpyandra  Pprrpitpr 

I  \  IUAQI  1  \A  1  CL    1     Ul  1        Iv  1 

RIVAROXABAN  -  AERS 

i  ii  v  I  \ i  i Vw/ / vy  \ i—ji  \ i  x      i  v i_ i  i ^^/ 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Sharp  Memorial  Hospital 

2012-7560 

10/19/2012 
11/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Michael  Keegan 
WaterCensus 

BOTTLED  WATER  COMPANIES  -  TESTING  DATA  RESULTS 
SUBMITTED  TO  FDA  UNDER  CURRENT  REGULATIONS 
(01/01/2011  -  12/31/2011) 

2012-7561 

10/19/2012 
11/19/2012 

FDA/00/ 

John  Crewdson 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

LIST  OF  MEDICAL  OFFICERS  AT  FDA 

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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7562 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

UNITED  1  INTERNATIONAL  LABORATORIES  LLC, 
CARROLLTON,  TX;  HOSPIRA  INC,  AUSTIN,  TX;  MEDICA 
RENTS  CO  LTD,  FORT  WORTH,  TX  -  483  8/12 

2012-7563 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

JOHNATHAN  RICKMAN 

U  Vw/  1   1  1  N  /  \  1  1   1 1  \  1  il    111  V/  1  \  1  V  \t\  1  N 

FDA  NEWS 

BARTON  CAREY  MEDICAL  PRODUCTS  INC  MAUMEE  OH' 

1  It  \  \  \  \  Vw/ 1  *J    V/ 1  \  \  11       1     Ivll  L/IUnl       1     1  1WL/U\J  1  VJ    1 1  M  \J  ■    1  V  1  f\  VJ  1  V  1 1  1  ,    Vw/  1  1, 

KDB  INC,  CRESENT  SPRINGS,  KY  -  483  8/12 

2012-7564 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

JOHNATHAN  RICKMAN 

\J  V^/  1   1  1  N  /  \  1  1   1 1  \  1  il    III  V/  1  \  1  V  l/\l  N 

FDA  NEWS 

BLISTEX  INC  OAK  BROOK  IL'  PHOENIX  INSTRUMENTS  INC 

1  )  1  1  V  '  1  1  /\    1 1  >l  v_/  ,    Vw/ 1  \  \  V    Ul  IV_/V_/I\1    II  .    1     1   1  Vw/  1  1  M  IA    II  NVj  1  1  lUIVII  IN  1  \J    1  1  N  V  /  . 

NAPERVILLE,  IL  -  483  8/12 

2012-7565 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

ALLO  SOURCE  INC,  CENTENNIAL,  CO;  MOOG  MEDICAL 
DEVICES  GROUP,  SALT  LAKE  CITY,  UT  -  8/12 

2012-7566 

10/19/2012 

a  a   '  a  r\  i  r~\  /~\  4  r\ 

1 1/19/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARACO  PHARMACEUTICAL  LABORATORIES  LTD, 
DETROIT,  Ml;  PHARMACIA  &  UPJOHN  LLC,  KALAMAZOO,  Ml 
-483  8/12 

2012-7567 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

MDR  FITNESS  CORP,  SUNRISE,  FL;  HILL  DERMATEUTICALS 
INC,  SANFORD,  FL;  NEPHRON  PHARMACEUTICALS  CORP, 
ORLANDO,  FL  -  483  8/12 

2012-7568 

10/19/2012 
11/1 9/2012 

1     1  /     1   \JI  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  l_/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

1    1  /  /  V   1  x  1      V  V  V/ 

TAKEDA  PHARMACEUTICAL  CO  LTD,  OSAKA,  JAPAN; 
UNITED  BIOMEDICAL  INC,  HSIN  CHU  HSIEN,  TAIWAN; 
CONCORD  BIOTECH  LTD,  AHMEDABAD,  GUHURAT  STATE, 
INDIA  -  483  8/12 

2012-7569 

10/19/2012 
1 1/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 

i — I- \  A    h  1  i — \  A  /  o 

FDA  NEWS 

SUZHOU  HUANQIU  ACUPUNCTURE  MEDICAL  APPLIANCE 
CO  LTD,  SUZHIU  CITY,  CHINA;  TONICA  ELEKTRONIK  AS 
FARUM,  DENMARK;  RICHWAY  NF,  SEOUL,  KR  -  483  8/12 

2012-7570 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

KC  PHARMACEUTICALS  INC,  POMONA,  CA;  VITAMINERALS 
INC,  GLENDALE,  CA;  BEAUTY  HEALTH  &  SCIENCE 
INNOVATIONS  INC,  PICO  RIVERA,  CA  -  483  8/12 

2012-7571 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

INCONTROL  MEDICAL  LLC,  BROOKFIELD,  Wl  -  483  8/12 

2012-7572 

10/19/2012 

a  a  l  a  r\  ir\/~\  4  r\ 

1 1/19/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

JHONATHAN  RICKMAN 
FDA  NEWS 

VERTEX  PHARMACEUTICALS  INC,  CAMBRIDGE,  MA; 
ALEXION  PHARMACEUTICALS  INC,  SMITHFIELD,  Rl; 
TENDER  CORP,  LITTLETON,  NH  -  483  8/12 

2012-7573 

10/19/2012 

a  a  l  a  r\  1  f~\  /**  a  r\ 

1 1/19/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

ELITE  LABORATORIES  INC;  SUITE  K  VALUE  ADDED 
SERVICES  LLC,  EDISON,  NJ;  WEST-WARD 
PHARMACEUTICAL  CORP,  EATONTOWN,  NJ  -  483  8/12 

2012-7574 

10/19/2012 
11/19/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

ZION  ORGANICS  INC,  SAINT  ALBANS,  NY;  SAFETEC  OF 
AMERICA  INC,  BUFFALO,  NY;  COLUMBIA  PRESBYTERIAN 
MEDICAL  CTR,  NEW  YORK,  NY  -  483  8/12 

2012-7575 

10/19/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

JOHNATHAN  RICKMAN 

GUARDIAN  ANGEL  PRODUCTS  INC,  HUNTINGDON  VALLEY, 

Page  49  of  895 


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Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


11/19/2012 

DO/PHI-CB/ 

FDA  NEWS 

PA;  SPRING  HEALTH  PRODUCTS  INC,  NORRISTOWN,  PA; 
GLYCADIA  INC,  PHILADELPHIA,  PA  -  483  8/12 

901  9-7^7fi 

1  fl/1  Q/901  9 

FnA/nPROP/PlRA/PA-FPj/^AM- 

IPlHMATHAM  RIPKMAM 

TFYPHFM  PHFMIPAI  PPj  ClAPRAMFMTO  PA-  PFMFMTFPH 

11/1  Q/901  9 

DO/SAN-CB/ 

FnA  MFW"^ 

INC,  SOUTH  SAN  FRANCISCO,  CA;  CONSESNSUS 

ORTHOPEDICS  INC,  EL  DORADO  HILLS,  CA  -  483  8/12 

901  9-7^77 

1  fl/1  Q/901  9 

FnA/nnROP/nRA/rF-FO/Ri  t- 

IDHMATHAM  RIPKMAM 

PAMPFMF  RIPiPHARMA  IMP  RAI  TIMPjRF  Ml")-  HAWKMAD 

11/1  Q/901  9 

DO/BLT-CB/ 

FDA  NFWS 

MANUFACTURING  INDUSTRIES  INC,  ALEXANDRIA,  VA;  IBA 

MOLECULAR  NORTH  AMERICA  INC,  MORGANTOWN,  WV  - 
483  8/12 

2012-7578 

10/19/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

JOHNATHAN  RICKMAN 

GILES  CHEMICAL,  WAYNESVILLE,  NC;  CAROLON  CO, 

11/19/2012 

DO/ATL-CB/ 

FDA  NEWS 

RURAL  HALL,  NC,  PERKIN  ELMER  HEALTH  SCIENCES,  SC  - 
483  8/12 

2012-7579 

10/19/2012 

FDA/OGROP/ORA/PA-FO/SEA- 

JOHNATHAN  RICKMAN 

PETNET  SOLUTIONS  INC,  SPOKANE,  WA;  PARKS  MEDICAL 

11/19/2012 

DO/SEA-CB/ 

FDA  NEWS 

ELECTRONICS  INC,  ALOHA,  OR;  ELECTRODE  STORE  INC, 
BUCKLEY,  WA-483  8/12 

2012-7580 

10/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JOHN  P.  HARLOE,  JD,  PhD 

OBSTETRICS  AND  GYNECOLOGY  MEDICAL  DVCS  A/C  - 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OM/OMP/DODM/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FREESE  &  GOSS,  PLLC 

PELVIC  MESH  RECS  ,  CORR  9/8/1 1 

2012-7581 

10/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHN  P.  HARLOE,  JD,  PhD 

PELVIC  MESH  STUDY  PROTOCOLS,  ENFORCEMENT 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

FREESE  &  GOSS,  PLLC 

ACTIONS,  CORR,  ETC 

2012-7582 

10/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Bill  Lesko 

TETATOLOGICAL  EVALUATION  STUDIES  OF  FDA  71-28 

11/19/2012 

Arizona  Chemical,  LLC 

(NATURALLY  OCCURING  SUBSTANCE  FROM  PINE  TREES) 

2012-7583 

10/21/2012 
11/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Anna  Edney 
BLOOMBERG  NEWS 

CAERS  REPORTS  -  01/01/2004  -  10/19/2012 

2012-7584 

10/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Nicki  Steel 

KELLOGG'S  MORNING  STAR  FARMS  -  CORR  RE  LABELING 

11/19/2012 

FDA/OC/OES/DFOI/ 

Nicki  Steel 

INFORMATION  FOR  SERVING  SIZE  OF  MEAL  STARTER 
CRUMBLES 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

2012-7585 

10/21/2012 

CVM/OCD/ 

JoNel  Aleccia 

YANTAI  ASKA  FOODS  CO  LTD,  SHANDONG,  CHINA  -  EIR 

11/19/2012 

MSNBC.COM 

03/28/201 2  -  03/30/201 2 

2012-7586 

10/21/2012 
11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

CORIN  USA 

K922841 

2012-7587 

10/21/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16) 

2012-6780  REQUEST  LETTER 

Page  50  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
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Action  Office 

Signature/  Requester 

Subject 

11/19/2012 

MERCK  &  CO.,  INC. 

2012-7588 

10/21/2012 

1  \JI  L—  1  /  t—\J  1  L 

11/19/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-6487 

2012-7589 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   IVJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-6663 

2012-7590 

10/21/2012 

1  \Jl  C—  1  /  t—\J  1  L 

11/19/2012 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-6271 

2012-7591 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   1  VJVJLV/L/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-6270 

2012-7592 

4__  W    1   L_      /    v/  v/  L_ 

10/21/2012 

1  \Jl  <—  1  /  t—\J  1  L 

11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-61 18 

2012-7593 

fc-W  1  £_    /  v/  V/ 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    WLILl   IVJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-5604 

L—\J   \  L—    v/  V/  V/  1 

2012-7594 

10/21/2012 

1  \JI  L—  1  /  t—\J  1  L 

11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-321 1 

2012-7595 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

UUCll  1    WLILl   1  VJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2010-3929 

2012-7596 

10/21/2012 

1  \Jl  C—  1  /  t—\J  1  L 

11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-6641  REQUEST  LETTER 

2012-7597 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    WLILl   1VJVJLV/L/     1  \J  I 

MERCK  &  CO.,  INC. 

2012-6956  REQUEST  LETTER 

L_  V_/  |  £_    V/  v/  v/  V/      1  1L-VXV/L-^  1     1_  l_  1     1   L_  1  I 

2012-7598 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-6625  REQUEST  LETTER 

L—  \J  1  L       V/  V/  L_  v/      1  IL-VX\JL-VJ  1     1—  1— —  1     1  L_  1  I 

2012-7599 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-6685  REQUEST  LETTER 

L—  \j  \  C—  UUUJ     1  11  W  V_/  1  v  )  i    1  1      i    i  i  i  i 

2012-7600 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   1  VJVJLWLf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-6604  REQUEST  LETTER 

t—\J  1  C—   UUUT     1  11  \j<  W  1  v  '  1     1  1       1    1  1  1  1 

2012-7601 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-6824  REOUEST  LETTER 

L—  W  1  C—   UULT  1  1 1  Vj<  VJ  1  w  1     1  1       1    II  11 

2012-7602 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

i  i— '  /  \/  Vw/  v//  Vw/ 1— _  V-//  i— /  i   VwX  i/ 

Joan  Stitt  (UG2CD-16} 

\J  wLil  1    w  LI  L  L    V  V/  Vwi  L —  Vw/  1 — /  IV// 

MERCK  &  CO.,  INC. 

2012-6876  REQUEST  LETTER 

2012-7603 

10/21/2012 
11/19/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16) 
MERCK  &  CO.,  INC. 

2012-6891  REQUEST  LETTER 

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Control  # 

Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

2012-7604 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K926344 

2012-7605 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K881604,  K760152,  K771046,  ETC 

2012-7606 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K880660,  K863492,  K905289,  ETC 

2012-7607 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K991764,  K930428,  K952684,  ETC 

2012-7608 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K893626 

2012-7609 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K922164,  K914350,  K913641,  ETC 

2012-7610 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K942146,  K885054,  K953255,  ETC 

2012-7611 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRENT  M  ARDAUGH 

NORTHWESTERN  UNIV 
FEINBERG  SCHOOL  OF 
MEDICINE 

K003358,  K961160,  K010726 

2012-7612 

10/22/2012 

1  V//  C—C—l  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

MARIE  RUFRANO-WILSON 

1  V 1 1  \  1  1 1  l__    1  I  V  '  1     1  1 1  \  L  N  \w/     V  V  1  LUV  1  *l 

CARDINAL  HEALTH  INC  -  LEADXER  LABELER  CODE  37205 

\-s  1  \  1  1 1  '  1 1  *J  I  \  l_    1   1 1  /  \  1      III    1 1  N  Vw/        1  1  /  \  1  /  /  \  1  1  1    1  I  \  \  )  l_  [_  l_  1  I    Vw/  Vw/  ]  /  l_   \J  1  L—  \J  \_y 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CARDINAL  HEALTH 

2012-7613 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

MARIE  RUFANO-WILSON 

CARDINALHEALTH  INC  -  THE  MEDICINE  SHOPPE  LABELER 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CARDINAL  HEALTH 

CODE  49614 

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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7614 

10/22/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

DOUGHLAS  N  BLUE  II 

SYNTHES  SMP  SA  DECV  CTO  MEDICAL  N  49,  SATELITE 

11/20/2012 

DO/FLA-CB/ 

ZETETIC  INC 

NAUCALPAN,  MEXICO  -  SYNTHES  MEDICAL  INSTRUMENTS 
FNTRY  TQdnn^^ftcn 

2012-7615 

10/22/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

1  1 — '  /  V/  Vw/        1   1 W  1    /  Vw/  1  1/  V/  1  VI  1— —    1    V-/  I  1  N   1  1  \ 

DOUGLAS  N  BLUE  II 

1— /  V^/  Vw/  \s\  l—l  \V_J    1  VI    L/  1—  Vw/  l_    1  1 

TOILETRIES  fCOCOA  LOTION  ALOE  LOTION  ESSENTIAL 

1  Vw/  1  [_  l_   1    1    1 1  1       U    \  V/  Vw/  V/  Vw/  /   V    L_  Vw/   1    I  Vw/  1  i|  .    /   iLv  1         l_  V  /   1    I  Vw/  1  i|  ,     L_  Vw/  V/  1       1        1    1 1  \  1  

1  1  /  C\JI  <—\J  \  c 

DO/NYK-DCB/ 

7FTFTIH  INf; 

MOISTURIZER)  ENTRY  10908618795 

2012-7616 

10/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BRIAN  BELL 

A  TABLE  OF  ALL  MDRS  IN  MAUDE  -  MDR  RPT  KEY  &  THE 

1 1/20/2012 

BOSTON  SCIENTIFIC 

1  }  V*/        1  Vw/  1  V|    \S  Vw/  1  1  1  il  1  1  1     1  Vw / 

PATIENT  PROBLEM  CODE 

2012-7617 

10/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— /  1  \l  Vw/  1  v  1  1      1  /  V- /  L/  1  11   1/  V_/  \_s  1—  1  1/  1 — /  1    Vw/  1/ 

CHANGES  TO  OR  MODIFICATIONS  OF  FORM  FDA  3429 

V-/  1   It  VI  i|        l_  Vw/     1  Vw/  Vw /  II    1  v  1  V — /  1 — '  1  1     1  Vh//%  1  1  V^/  1  V \J    V_/  1       1    Vw/  1  1 1  v  1    1  1 — '  1  \  w    l  L— 

1 1/20/2012 

FDA/OC/OES/DDM/ 

HAMILTON  PHD  LEROY  L 

1   1  /  \  1  V 1  1  l__  1  Vw/  1  N    1     II  l_/  1    1  l_  ]  l  V_/  1  1  

GENERAL  DVC  CLASSIFICATION  QUESTIONAIRE  -  MEMO 
5/1 2  TO  PRESENT 

FDA/OMPT/CDRH/OCER/DFOI/ 

£.VJ  I  C    /  U  I  O 

FDA/DMPT/nnRH/nnFR/nFm/ 

1  ISA  R  MORHAN 

l_  1 0/  \  1  l  1 V 1  v_/  1  l  \J  t\  1  \l 

□rjr.HF  DIAnND^TinS  -  nDARI  IP.HFK  X'1?  PI  1  IS  SY^  APPI 

1  l  v_/  w  1  1 1       LJ  \  f\\J  \  \  Vw/ O  1  1  Vw/O                        \J  \_/ 1  II  1  \  /v  O  1    LU  O  O  I  O  /  » 1    1  l_ 

11/20/2012 

ALERE  DAN  DIEGO  INC 

CLIA  WAIVER 

2012-7619 

l_  \_/  i  £_    /  v/  i  \j 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  lw/  1  1  1/  > — /  III    /  1 — /  1  !_/  1  / 

FRANCIS  HY  GREEN  MD 

1    1  1 1  V 1  N  V/  1  \J    1   1   1           1  1 1  1  1  M    1  V 1  I—/ 

ALLIANCE  PHARMS  -  IMAGENT  Gl  PI 

1  \  1  1  1  /  \  1  M  Vw/  l_    1     1   1 V  \  1  1 1  V 1  Vw/        1  1  VI/  V  Vw-^  l_  1  VI  1     Vwi  1    1  1 

1 1/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      1  /  \_S  1— /  1  1  1/  V/  III    /  1— '  1  1— '  1  / 

UNIV  OF  CALGARY/DEPT  OF 

1^/  1  M  1  V     Vw/ 1      Vw//  V 1  V^l  1  \  1  1  1  /  !_/  1  1      1     Vw/  1 

FDA/OMPT/CDER/ORP/DIDP/ 

PATHOLOGY  &  LABORATORY 
MEDICINE 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7620 

10/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ELISA  TOSTADO 

HARMONIC  ACE  -  5MM  DIAMETER  SHEARS  23  K1 20729; 

11/20/2012 

STRYKER  SUSTAINABILITY 
SOLUTIONS 

HARMONIC  ACE  -  LAPAROSCOPIC  5MM  DIAMETER 
SHEARS  36  CM  LENTH  ADAPTIVE  TISSUE  TECNOLOGY 
K121550 

2012-7621 

L_  \_/   1  L_     /   V/  L_  1 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \  '  1— /  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

WARREN  WILLIAMS 

V  V  1  \  1  1 1  1 1  IN    V  V  1  1  1  1 1  \  \  v  1  Vw^ 

LINZESS  (LINACLOTIDE^  CAPS  NDA  202-81 1  APRVL  RECS 

1  1  1  VI L  l__  \_)  U    1  1—  1  1  M 1  \  Vw /  L_  Vw/  1   1  1  /  1      J    Vw//  \  1     Vw/    1  VI  1—/  /  \       V/  L_    \J  1    1     /  V 1     1  I  V  ^   1  1 1— —  Vw/  V/ 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOREST  RESEARCH  INSTITUTE 

8/30/12 

2012-7622 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L- /  1  1  1/  V_/  III    /  1 — /  1  J  /  1  / 

MARIA  RUFRANO-WILSON 

1  V  1 1  \  \  1 1 1  V   1  1  K-i  \     \  \l  VI  N  Vw/     V  V  1  I—  ^/  Vw/  1  >l 

KINRAY  INC  -  LABELER  CODE  63777 

1  V  1  1  VI  1   L 1  \  1     1  1  VI  Vw/        1  /  \  1  '  1  l_  l_  1  1    Vw/  Vw /  1 — '  l_   V/  \J  fit 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CARDINAL  HEALTH 

2012-7623 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L- /  1  1  1/  V_/  III    /  lw/  1  ]  /  1  / 

GEORGE  SHAMSOUN 

V_*1  1— —  Vw/  1   1  Vwi  1        \—/  1   1  /  \  1  V 1  VwJ  Vw/  kw7  1  N 

PRE-PEN  -  NDA  05-1 14  APRVL  RECS  REVIEWER'S  NOTES 

1     1  1 1        1     l__  1  VI         1  N  (_/  /  V  \J\J     \    \     \    1  \  \     \   1  V  L-    1   1  1  Vw/  VtJ  ^    1  1 1— —  V  1  1— —  V  V  1  1  I  Vw/    1  V|  Vw/  1  1  Vw/ 

1 1/20/2012 

i  it  [—  v// 1 —  v/  i  c — 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

METHAPHARM  INC 

2012-7624 

10/22/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 

CAMPBELL  CO,  CAMDEM,  NJ  -  RECS,  RESULTS  2008  TO 

Page  53  of  895 


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Control  # 

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Action  Office 

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Subject 

12/03/2012 

DO/NWJ-CB/ 

GISSENDAMMER,  ROBIN 

2012 

2012-7625 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

JAMES  A  LOCHRIDGE  JR 
PREIS  &  ROY 

CREATIVE  COMPOUNDS  LLC  -  RPTS,  TEST  RESULTS, 
PHOTOGRAPHS  ETC  1/10  2/10  (CERTIFIED^ 

2012-7626 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

STACI  M  TROLIAN 
BIOMET  INC 

DR  MARK  PHILLIPS  FRIGGLE  -  WARNING  LTR  CORR,  RECS 

2012-7627 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 
OM/OMP/DODIW 

NICKERSON  HILL 
ALLERGAN  MEDICAL 

ANULEX  TECHNOLOGIES  -  INSP  8/23/1 0-9/22/1 0,  WARNING 
LTR  RESP  3/3/1 1 ,  FDA  RESP  TO  K1 1 1 261  6/20/1 1 ,  ETC 

2012-7628 

10/22/2012 

1  \JI  i—£—i  t—\J\i— 

11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

CHRISTINA  M  MIRACLE 
HILL-ROM 

HILL-ROM  INC  -  K001 01 9  K001242  K003335  ETC 

2012-7629 

10/22/2012 
11/20/2012 

FDA/OF/CFSAN/OCD/EOS/ 

AHRENS,  AMY 

GENETICALLY  MODIFIED  CORN  -  BT  BACTERIUM  RECS 

2012-7630 

10/22/2012 
11/20/2012 

CVM/OCD/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

STEVE  D  MATTERI 

CONTEMPORARY  PRODUCTS 
INC 

SICHUAN  LONG  MARCH  PHARMACEUTICAL  CO  LTD, 
SICHUAN,  CHINA  -  EIRS  9/9-15/09.  9/19-22/11 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


2012-7631 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DOUGLAS  M  BLUE  II 
ZETETIC  INC 

MARS  CHOCOLATE  PRODS  ENTRY  #30070573942  - 

RECS 

2012-7632 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DOUGLAS  N  BLUE  II 
ZETETIC  INC 

MARS  CHOCOLATE  PRODS  ENTRY  #30070573959  - 

RECS 

2012-7633 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

PAM  PUMMILL 

SYBRON  DENTAL  SPECIALTIES 
INC 

MINNTECH  CORP  -  RAPICIDE  OPA-28  K1 20306 

2012-7634 

10/22/2012 
11/20/2012 

OC/OCC/ 

JENNIFER  HSIEH 

HEALTHCARE  RESEARCH 
CONSULTING  GROUP 

SUPERNUS  NDA  DISCUSSION  -  TRANS  10/3/12 

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Total  Records:  9990 


Control  # 


Reed  Date  / 
Due  Date 


Action  Office 


Signature/  Requester 


Subject 


2012-7635 


2012-7636 


10/22/2012 
11/20/2012 


10/22/2012 
11/20/2012 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 


PFIZER,  PARKER-DAVIS  -  LYRICA  AERS,  CLNCL  STUDIES 


NICOLAS  635504,  ALBERT 


ARLENE  MORALES 
BURDOCK  GROUP 


PECAN  SHELL  FLOUR  -  RPTS 


2012-7637 


10/22/2012 
11/20/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


ULTRAM  (TRAMADOL  HCL)  -  RECS 


HENLEY  56354-1 12,  FRANK 


2012-7638 


10/22/2012 
12/04/2012 


FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

OM/OMP/DODM/ 

FDA/OMPT/CDRH/OCER/DFOI/ 


LUKE  VELDERS 
UNIVOF 

PENNSYLVANIA/ABRAMSON 
CANCER  CENTER 


RESEARCH  STUDIES  THAT  HAVE  BEEN  GRANTED  A 
WAIVER  OF  INFORMATION  CONSENT  THAT  ARE  INTHE 
EMERGENCY  MEDICAL  SETTING  PURSUANT  TO 
21CFR50.24  -  TITLE  OF  STUDY,  NAME  OF  INVESTIGATOR. 
EMAIL  ADDRESS,  ETC 


2012-7639       10/22/2012  ORA/ 

11/20/2012  ORA/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

FDA/OGROP/ORA/SW- 
FO/SWID/SWID-CB/ 


CLAUDIA  HORNBACK 
ROANOKE  TRADE  SERVICES  INC 


CHUENEG  INC  -  NOTICES  OF  FDA  REFUSAL  ENTRY 
53601525388 


2012-7640 

10/22/2012 
11/20/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

SAMUEL  F  COLIN  MD 
FIRST  MANHATTAN  CO 

LUITPOLD  PHARMACEUTICALS  INC,  SHIRLEY,  NY  -  483S 
1/1/10  TO  10/17/62 

2012-7641 

10/22/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

INDIVIDUAL  RECS 

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V_/Ul  ill  Ul  TT 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  ricLIUtJoLci 

OUUJtfOl 

Due  Date 

12/06/2012 

ALFB/ 

Doe  J 

2012-7642 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  I — f  I  L/  I  / 

.lillian  Kppnan 

Mil  CI  1  1    E  \  \j  \j  1  1  CI  1  1 

COMPOUNDED  PRODUCTS  -  AERS 

\-J\S  1 V  1  1     Vw/  <s  1  N  IS  1  IS    1     II V*/  IS  \J  v/  1  V_J        /  V 1  1  I 'S 

1 1/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \-S  IS  1  1  1/  W  III    /  I — '  1  L/  1  / 

Morp  Mana7inp 

1  VIU  1  \j    1  V  1  dvJ  \Jk£—  1 1  1  \-i 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  \S  III    /  IS  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7643 

10/22/2012 

ORA/ORO/DFI/ 

Vw /  1  1 1  \i  \S  1  l Vm//  1 — /  1  It 

fifpnhpn  Watson 

app  PHARMACEUTICALS  GRAND  ISLAND  NY  -  RECORDS 

/  V II       III  I  \  1  1 1  V  1 1  \  \—f  1  \S  1  1  umLU  j    Vw^  1  1  /  V 1  M  lw/    1  \S  I—/  V 1  >l  1 — /  ,    1  V|   1          11 1  V^s  V^/  1   I  IS  \S 

11/20/2012 

ORA/ORO/DFI/ 

The  Buffalo  News 

RELEASED  UNDER  FOIA  10/19/02-10/19/12 

2012-7644 

10/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

K904448 

11/20/2012 

FDA/OC/OES/DFOI/ 

CORIN  USA 

2012-7645 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  IS  1  ]  /  1  / 

Kii7?)nnp  O'fihpa 

WUi.Ul  II  1         Vw/  V — '  1  1  \J  CI 

NDA  20845  -  FORM  3542/3542a  FOR  PATENT  8  282  966  AND 

1  M  IS  I  \  uuU^v        1    Vw/  1  1 1  V 1   v/  v./     C—l  \J  v_y      L_  CI    1    Vw/  1  1    1    /  \  1  l_  1  M  1     \_)  ,  L—  V/  L_  ,  v/  V/  V/   /  VI  *J  1 — / 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FAEGRE  BAKER  DANIELS 

RELATED  CORR 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7646 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  1  1   If  W  III    /  I — '  1  J  /  1  / 

John  M  Nardo  MD 

W \J  1  1 1  1    1  v  1  .    1  *J  CI  1  Uv    1  V 1  IS 

PROZAC  -  INITIAL  MEDICAL  REVIEWS  1987 

1     1  l  Vw/  £  /  V  Vw/        II  ill  1  1 V  \  l_    IVI  1— —  L/  1  Vw / 1  \  l—    1  1 1— —  V  1  1      V  V  Vw/     1  C/  V/  / 

1 1/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  V/  Vw/ 1 V  1 1      1  /  \J  IS  1  1  1/  V_/  III    /  L/  1  IS  1  / 

.Inhn  M  NarHn  MD 

vJ  LJ 1  1 1  1      1  V  1  .    1  N  CI  1  UU    IVI  IS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7647 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Tom  Burton 

NECC,  FRAMINGHAM,  MASS  -  ALL  RECS  RE  NECC  AND 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

THE  WALL  STREET  JOURNAL 

MENINGITIS  OUTBREAK  (10/04/2012  -  PRESENT) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

FDA/OC/OES/ 

1  1— '  /    V   Vw/  Vw//   Vw/  I—  W 

OC/COS/OL/ 

OC/OCC/ 

OC/OL/ 

2012-7648 

10/22/2012 

1  \Jl  L—L—l  C—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \  '  L/  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

John  M  Nardo  MD 

\J  \J  1  1 1  1    1 V  1  ■    1  M      1  UU    1  V  1  \S 

PAXIL  -  INITIAL  REVIEWS  FOR  APPROVAL 

i    /  \/\  1 1—       1 1  *j  i  i  1 1  \  \      i  1 1_  v  1 1— _  v  v  Vw/  i   \s  i  i  /  v  i    i    i  i  Vw /  v  i  v  i  

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

John  M.  Nardo  MD 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7649 

10/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Kenneth  Douville 

MICRO-SPHERE  SA  -  QAP 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Vertex  Pharmaceuticals 

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 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

Incorporated 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7650 

L—\J    1  L—     1  \J\JW 

10/22/2012 

■   V//  L—L—l  L—\J    1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  L-/  1  L-/  1  / 

Jacnn  Srhn^hpl 

uaoui  I  Uui  ii  iciu^i 

NDA  19430  -  FORM  3542/3452A  FOR  PATENT  7449012 

1  ^1  IS  1  \     1  ^*TJU        1    Vw/  1  1 1 V  1    \-)  ^-J   l  L— :  \J    l  \-i  C—  1  \   1    V^/  1  1    1    1  \  1  1  Ivl      /  " "  v/  \J  1  L—  , 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \J  l—s  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FAEGRE  BAKER  DANIELS 

7794432,  8048035 

2012-7651 

C—  \_/    1  L—      1    \J\J  1 

10/22/2012 

■  V//  L—L—l  L—\J\C— 

ORA/ 

Ohri^tnnhpr  Wpavpr 

ST  JUDE  MEDICAL  SYLMAR  CA  -  483  EIR  EXHIBITS 

\j  i    yj  \s  is  i_  i  v  1 1  is  i  v_/ /  \  i  ,  Vw/  i  ^i  v  i  /  v  i  i ,  v_/ >  \      ^uu ,  I  1 1  i ,   ^—  /  \  i  1 1  is  i  i  \s 

11/20/2012 

ORA/ 

THE  WALL  STREET  JOURNAL 

2012-7652 

10/22/2012 

ORA/ 

ST  JUDE  MEDICAL,  SYLMAR,  CA  -  483  1 0/01/2012  - 

11/20/2012 

ORA/ 

RBC  CAPITAL  MARKETS 

10/19/2012 

2012-7653 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Dr.  Christopher  Wilson 
NovioSense  BV 

MEDTRONIC  CONTINUOUS  GLUCOST  MONITORING 
SYSTEMS  RE  PARADIGN  REAL-TIME  SYSTEM  AND 
GUARDIAN  REAL-TIME  SYSTEM  (P980022  S001  TO  S122) 

2012-7654 

10/22/2012 
11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    is  1  \l  \s  1  v  1 1     1  /  ys  IS  I  ii  1/  w  \w / 1_  i  1/  \S  I    Vw/  ii 

Mr  .luha-Ppkka  Nuutinpn 

1  v  1 1  ■   \J  U  1  1  d    1     vl\l\U   1  N  \A  \A  LI  1  Ivl  1 

Ozics  Oy 

K0909435 

i  vv/\_/v/v/iwv/ 

2012-7655 

10/22/2012 

1  V. '/  L—L—l  L—\J\L— 

11/20/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    \—J  / \  i  M/  Vw/  Vw/  l_//  l_  \S  *S/ 

Kpvin  Cnfildhprn 

■  vc?  vim  vjuiuu^ i  y 

Goldberg,  Kevin  1 

MONSTER  ENERGY  DRINKS  -  AERS  01/01/2004  -  10/20/2012 

1 V  1  Vw/  1  M  \S   1  1— —  1    1    1  1  N  1       1    I  \Si    1      IS  1    MINI  \  \—J         1  \  \—  1    I  \S    \J  \  I  \J  If  L—  \J         1^           1  V/  C—\JI  L—  \J  1  L— 

2012-7656 

10/23/2012 

1  \Jl  L—\Jl  L—\J  1  C— 

11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  \S  1    O  /  V 1  N/  \w/  Vw/  1 — /  /  l_  Vw/  *Sf 

Fdward  MrPikp 

1_  \JK  V  V  CI  1  \A    IVIvl     1 IVO 

Stifel  Nicolaus  &  Co 

niFT  PEPSI  -  CAERS  2004  TO  PRESENT 

iS  1  l_   1      1      1       1     \S  1          WM  1       1    I  V_/    L—  \J  \J "      1  Vw/    1      11  l_  V/  1— —  1  *l  1 

2012-7657 

10/23/2012 

1  V//  L—\Jl  L—\J\L— 

11/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw/  IS  1  11   1/  Vw/ \J  l__  1  1/  l_/  1    Vw/  1/ 

Clarirp  Arruda 

viui  iv>t/  ni  i  uuu 

Procedure  Products  Inc. 

K884885 

2012-7658 

10/23/2012 

1  \Jl  L—\Jl  L—\J  1  C— 

11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  Vw/  1    V/  /  V 1  M/  Vw/  Vw/  IS  t  1—  Vw/  U/ 

Brian  Hartman 

1  }  1  1  Cl  1  1    1   1  CI  1  11  1  1  Ql  1 

ABC  NEWS 

MONSTER  ENERGY  DRINK  -  AERS  01/01/2009  -  10/22/2012 

1 V  1  Vw/  1  M  U  1  1— —  1  1    1  1  V  1  1  I  V_H   1     L^/  1   1  1  1  *J  1  V        l  \  1— —  1  I  VwJ    V/  1  /  V/  1  /  L_  V/  V/  v/          1  V/  ^L—l  C—  v/  1  L_ 

2012-7659 

10/23/2012 

1  V//  L—\Jl  L—\J\L— 

11/21/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

1    ]  / 1  \!  Vw/  \J  1  1  Vw/  1    /  Vw/  1  It  \/  *s  1—    1    Vw//  / \  1  1  

DO/ATL-CB/ 

Tom mv  Rnttnm^ 

i  \j  1 1 1 1 1 1  y  is  v/ 1  Lv  1 1 1  o 

LifePoint,  INc. 

LIFEPOINT  INC  WEST  COLUMBIA  SC  -  EIR 

1  1  1    1  1     Vw/  1  1  N  1   1    1  1  i|  Vw/  .    V  V  1— —        1     WwLU  1 V  1  is  1 1  \ ,    \w*  Vw/        1  III 

2012-7660 

L—\J    1  L—     1  \J\J\J 

10/23/2012 

1  \Jl  L—\Jl  L—\J  1  C— 

11/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw /  1— /  1  11   1/  Vw/  Vw /  l_  1  1/  \S  1    Vw/  J/ 

Rarhpl  .Inhn^nn 

1   ICl.V-'l  1^1   <_/ V/ 1  II  1  Jul  1 

FOI  Services,  Inc. 

K121598 

1  V  1  C—  1       \J  v/ 

2012-7661 

C—  \_/    1   L—      /    V/V/  1 

10/23/2012 

1  V//  L—\Jl  L—\J\L— 

11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    \—J  / \  1  *!/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

Fdward  MrPikp 

1_  V^l  V  V  Cl  1  \A    1  v  1  \-f  1     1 1  \  V/ 

Stifel  Nicolaus  &  Co 

RED  BULL  -  CAERS  2004  TO  PRESENT 

1  1 1  1  >    \  )  Ks  1  1            V  '  1  \  \  1  I  \S   L—  \j  \J         1  Vw/    1     11  1  *w/  1  1  v  1 

2012-7662 

10/23/2012 

1  \Jl  L—\Jl  L—\J  1  C— 

1 1/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  \w/  1         1  V 1  M/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 

1_  VJ  V  V  Cl  1  \A    IVIvl     1 1  \0 

Stifel  Nicolaus  &  Co 

ROCKSTAR  ENERGY  -  CAERS  2004  TO  PRESENT 

1  l  Vw/  \S  1  \W  1  /  V 1  I    1  1  *J  1  1   1  V_/   1          V_/ /  \  l_  1  I V/   L_  \J\J^X     1  Vw/    1     11 1_ \J  l_  1  >l  1 

2012-7663 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

GOLDMAN  SACHS 

ENERGY  DRINKS  -  FIVE  HEALTH  CASES  REFERENCED  BY 
NEW  YORK  TIMES 

2012-7664 

10/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

BLA  103949  S5153 

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Reed  Date  / 
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Action  Office 

Signature/  Requester 

Subject 

11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7665 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Fdwarri  MrPikp 

1_  v^/l  V  V  d  1  VJ    Ivlul     1 1  VVw< 

Stifel  Nicolaus  &  Co 

COCA  COLA  COKE  DIET  COKE  ETC  -  CAERS  2004  TO 

v/  Vw/  V-/ 1  \  Vw /  Vw/  i_y  \ .  \j  Vw/ 1  \  i  ,  \—/  1 1_  i    \j  Vw/ 1  \  i  .   i      i  Vw/       Vw/  /  v  i_  i  i  Vw/  l_  \j  \j  \     i  Vw/ 

PRESENT 

2012-7666 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  \w/  1    v//\  1  N/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 
Stifel  Nicolaus  &  Co 

MOUNTAIN  DEW  -  CAERS  2004  TO  PRESENT 

1 V  1  Vw/  Vw/  1  M  1  /  V 1  1  >J    ]  /  l_  V  V         Vw/  /  V  l_  1  I  Vw/   L_  V/  V_/         1  v/    1     1  1 1— —  Vw/  l_  1  M  1 

2012-7667 

10/23/2012 
11/21/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

1    L/  /  V/  Vw/  \J  1  1 W  1    /  Vw/  1  1/  V/  1  vj  l_    1    V-/  1  1  1  V  V  1  

DO/NWE-CB/ 

Rarhpl  Johnson 

1  IClVuil  lul   Uvl  II  IOUI  1 

FOI  Services,  Inc. 

GENZYME  FRAMINGHAM  MA  -  483  EIR  CORR  2005' 

1  I  M          1  1 V  1  1— —  ,11  1 1  \  \  V 1  1  1  V  Vw/  |   |  /  V 1 V 1  ■    1 V 1 1  \            V/  V/  ,    l_  II   1  ,    Vw/  Vw/  1  1 1  1  L_  V/  \_/  v./  , 

GENZYME,  ALLSON  LANDING,  MA  -  483,  EIR,  CORR  2005 

2012-7668 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  1  \l  Vw/  1    /  \w/  1    V/  /  \  1  >!/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 

1_  V^l  V  V  CI  1  \A    IVIvl     1 1  VVw* 

Stifel  Nicolaus  &  Co 

DR  PEPPER  -  CAERS  2004  TO  PRESENT 

L/  1   V    1  1— —  1     1     l_  1  1        Vw/  /  \  1  1   I  Vw/  £_  V/  W    i      1  Vw /    |     |  1 1  \_J  1  1  N  1 

2012-7669 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    1  /  /  V/  Vw/  1    /  Vw/  1    ^/  J  \  \  Mi  Vw/  Vw/  L//  l_  Vw/  V-// 

Fdward  MrPikp 

1_ V^/l  V V  CI  1  \A    1  v  1  \-f  1     1  l\U 

Edward  McPike 

MONSTER  ENERGY  DRINKS  -  AERS 

1 V  1  Vw/  |  V|  Vw/   |    l__  |    I    I  |  *J  1  I   1  V_/    |      |_/  I    MINI  V  Vw/         I  \  l_  1    1  Vw/ 

2012-7670 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  V/  1    v//\  1  >J/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 

1_  V^l  V  V  CI  1  \A    IVIvl     1 1  VVw* 

Stifel  Nicolaus  &  Co 

STARBUCKS  -  CAERS  2004  TO  PRESENT 

Vw/  i  /  \  i  1 1  t  \s  Vw/ 1  v  Vw/       v/  /  \  i  i  i  Vw/      v/  v/       i  Vw/  i    it  i_  Vw/ 1_  i  vi  i 

2012-7671 

L_  v/   1  £_     1   \J  i  1 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    L/  /  V/  Vw/  1    /  Vw/  1    Vw/ /  V 1  Mi  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

FORBES  MAGAZINE 

MONSTER  ENERGY  DRINKS  -  DEATH  REPORTS 

1 V  1  Vw/  1  VJ  Vw/  |  l__  |  I    I  |  1|  I  |  |  V_/   1      L/  1   11  1  vj  |  V  Vw/        L/  1  /  \  1  1   1    1  1 1_  1  Vw /  |  |  |  \tj 

2012-7672 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  l — /  /  V/  Vw/  1    /  V/  1    v/  /  \  1  M/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 

1_  V^l  V  V  CI  1  \A    IVIvl     1 1  VVw* 

Stifel  Nicolaus  &  Co 

5  HOUR  ENERGY  PRODUCTS  -  CAERS  2004  TO  PRESENT 

\J    1   1  Vw /  Vw/  1  l    1  1  V|  I  |  1  Vw/   |      |     |  1  Vw/  1 — /  V/  V/  |  Vw/  Vw /  /  \  l_  1  I  V_/   £_  V/  V/         1  Vw/    1     11 1_  Vw/  l_  1  V|  1 

2012-7673 

10/23/2012 
11/21/2012 

FDA/0GR0P/0RA/0R0/DI0P/ 

Frank  Bednarz 
GOODWIN  PROCTER  LLP 

IMPORTATION  OF  DESMOPRESSIN  DRUG  PRODUCTS  SENT 
BY  FERRING 

l— J  1     1    1  1  11  1 1 1  vj  V_/ 

2012-7674 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

EMILY  MADOFF 

WOLF  POPPER  ROSS  WOLF  & 
JONES,  L.L.P. 

CORR  RE  WARNING  LTR  9/7/12  TO  LANCOME  USA 

2012-7675 

10/23/2012 
11/21/2012 

CVM/OCD/ 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

ADAM  DIEDERICH 
SCHIFF  HARDIN  LLP 

PATRON  FARMS  LLC,  CANFIELD,  OH  -  NON  COMPLIANCE 
RECS  INVESTIGATIONS  WARNING  LTRS  SINCE  1/09  TO 

1  1 1  V/  \-J  ,    1 1  v|  v  1— —  Vw/  1  1  V_/  /  V  1  1  Vw /  |  vj  Vw/  ,    V  V  /  \  1   1 1  v  1 1  vj  Vw/    1      |  |  I  Vw/   Vw/  1 1  vj  Vw/  1         I  i  \J  \s     1  Vw/ 

PRESENT 

2012-7676 

10/23/2012 
11/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

JUSTIN  LOVELACE 
TELEFLEX  MEDICAL 

PARKER  MEDICAL  INC  -  FLEX  TIP  TRACHEAL  TUBE 
K984528;  K1 00546 

2012-7677 

10/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  v/  L/  1  1  1/  V_/  III    /  t — /  1  1  /  1  / 

FDA  SMG  4850  7 

1  1— / 1    \      U  1  V  1  Vwl      ^\J\J\J  m  1 

1 1/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Svnprnv  Pharmacputicate  nc 

2012-7678 

10/23/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Kristy  A.  Schlesinger 

MONSTER  ENERGY  -  COMPLAINTS  OF  INJURY/DEATH 

Page  58  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

11/21/2012 

Kristy  A.  Schlesinger 

2012-7679 

10/23/2012 

1  \JI  L—\JI  t—\J  1  C— 

11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  \J  1    Vw^  1  V 1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  V_// 

Kri^tv  A  Srhlp^innpr 
Kristy  A.  Schlesinger 

STARBUCKS  CAFFEINATED  BEVERAGE  -  COMPLAINTS  OF 

Vw/  i  i  \ \  i is  \s  v/ 1  v Vw/  v/ni   i   i  1 1  n  /  v  i  i  is  is  i     v  i  i  i / \ i         v/v/ 1  v  1 1    i  i  \  \  \  >i  i  v*/  v/ 1 

INJURY/DEATH 

2012-7680 

10/23/2012 

1  V//  C—\JI  t—\J\l— 

11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  Vw/  1    ^w* /  V 1  VI/  Vw/  Vw/  L//  l_  Vw/  V-// 

Kri^tv  A  Srhlp^innpr 

1  V 1  IOLV    ' *  ■    VJvl  1 IUOI 1  1  VwJ  V-/  1 

Kristy  A.  Schlesinger 

RED  BULL  ENERGY  BEVERAGE  -  COMPLAINTS  OF 

1  1 1  Ly    1  )  Ks  1  1       1  1  N  1  1   1  Vw/    1     1  }  1—  V  1— —  1  1  / \  *S\  1             Vw/  Vw/  1  V 1 1     1  / \  Mil  V/  Vw /  1 

INJURY/DEATH 

2012-7681 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  \w/  1         1  \  1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Kri^tv  A  Srhlp^innpr 
Kristy  A.  Schlesinger 

ROCKSTAR  ENERGY  BEVERAGE  -  COMPLAINTS  OF 

1  I  Vw/  V/  1  \v_/  1  /  V 1  I    1  1  V|  I  |   l\Sl  1     1  )  \       V  1— —  1  1 1  \  \S\  \             \S  Vw /  1 V  1  1     1  /  \  Mil  Vw/   V/  1 

INJURY/DEATH 

2012-7682 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    ^w* /  V 1  VI/  Vw/  Vw/  L//  l_  Vw/  V-// 

Kri^tv  A  Srhlp^innpr 
Kristy  A.  Schlesinger 

FULL  THROTTLE  ENERGY  BEVERAGE  -  COMPLAINTS  OF 

i       i_ i_    i  i  1 1  i Vw/  i   i  i  i      i__  i  vi  i  i  i v/  i    is  i  v  i— _  i  inv/  i           v/ Vw / 1  v 1 1    i_/  \  1 1  \  i  Vw/  v^/ 1 

INJURY/DEATH 

2012-7683 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  Vw/  1    V/ 1  \  1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Kri^tv  A  firhlp^innpr 

i  \ i  i o Ly  '  * -  ooi  i iuoi i  i \ v./ 1 

Kristy  A.  Schlesinger 

AMP  ENERGY  BEVERAGE  -  COMPLAINTS  OF 

/  \  i  v  1 1     i_  i  vi  i  i  i  \s  i    i  1 1_  v  I— _  i  i  /  \      i            \s  v/ 1  v  1 1    i_y  \  1 1  vi  i  v_/  Vw/ 1 

INJURY/DEATH 

2012-7684 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    ^w* /  V 1  Mi  Vw/  Vw/  L//  l_  Vw/  V-// 

Kri^tv  A  firhlp^innpr 

1  V 1  1 0  Ly   /»  m   w^l  1 IUOI 1  1  VwJ  W  I 

Kristy  A.  Schlesinger 

5  HOUR  ENERGY  -  COMPLAINTS  OF  INJURY/DEATH 

S    1   1  Vw /  Vw^  1  l    1  1  >l  1  1  l  V_/   1            w  Vw/  1 V 1  1     l_/  \  1  1  V|  |  Xw/  Vw /  1       1  1  Mu  lS  III/  IS  1  /  \  III 

2012-7685 

10/23/2012 

1  \JI  L—\JI  t—\J  1  1— 

11/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw /  lw/  1  11   1/  V_/  \  '  l_  1  1/  \S  1    Vw/  1/ 

An3  Mlin^r 

1  \  \  1  CL   1  v  1 1 1 1  lul 

MESI,  d.o.o. 

K1 03693 

1  \  1  V/UUi/iJ 

2012-7686 

10/23/2012 
11/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Lara  Yunaska 
INSIDE  EDITION 

MONSTER  ENERGY  DRINKS  -  AERS  2007  TO  PRESENT 

2012-7687 

10/23/2012 
11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  IS  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

Jonathan  Rockoff 

THE  WALL  STREET  JOURNAL 

NEW  ENGLAND  COMPOUNDING  CENTER,  AMERIDOSE, 
ALAUNUS,  ETC  -  WARNING  LETTERS,  483,  ETC  (01/01/1980 
-  10/22/2012) 

2012-7688 

10/23/2012 
11/21/2012 

FDA/OC/OES/ 

0C/C0S/0L/ 

OC/OCC/ 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Todd  Wallack 
BOSTON  GLOBE 

NEW  ENGLAND  COMPOUNDING  CENTER,  AMERIDOSE, 
ALAUNUS  PHARMACEUTICAL  --  COMPLAINTS, 
INSPECTION  RECS,  CORR,  ETC  (01/01/2002  -  10/22/2012) 

Page  59  of  895 


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Subject 

OC/OL/ 

2012-7689 

10/23/2012 
11/21/2012 

FDA/OC/OES/DFOI/ 

NICHOLS,  JARROD 

INDIVIDUAL  RECS 

2012-7690       10/23/2012  FDA/OMPT/CDER/ORP/DIDP/ 
11/21/2012  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/ 
OC/COS/OL/ 
OC/OCC/ 
ORA/ 
ORA/ 
OC/OL/ 


JUSTIN  A.  BROWNE,  Esq. 
JANET,  JENNER  &  SUGGS,  LLC 


NEW  ENGLAND  COMPOUNDING  CTR  -  NVESTIGATION, 
WARNING  LTR  CORR,  FUNGAL  MENINGITIS  OUTBREAK  OF 
2012  RECS,  TEST  RESULTS 


2012-7691 


10/23/2012 
11/21/2012 


2012-7692  10/23/2012 
11/21/2012 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

OC/OCC/ 

ORA/ 

ORA/ 

OC/OL/  

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


SEAN  HIGGINS,  Esq. 
ANDREWS  &  THORNTON 


NEW  ENGLAND  COMPOUNDING  CTR  -  MENINGITIS 
OUTBREAK  RECS,  MENINGITIS  OUTBREAK  FROM 
METHYLPREDNISOLONE,  STERIOD  INJ  AERS,  ETC 


ISRS  2000  TO  PRESENT  -  RPT  TYPE,  GENDER,  MFR,  ETC 


CORRENS,  DOERTE 


2012-7693       10/23/2012  FDA/OMPT/CDER/ORP/DIDP/ 
11/21/2012  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


ISR  39770970001 


SHIPMAN,,  KIM 


2012-7694 


10/23/2012 
11/21/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


CMPLNT 


Doe  J 


Page  60  of  895 


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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  »  I  \i  V_/ 1  v  1 1     1  /  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7695 

10/23/2012 

1  \JI  L—\JI  t—\J  1  C— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \J  LJ  1  11   1/        VJ  l_  1  1/  1 — /  1    Vw/  1/ 

JOHN  D  BRANSON 

\J  \-s  1   1  1  VI  I — ^  ■    LJ  1  1/  VI  *J  Vw/  Vw/  1  VI 

MP70  INTELLIVUE  -  MDRS 

1 V  1  1     l  \J    \  \  H  \   1  1  1  1  V  VJ  1             1 V 1  LJ  1  I  VJ 

11/21/2012 

PARKER  POE  ET  AL  LLP 

2012-7696 

10/23/2012 

1  \Jl  L—\JI  L—\J\S— 

OM/OMP/DODM/ 

Vw /  1  V 1/  VJ  1 V 1  1    /  1  '  Vw/  J  /  1 V 1/ 

ANGEL  N  MOORE 

I  \  1  VI        1  l_    1  M  .    1  V 1  Vw/  V_/  1  1 1__ 

DOC  44  77N-0094 

11/21/2012 

HENRY  SPIEGEL  MILLING  LLP 

2012-7697 

10/24/2012 

FDA/OF/CFSAN/OOD/EOS/ 

1    LJ / V/  Vw/  1    /  VJ  1    UniM/VvL'/  1  VJ"VJ/ 

BILL  KIRK 

1  )  \  1  1      1  \l  1  1 1  \ 

MONSTER  BEVERAGE  CORP  -  AERS 

1 V  lv_/  1  Vl  vJ  II  II    1—/  1       VI  1  1 1  \       1        VJVJ  1  1 1           1  \  \  1  1  VJ 

11/22/2012 

Bill  Kirk  c/o  UBS 

2012-7698 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  \w/  1  v  1  1      1  /  V  '  LJ  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

Annplia  Rlpivton 

ni  luuna  vj  id  y  iwi  i 

NDA  21660  S  31 

1  M  LJ/  V  1—  1  \J\J\J    VJ  vJ  1 

1 1/22/2012 

1    1  /  C—L—l  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  VJ  l_J  |  |  1/  V_/  III    /  |_/  |  i  1 1  / 

iMr;  RESEARCH  CONSULTING  X 

1 1  >J  VJ   1  1 1  vJ  1  r\\  1U  1  1   VJ  VJ1  1  M  vJ  VJ  1      1  1 1  N  VJI  Ul 

FDA/OMPT/CDER/ORP/DIDP/ 

SUBMISSIONS 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7699 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Tom  Burton 

NEW  ENGLAND  COMPOUDING  CENTER  -  CORR,  MEMOS, 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

THE  WALL  STREET  JOURNAL 

INSPECTIONS,  ETC  (12/05/2006  -  10/03/2012) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

oc/occ/ 

V-/  VJ/  VJ'VJVJ/ 

ORA/ 

ORA/ 

OC/OL/ 

901  9-7700 

C.KJ  I  C.    1  1  \J\J 

1  n/?4/?ni  ? 

FnA/nMPT/rnRH/DPFR/nFni/ 

V i  ian  1  iann 
Audi  i  i_icu  ly 

pqi nnfifi 

^  H  /OO  /OA  ^  O 

1 1/22/201 2 

Devon  Medical  Products 

2012-7701 

10/24/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

Fabian  Zaccardo 

PROFESSIONAL  COMPOUNDING  CENTER  OF  AMERICA, 

1 2/21/201 2 

DO/DAL-CB/ 

rHUrtbblONAL  CUMPUUNUINO 

HOUSTON,  TX  -  483,  EIR,  WARNING  LETTERS,  ETC 

FDA/OMPT/CDER/ORP/DIDP/ 

CENTERS  OF  AMERICA  (PCAA) 

(01/01/1990-  10/01/2012) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FnA/OMPT/nnFR/DRP/nmp/ 

i  vj r\i  v_/ivi n  i  /  vj \-J \  rv vj i  \  i  /  lj i lj i  i 

ORA/ 

ORA/ 

FDA/OGROP/ORA/SW-FO/DAL- 

DO/DAL-CB/ 

Page  61  of  895 


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Total  Records:  9990 


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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7702 

10/24/2012 
11/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Xuan  Liang 

Devon  Medical  Products 

P850007,  S14,  S16,  S17 

2012-7703 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Pa(-|<pr  Thpuninrk 

1     dl  l\ w  1      III  \j  LJ  1  III  1  V-/l\ 

Meagher  &  Geer,  P.L.L.P. 

ALAVEN  PHARMACEUTICALS  LCC  -  CORR  RE  REGLAN 

/  V  l—/  \  V  1  1  >J    1     II 1  V 1  1 1  V  1 1  \  \w/  1  U  1  1  Vw/ 1  \  L_  O  .    1_  Nw^  \_J        \J  \s  1  I  1  I    II  l_    1  1 1  V^l  I  1  \  \  \ 

INVESTIGATION,  BOXED  WARNING 

2012-7704 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

Kathleen  McNerney 
WBUR 

NEW  ENGLAND  COMPOUNDING  CENTER  -  CORR  WITH  FDA 
01/01/1999-  10/23/2012 

2012-7705 

10/24/2012 
11/22/2012 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

Frank  Truslow 
INDIVIDUAL 

ENDO  HEALTH  SOLUTIONS  HUNTSVILLE,  AL  -  INSPECTION 
RECS  09/01/2010  -  12/31/2012 

2012-7706 

10/24/2012 
1 1/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  >  1  \!  \w/  1  v  1  1      1  /  \  '  Lri/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

OM/OMP/DODM/ 

marjo  gazak 

ELI  LILLY  AND  COMPANY  - 

l_  1  1    1  1  L_  L_  1     I  \  1  N  Lh'    Vw/  \w -*  1 V 1  1     i  \  1  *l  1 

PHARMACEUTICAL  DIVISION 

NDA  020599;  PERIPHERAL  AND  CNS  DRUGS  ADVISORY 
COMMITTEE  BRIEFING  MATERIALS,  MINUTES  09/18/95 

2012-7707 

10/24/2012 
11/22/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Alec  White 

HEALTHCOR  MANAGEMENT  LP 

PEPSI  CO  -  CAERS  (01/01/2004  -  10/23/2012) 

2012-7708 

10/24/2012 
11/22/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

Frank  Truslow 
INDIVIDUAL 

QUALITEST,  HUNTSVILLE,  AL;  QUALITEST,  CHARLOTTE,  NC 
-  WARNING  LETTER,  483,  ETC  (01/01/2009  -  12/31/2012) 

2012-7709 

10/24/2012 
11/22/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Alec  White 

HEALTHCOR  MANAGEMENT  LP 

COCA  COLA  -  CAERS  (01/01/2004  -  10/23/2012) 

2012-7710 

10/24/2012 
11/22/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Sharon  Riley 

CONSUMER  REPORTS  ON 
HEALTH 

NAIL  POLISH,  NAIL  POLISH  REMOVER,  ARTIFICIAL  NAILS, 
ETC  -  CAERS  (01/01/2011  -  1 0/22/201 2^ 

2012-771 1 

10/24/2012 
11/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Su^an  Anthonpv 

'JUiJUl  1  1  VI  ILI  Ivl  1  \*r  y 

AEGIS  REGULATORY  INC 

K1 20775 

2012-7712 

10/24/2012 

FDA/OC/OES/DFOI/ 

Tim  McGlinn 

2012-6462 

11/22/2012 

FDA/OF/CFSAN/OCD/EOS/ 

U.  S.  Steel  &  Carnegie  Pension 

Page  62  of  895 


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Fund 

2012-7713 

10/24/2012 
11/22/2012 

FDA/OMPT/CTP/OD/ 

MARK  E  GREENWOLD 

CAMPAIGN  FOR  TOBACCO- 
FREE  KIDS 

PHILIP  MORRIS  INTERNATIONAL  -  MODIFIED  RISK 
TOBACCO  PRODS  RECS 

2012-7714 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

NORBERT  GOTTESMAN 

AVET  CAPITAL  MANAGEMENT 
LLC 

AZACITIDINE  -  DISSOLUTION  TEST  METHOD  RECS; 
DECITABINE  INJ  -  BIOEQV  REQUIREMENTS 

2012-7715 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

AMLODIPINE  BESYLATE,  ASPIRIN,  JANUVIA,  ETC  -  AERS 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SCALES,  DESSIE  R 

2012-7716 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CHRISTODOULOPOULOS 

NDA  22-434/S012  -  RECS 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

VASSILIOS 

SANDOZ  CANADA  INC. 

2012-7717 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JUN  LIMLENGCO 

MCGUFF  PHARMACEUTICALS 
INC 

MYLAN  INSTITUTIONAL  LLC,  CO  GALWAY,  IRELAND, 
KILROE  EAST,  INVERIN,  ETC  -  EIR,  SUMMARY  RPT  3/12 

2012-7718 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JUN  LIMLENGCO 

MCGUFF  PHARMACEUTICALS 
INC 

BIONICHE  PHARMA,  KILROE  EAST,  INVERIN,  CO  GALWAY, 
IRELAND  -  SUMMARY  RPT,  EIR  10/09 

2012-7719 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CHERYL  A  FISHER 

HYCODAN  -  AERS,  MEDICATION  ERROR  RPTS 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TIANO  O'DELL 

2012-7720 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CHERYL  A  FISHER 

TUSSINEX  (TUSSIONEX)  -  AERS,  MEDICATION  ERROR 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TIANO  O'DELL 

RPTS 

2012-7721 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PATRICIA  L  REGENYE 

PHILIP  GOLD,  SWEDISH  CANCER  INSTITUTE,  SEATTLE,  WA 
-  EIRS,  483,  CORR  10/10  TO  PRESENT 

Page  63  of  895 


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Subject 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  \S  L/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Celgene  Corporation 

2012-7722 

10/24/2012 
11/22/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

PATRICIA  L  REGENYE 

1    1  \  1  1  l  1  V/  1 1  V   L   1  1 1  Vw4  1  1  M   1  1  

Celgene  Corporation 

STEPHEN  HANAUER  UNIV  CHICAGO  HOSPITAL  MED  CTR 

V/  1  1  1     1   1  1  1  M    1    1 1  \  \  *l  I  \  \—/  \  1  I ,    \—/  HIV    \J  1   1  1  V/ 1  V       \  '    1   1  V/  \_/  1     II  /  \  l_   1  v  1 1— —  l_/    V/  1  1  I  - 

CHICAGO,  IL  -  483  8/05  TO  PRESENT 

2012-7723 

10/24/2012 
11/22/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

PATRICIA  L  REGENYE 
Celgene  Corporation 

OLIVIER  RIXE,  UNIV  OF  CINCINNATI  CANCER  INSTITUTE, 
CINCINNATI,  OH  -  483S  1/03  TO  PRESENT 

2012-7724 

10/24/2012 
11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  t — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

PATRICIA  L  REGENYE 

1    i  \  1  1  l  1  V/  1 1  V   L   1  1 1  1  1  >l   1  1  

Celgene  Corporation 

ALESSANDRO  TESTORI  ISTITUTO  EUROPEO  Dl  1440 

/  \  1  1  \-J  \—>  t  \  \  N  1 — '  1  1  Vw/     1  l__  K-f  1  Vw/  III*    1  V/  1  1  1  \J  1  Vw/    l_  V/  1  1  Vw/  1     l__  Vw/    ]  /  1     1     i    i  w  , 

MILANO,  ITALY  -  EIRS,  483S,  CORR7/11  TO  PRESENT 

2012-7725 

10/24/2012 
11/22/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

1    1  /  /  V/  Vw/  Vw^  1  I  Vw/  1    /  Vw/  1  IV  V/  1    / \    1    Vw//  ^V/VJ 

DO/LOS-CB/ 

PATRICIA  L  REGENYE 

1    1  \  1  1  l  1  V/  1  /  V   L   1  1 1  Vw4  1  1  M   1  1  

Celgene  Corporation 

MARK  KIRSCHBAUM  CITY  OF  HOPE  NATIONAL  CANCER 

1 V  11  VI  1 1  \   1  \  1  1  1 V/  Vw/  1   1  1  '  J  \  \-J  \  v  1  -    V/  1  1     1     V-/  1      1   1  \h/  1  1— —    1  *J  /  \  1  1  Vw/  1  >l  /  V 1       V/  /  \  1  N  Vw/  1  1  I 

CENTER,  DUARTE,  CA  -  483S  4/09  TO  PRESENT 

2012-7726 

10/24/2012 
11/22/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

CHRISTOPHER  BRENNAN 
WESTLAW  COURT  EXPRESS 

SMITH  &  NEPHEW  -  BHR  BIRMINGHAM  HIP  RESURFACING 
SYS  PO40033  MEMOS  ETC 

2012-7727 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  L/  1  1  /  1  / 

PROMETHAZINE  -  MEDWATCH  FORM  3500 

1     1  l  Vw/  1 V 1  1— —  1  1   1 1  \L  1  1  N  1             1 V 1  1— —  L*S  V  V  /  \  1  Vw/  1   1    1    Vw/  1  1 1  V 1   Vw*  v/  V/  V/ 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-7728 

10/24/2012 
11/22/2012 

FDA/OF/CFSAN/OCD/EOS/ 

MARK  PIFKO 
BARON  &  BUDD  PC 

AVON  PRODUCTS  INC  -  ANEW  REVERSALIST  NIGHT 
RENEWAL  CREAM,  ANEW  ULTIMATE  7S  NIGHT  CREAM, 
SOLUTIONS  LIQUID  BRA  TONING  GEL,  ETC  RECS 

2012-7729 

10/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  (_/  1  L/  1  / 

c-rcp|_icM  q  MUMFORD  DRPH 

w  1  1  1     1   II  l\    1  '    1  V  1  VJ  1  V  1  1    Vw/  1  1  L/    1  '  1  11     1  1 

OUINAORINE  HCL  IND  74  802  -  EPIDEMIOLOGY  RVW  RECS 

Vj(  KJ  1 1  N 1  \  V/  1  1 1 1  M  1        1   1  \J  l_  j    \\H  l_/    /  T,Uvl_        1  1     1  l_/  1  1 VI 1  Vw/ 1  Vw/  V^   1     1  I  V  V  V    11 1  \J\J 

11/22/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

INTERNATIONAL  SERVICES 
ASSISTANCE  FUND 

2012-7730 

10/24/2012 
11/22/2012 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

GERALD  J  OREHOSTKY 
ANTARES  PHARMA INC 

PHARMACEUTICS  INTERNATIONAL  INC  -  EIRS,  483S  1/06 
TO  PRESENT 

2012-7731 

10/24/2012 
11/22/2012 

FDA/OC/OES/DFOI/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

ROBERT  P  CHARROW 
GREENBERG  TRAURIG  LLP 

W  L  GORE  &  ASSOCIATES  INC  -  GORE-TEX  TISSUE 
REINFORCEMENT  PATCH  K820193,  GORE-TEX  SOFT 
TISSUE  PATCH  K914449,  K930822,  ETC 

2012-7732 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Andrew  T.  Ryan 
Ryan  Law,  APLC 

BOSTON  SCIENTIFIC/GUIDANT  -  PACEMAKER 
INSPECTIONS;  GUIDANT  VITALITY  2  DR  ICD  IMPLANT 
MODEL  T1 65;  COMMUNICATIONS  RE  RECALL  ETC 

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Control  # 

Reed  Date  / 
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Signature/  Requester 

Subject 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OGROP/ORA/SE-FO/SJN- 
DO/SJN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7733 

10/25/2012 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V-/  III    /  l_/  1 1  '  1  / 

Wpnrlv  Ti3n 

vvci  iuv   i  icii  i 

NDA  20593  -  SBA 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

LUNDBECK  INC 

2012-7734 

10/25/2012 

1  \Jl  £—\JI  t—\J  1  £— 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  1— /  1  i  '  1  / 

Diana  Rnnpr^ 

ELECON  CREAM  NDA  REVIEWS 

1  I  l_  \w/  Vw/  1  N    V/  1  1  t  /  \  1  VI    1  >l  1 — '  1  \    1  1 1       V  1  1— —  V  V 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Diana  Rogers 

2012-7735 

10/25/2012 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    1  '  / V/  Vw/ 1 V  1  1      11  \J  1— /  1  1  1/  V-/  III    /  l_/  1  1  '  1  / 

Rarhara  Swift 

LJUI  WUI  U   V/VV  II  L 

TERIFLUNOMIDE  -  SBA 

1  1  1  1 1  1    1  KJ  1  >l  V_/  1  V 1  1  1 — /  l_        v^/  L//\ 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  FLORIDA 

2012-7736 

10/25/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1  1/  W  III    /  L*/  1  1  /  1  / 

Diana  Rnnpr^ 

L/ldl  IU    1   IUUUI  O 

ELOCON  OINTMENT  NDA  REVIEWS 

1  l_  Vw/  \w/  Vw/  1  *J    Vw/  1  1  VJ  1  1 V  1  1— —  1*11     IN  1 — /  /  \    1  1 1_  V  1  1      V  V  \—J 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Diana  Rogers 

2012-7737 

10/25/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  l_/  1  1  1/  V_/  III    /  !_/  1  1  /  1  / 

Diana  Rnnpr^ 

L/IUl  IU    1   IUUUI  O 

ELECON  LOTION  NDA  REVIEWS 

1  1  l_  V_y  V_/  1  ^|    l_  V  /  |   |  Vw/ 1  M    IN  l_/  / V    1  1 1       V  1  1      V  V  v/ 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Diana  Rogers 

2012-7738 

10/25/2012 
11/23/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Chris  Lahiff 

McDermott  Will  &  Emery  LLP 

MONSTER  BEVERAGES  -  AERS  (01/01/2004  -  10/24/2012) 

2012-7739 

10/25/2012 
1 1/23/2012 

1     1  /  L—  \JI  C—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L*S  1  1  1/  V_/  III    /  ( — /  1  J  /  1  / 

Tom  Burton 

THE  WALL  STREET  JOURNAL 

1  1   1  1— —    V  V  1  \  1  I       \-S  III  1— —  l_  1     \J  V^/  V/  1  1 1  4  /  \  1  

COMPOUNDING  PHARMACIES  -  EMAILS,  MEMORANDA, 
LEGAL  ANALYSES,  ETC  BETWEEN  OCC  AND  CDER 
COMPLIANCE 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/OCC/ 

Page  65  of  895 


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Control  # 

Reed  Date  / 
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Subject 

2012-7740 

C—  \J  \  C—    II  ""TV/ 

10/25/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  »  I  \i  V_/ 1  v  1 1     1  /  \J  IS  1  1  1/  W  III    /  !_/  1 1  '  1  / 

Ki  irt  Grpvp 

i\Ull  UICVC 

NDA  21817  S  12 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Kurt  W.  Greve 

2012-7741 

10/25/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  V  '  L*/  1  1  1/  > — /  III    /  1 — '  1  L— *  1  / 

Rnhprt  Dpfiaptann 

1  \\JVJ\j\  L  1— '  t*V_/  UU  LUI  IV/ 

METFORMIN  -  CLINICAL  STUDIES  RE  B12  DEFICIENCY 

1 V  1  1       1  1    Vw/  1  1 1 V 1  1  1  N        Vw/  ^  1  1  VI  1  Vw/  /  V  L_  \J  1  Vw/  IS  1  1  Vw/    1  1 1_    IS  1  L_  1 — /  l_  1    1  Vw/  1  1  1  M  Vw/  1 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Robert  DeGaetano 

2012-7742 

10/25/2012 

1  \JI  C—\Jl  t—\J\l— 

11/23/2012 

FDA/OC/OES/DFOI/ 

1    *S  1  \!  Vw/  Vw//  Vw/  1 —  VJ/  Lw*  1    VwX  1/ 

Danipl  Ralahan 

L/Ul  1  1      1    L/dlUUUl  1 

Daniel  Balaban 

MCNEIL  JOHNSON  &  JOHNSON  -  TYLENOL  INSPECTIONS 

1 V  1  Vw/  1  V|  l_  1  1_ .    \J  Vw/  1   1  1  XI  V/  V-/  1  N    t_X   W  Vw/  1   1  1  *|  \J  Vw/  |  \|          1     1   1  1  1  M  Vw/  1       1  1  M  V/  1     1  V-/  1  1  Vw/  1  N  Vw/  , 

RECALL  OF  2010,  RESPONSE  TO  INVESTIGATION,  ETC 

2012-7743 

L_  \_/    1  L—      1     1       1  *_/ 

10/25/2012 
11/23/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  v-/  L-/  1  11   1/  V_/  VJ  l_  1  1/  \S  1    \S  11 

Kpith  1  pland 

1  \t7  1  L  1  1    1  \J  IQI  1 V/ 

Preceptis  Medical,  Inc. 

K1 03595 

1  X  1  \J\J\J\J\J 

2012-7744 

10/25/2012 

1  \Jl  i—SI  L—\J\C— 

11/23/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \J  IS  1  11   1/  \s  \  '  1— —  1  1/  1  /  1    Vw/  1/ 

QIAGEN  SCIENCES 

GREINER  BIO-ONE  GMBH  -  EIR  (1/27/2003  -  01/30/2003^ 

1  1 1_  1  1  XI  1  1  l    IS  1  Vw/    Vw/  1  XI  l_    V_/  1  v  1  1  '  1   1         1  III    11/       *  1  £—  V/  V/  \w*        V/  1  /  \J\JI  L—  V/  V/  \»/  / 

2012-7745 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/PA-FO/SAN- 

i  i — ' /  v/  Vw/  v/ 1  i v_/ 1  /  Vw/ 1      \i  i   / \  i  \w//  \jni  xi 

DO/SAN-CB/ 

finnan  Diannp  1  upp 

» — '  UOUI  1    IS  1  OA  1  II  1 1»  1 — Uu^j 

Luce,  Susan  D 

PRIDE  OF  AMERICA  CRUISE  SHIP  HAWAIIAN  ISLANDS  - 

1     III  IS  l_   Vw/  1      /  \  1  V 1  1  1  1 1  Vw/  /  V  Vw/  |  1 V/  1  V/  1— —   V_/  1   1  1  1       II 1  \  V  V  1  V 1  1/  VI  XI    1  V/  1  /  VI  X|  IS  Vw/ 

MOST  RECENT  INSPECTION  REPORT 

2012-7746 

C—  \J  1  w-     1    1     i  \J 

10/25/2012 

1  \Jl  i—SI  L—\J\S— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L/  1  11   1/  Vw/  V  '  l_  1  1/  IS  1    Vw/  1/ 

William  A  Srofield  .lr 

K021736 

1  V  V/  L_  1  /  JU 

11/23/2012 

FDA/OC/OES/DFOI/ 

Lathrop  &  Gage  LLP 

2012-7747 

10/25/2012 

1  \JI  £—\J!  t—\J  1  t— 

11/23/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

1  1 — '  /  V/  V/  V/  1  1  V_/  1    /  V/  1  1/  v  1    *i    1    Vw//  LWW 

DO/LOS-CB/ 

QIAGEN  SCIENCES 

SCANTIBODIES  SANTEE  CA  -  EIR  2011 

Vw/  Vw/  /  VI  X|  |  |  IS  Vw/  lw/  1  1  V_/  ^    Vw/  /  VI  X|  |  I  1  j    v/  /  V        1  1  1  I  £_  V/  1  1 

2012-7748 

C—  \J  1  w-     1    1  V/ 

10/25/2012 

1  \Jl  i—SI  L—\J\S— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— /  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  11   1/  Vw/  Vw/  l__  1  1/  IS  1    Vw/  1/ 

William  A  Srofield  .lr 

V  V  1 1 1 1  d  1  1  1   i  *  ■    Uvv  1 1  V>  1 ,    VJ  1  ■ 

K003323 

11/23/2012 

FDA/OC/OES/DFOI/ 

Lathrop  &  Gage  LLP 

1  o 

2012-7749 

10/25/2012 
11/23/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

John  DeLucia 
ICAD  INC 

P100005/S001 

2012-7750 

L_ \J  1  w-     1    1  \J\J 

10/25/2012 

1  \JI  C—\Jl  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw/  IS  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

Rarhpl  .Inhn^nn 

1  IClVvl  lul   Uwl  II  IOV/1  1 

BLA  1 25276  S49 

is  i_y  \    i  l_  v/  l_  /  v/  Vw/  v/ 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1 V  1  1      1  /  W  L/  1  1  1/  Vw/  III    /  I — /  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7751 

10/25/2012 

ORA/ 

JULIA  KUFMAN 

\J  \w/  1  1 1  \   1  V  V/  I    I  v  1  /  V 1  M 

ST  JUDE  MEDICAL  ARECIBO  PR  -  483  MO/02/2012  - 

Vw/  1     Vv  Vw/  1  /  1— —    1  v  1  1  IS  1  \S  1  \  \  „    /  V 1  1 1— —  V/  1  IS  Vw/  ,    |     |l          i  VJ  w    l    IV//  \j  L—l  C—  \J  1  ww 

1 1/23/2012 

1     1  /  £ —  Xw/S  L —  \J    1  L — 

ORA/ 

RBC  CAPITAL  MARKETS 

10/02/2012) 

2012-7752 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

PHARMACEUTICAL  ASSOC  INC,  GREENVILLE,  SC  -  483  9/12 

2012-7753 

10/25/2012 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 

JOHNATHAN  RICKMAN 

CB  FLEET  CO  INC,  LYNCHBURG,  VA;  PHIPPS  &  BIRD  INC, 

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Control  # 

Reed  Date  / 
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Signature/  Requester 

Subject 

11/23/2012 

DO/BLT-CB/ 

FDANEWS 

RICHMOND,  VA;  INVITROCARE  INC,  FREDERICK,  MD  -  483 
9/12 

2012-7754 

10/25/2012 
1 1/23/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

JOHNATHAN  RICKMAN 

i — r~\  A    It  1  1 — 1  A  /o 

FDA  NEWS 

BLUE  ISLAND  PHENOL  LLC,  BLUE  ISLAND,  IL;  MEDGYN 
PRODUCTS  INC,  ADDISON,  IL;  RICHARD  WOLF  MEDICAL 
INSTRUMENTS  CORP,  VERNON  HILLS,  IL  -  483  9/12 

2012-7755 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARDINAL  HEALTH  414  LLC,  WEST  CHESTER,  OH;  KUTOL 
PRODUCTS  CO,  SHARONVILLE,  OH;  ME  AS  US  LLC, 
DAYTON,  OH  -483  9/12 

2012-7756 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

i  L-/ / v/  Vw/ i  iVj/ 1  /  Vw/ 1  in/  vJ  v  v  i      /  i— / 1  \ \  

DO/DAL-CB/ 

JOHNATHAN  RICKMAN 

\J       1  IIN/^  1  1  \r^\ M    1  1 1  \J  I \l  Vl/^l  N 

FDA  NEWS 

ISO  TEC  DIAGNOSTICS  INC  FRIENDSWOOD  TX  STJUDE 

1  w  W    1  1  W   1  '  ln>J  1  Nww  1  1  \_*  vJ   1 1  N  W  ,    1    1  1 1  1  IN  \—s  U  V  V  V_/V_/  \—s  ,     1  /  \  ,  v  )  1    \J  LJ  l_/  1  

MEDICAL,  PLANO,  TX  -  483  9/12 

2012-7757 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

AMERICAN  SLEEP  ASSOC  LLC,  CEDAR  CITY,  UT;  LED 
TECHNOLOGIES  LLC,  ELIZABETH,  CO  -  483  9/12 

2012-7758 

10/25/2012 
1 1/23/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

ELBA  INC,  TROY,  Ml;  BAXTER  PHARMACEUTICALS 
SOLUTIONS  LLC,  BLOOMINGTON,  IN;  AIRGAS  GREAT 
LAKES  LLC,  LANSING,  Ml  -  483  9/12 

2012-7759 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

VITAL  PHARMACEUTICALS  INC,  WESTON,  FL;  AMERICAN 
NATURAL  PRODUCTS  INC,  MIAMI,  FL;  INVIVO  CORP, 
ORLANDO,  FL  -  483  9/12 

2012-7760 

10/25/2012 

1  \JI  C—\Jl  t—\J\l— 

11/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JOHNATHAN  RICKMAN 

U  Vw/  1   1  1  N  /  \  1  1   1 1  \  1  il    111  \J  1  \  1  v  1/*  1  N 

FDA  NEWS 

PFIZER  HEALTH  AB  STRANGNAS  SWEDEN'  KANEBO 

1     1     1 L  l__  1  1    1   1  1  1  \  1       1  1   1    /  \  I  )  j    \J  1  1  il  VI  i|        1  4  /  \      ,    Vw/  V  V  1—  L*/  l_  1*1.    1  \  I  \  1  *l  1  I—} 

COSMETICS  INC,  ODAWARA  SHI  KANAGAWA,  JAPAN; 
AJANTA  PHARMA  LTD,  AURANGABAD,  INDIA  -  483  9/12 

2012-7761 

10/25/2012 
1 1/23/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

SEIKAGAKU  CORP,  IBARAKI,  JAPAN;  BPTRU  MEDICAL 
DEVICES,  COQUITAM,  CANADA;  SIGVARIS  DO  BRASIL, 
JUNDIAI,  BRAZIL  -  483  9/12 

2012-7762 

10/25/2012 
1 1/23/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARE  TECH  LABS  INC,  ST  LOUIS,  MO;  MGP  INGREDIENTS 
INC,  ATCHISON,  KS;  GLOBAL  MEDICAL  HOLDINGS  LLC, 
ADEL,  IA-483  9/12 

2012-7763 

10/25/2012 
1 1/23/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

BAXTER  HEALTHCARE  CORP,  LOS  ANGELES,  CA;  TITAN 
MEDICAL  ENTERPRISES  INC,  SANTA  FE  SPRINGS,  CA; 
IRENDA  CORP,  LOS  ANGELES,  CA  -  483  9/12 

2012-7764 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

STEUART  LABS,  MABEL,  MN;  PETNET  SOLUTIONS  INC, 
MINNEAPOLIS,  MN;  HYDRITE  CHEMICAL  CO,  MILWAUKEE, 
Wl- 483  9/1 2 

2012-7765 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARDINAL  HEALTH  414  LLC,  WOBURN,  MA;  APLICATE  INC, 
MERIDEN,  CT;  DAVOL  INC,  WARWICK,  Rl  -  483  9/12 

2012-7766 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

JAMES  ALEXANDER  CORP,  BLAIRSTOWN,  NJ;  LTS  LOHMAN 
THERAPY  SYS  CORP,  WEST  CALDWELL,  NJ;  WATER  JEL 
TECHNOLOGIES  LLC,  CARLSTADT,  NJ  -  483  9/12 

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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7767 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

DR  REDDYS  LABORATORIES  LLC,  SHREVEPORT,  LA;  ORAL 
DNA  LABS  INC,  BRENTWOOD,  TN  -  483  9/12 

2012-7768 

10/25/2012 
1 1/23/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARDINAL  HEALTH  414  LLC,  ROCHESTER,  NY;  CHARTWELL 
PHARMS,  CONGERS,  NY;  STERI  PHARMA  LLC,  SYRACUSE, 
NY -483  9/12 

2012-7769 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

HIGH  CHEMICAL  CO,  LEVITTOWN,  PA;  MERCK  SHARPE  & 
DOHME  CORP,  WEST  POINT,  PA;  GLYCADIA  INC, 
PHILADELPHIA,  PA  -  483  9/12 

2012-7770 

10/25/2012 

1  \JI  £—\J!  t—\J  1  £— 

11/23/2012 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CARDINAL  HEALTH  LLC  LAS  VEGAS  NV'  MIZUHO  OSI 
UNION  CITY,  CA;  OPTOVUE  INC,  FREMONT,  CA  -  483  9/12 

2012-7771 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/SE-FO/SJN- 
DO/SJN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

TAPI  PUERTO  RICO  INC,  GUAYAMA,  PR  -  483  9/12 

2012-7772 

10/25/2012 
11/23/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

WELCH  ALLYN  PROTOCOL  INC,  BEAVERTON,  OR  -  483  9/12 

2012-7773       10/25/2012  ORA/ 
11/23/2012  ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

 FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7774       10/26/2012  ORA/ 
11/26/2012  ORA/ 


JOHNATHAN  RICKMAN 
FDA  NEWS 


KASIOS  BONE  SUBSTITUTES,  LAUNAGUET,  FRANCE;  AUS 
SYSTEMS  PTY  LTD;  ALLENBY  GARDENS,  AUSTRALIA; 
STEELCO  SPA,  RIESE  PIO  X,  ITALY  -  483  9/12 


Amy  Birnbaum 
CBS  NEWS 


NEW  ENGLAND  COMPOUNDING  CENTER  -  483,  EIR, 
MEDWATCH  REPORTS,  ETC 


2012-7775 


10/26/2012 
11/26/2012 


ORA/ 
ORA/ 


LAZARD  CAPITAL  MARKETS 


STJUDE  MEDICAL,  SYLMAR,  CA  -  483,  CORR  (09/01/2012 
10/25/2012) 


2012-7776 


2012-7777 


10/26/2012 
11/26/2012 
10/26/2012 
11/26/2012 


FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OF/CFSAN/OCD/EOS/ 


Boehringer  Ingelheim 
Ricky  Campbell 
Register  Citizen  


GARY  SCHILLER,  UCLA  MEDICAL  CENTER  -  483  2001 ,  201 1 


ENERGY  DRINKS,  K2  -  AERS  IN  CONNECTICUT 


2012-7778 


2012-7779 


10/26/2012 
11/26/2012 
10/26/2012 
11/26/2012 


OM/OMP/DODM/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


Desmond  Jenson 

Tobacco  Control  Legal  Consortium 
Anna  Edney 
BLOOMBERG  NEWS 


FDA-2011-P-0573  -  COMMENTS  TO  DOCKET 


NEW  ENGLAND  COMPOUNDING  CENTER,  FRAMINGHAM, 
MA  -  AERS,  WARNING  LETTERS,  INSPECTION  REC 


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Total  Records:  9990 


\jU\  III Ul  tt 

MO  LIU  1 1  WIMOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  laLUl  u/  rlcLjUtJoLci 

OUUJtfOl 

Due  Date 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

2012-7780 

10/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rarhpl  Johnson 

1  IClVwfl  lul   \J\J\  II  IOVJI  1 

K071343 
i  \ \j  i  i  *j^\j 

11/26/2012 

FOI  Services,  Inc. 

201  2-7781 

Rwqn  Fnthprnill 
nyai  i  nuLiiciyin 

FDA  AnRFFMFNT^  WITH  IFH  INTFRNATIONAI  (n^/OM^ndQ  . 

1          \  /        1  1 1  1  1 V 1 1  W  1  O  VVI  1  1  1  1 1—  \  1  MM  1  I—  ll  1  <J  f  \  1  1  \J  1  N  f\  l_  \\J\Ji  \J  1  1  C.\J\Jij 

11/26/2012 

Primus  Labs 

10/2^/20121 

2012-7782 

10/26/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

M  ATU  A  Mid  1 —  K  |/"\  O 

NATHANIEL  ENOb 

\  /  a  i —  no     iMni\  /i  ni  i  a  i  r- > i —  o 

VAERS  -  INDIVIDUAL  RECb 

11/26/2012 

ALFB/ 

CONWAY  HOMER  &  CHIN- 

CAPLAN  PC 

201  P-778T 

1  l.    /  /  DO 

FDA/nF/r.F^AN/nnn/Fnc!/ 

I  vj  r\i  \j  i/  o  l  o/\  I  \i/  v_/\_/ 1—// 1  \w^O/ 

MARII  YNN  WHITNFY 

I  virA  n  1 1_  T  I  >i  I  >J  v  v  I  1 1  I  I N I   i 

MON9TFR  FNFRfiY  PROD^  -  CAFR^ 

11/26/2012 

COVINGTON  BURLING  LLP 

rtrtH  o   "7"70  j1 

2012-7784 

10/26/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

PATRICK  KELLY 

\  /  a  i —  no     iKini\/ini  i  a  i    n i —  o o 

VAERS  -  INDIVIDUAL  RECb 

11/26/2012 

ALFB/ 

CONWAY  HOMER  &  CHIN- 

CAPLAN  PC 

OrtH  O  "7"70£T 

201 2-7785 

10/26/2012 

rUA/Ur/0rbAN/UGD/EOb/ 

ANutLA  bMY  1  H 

OAtKb  157049 

11/26/2012 

I0VATE  HEALTH  SCIENCES 

INTERNATIONAL  INC 

2012-7786 

10/26/2012 

1  \JI  L—\JI  L—\J  1  £_ 

FDA/OMPT/CDRH/OCER/DFOI/ 

VINEET  SARIN  PHD 

V  M  *J  1  1       1               1  1  1  1  *J    1     II  1 — ' 

K954219  K954213  K922247  ETC 

1 1/26/2012 

KINAMED  INC 

I  \ 1 1  *j /  vi v 1 1— _ is  ii  i  Vw/ 

f\f\4  O  "7"70"7 

2012-7787 

10/26/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

WILLIAM  S  JOHNSON  RN 

i —  i  /~\ nin  a  r  ii i —  r~\ i /~i  a  i    o i  i  k  1 1 /~i   ~7 r~ nuvnu  1110  i —  i       a  i  ihit  o  if* /h  o 

FLORIDA  MEDICAL  CLINIC,  ZEPHYRHILLS,  FL  -  AUDIT  8/6/12 

1 1/26/2012 

DO/FLA-CB/ 

FLORIDA  MEDICAL  CLINIC 

1    LW  1  1  1  1 — '  i  \   1 V 1  1— —  IS  1  Vw/ 1  \  L_  \J  ^  1  1  N  1  \-S 

201  2-7788 

10/?fi/?01? 

FDA/OF/CF^AN/OP.n/FOC!/ 
i  vj  r\i  \j  1/  o  i  o/\  i  \i/  v_/\_/  vji  i  \w^o/ 

DONAI  n  F  ^FOAI  F^O 

L/UI  v/\  l_  VJ   \       O  1  \J  r\  l_  1  O  \J 

i  |cp  rjF  I  A^FR-FTCHINfi  TFCHNOI  OHY  ON  FOO'1?  AND  A 

UOI       Kj  1      LflOtn    1       1  W 1  1  1 1  \  \J\     1  tUni  NvLvVJ  1    WIN   1  \J  \J  O  i\  1  N  1— '  /  \ 

11/26/2012 

0C/C0S/0ES/ 

ALSTON  &  BIRD  LLP 

WALMART  PILOT  PROGRAM  PERMITTING  THE  REPACKING 

OF  EGGS  AT  THE  RETAIL  LEVEL  -  RECS,  CORR 

0C/C0S/0ES/ 

2012-7789 

10/26/2012 

ORA/ 

LEIF  LARSEN 

1  1  II      1  1  \  \  l \J  \  IN 

FRESH  HEMP  FOODS  LTD  -  HEMP  BLISS  (NON  DAIRY  HEMP 

1     1  1 1  \J  1   1    1   II  1 VI 1       1    \JKJ  1  '  w    1      1  LJ        1   II  1 VI 1       VJ  1  1  V  }  V  }    1  I  M  W  I  \|    L/nl  III     III  1 VI 1 

1 1/26/2012 

ORA/ 

CBC  MANITOBA 

BEVERAGE)  IMPORT  REFUSAL  RECS 

FDA/0GR0P/0RA/0R0/DI0P/ 

FDA/OGROP/ORA/CE-FO/MIN- 

UO/MIN-0d/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

2012-7790 

10/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JUSTIN  D  RIEGER 

POLYMEDIX  INC  -  PMX-60056  CLNCL  TRIAL  APRVL  RECS 

11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ROBBINS  UMEDA  LLP 

FDA/OMPT/CDER/ORP/DIDP/ 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7791 

10/26/2012 
11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

OC/OCC/ 

ORA/ 

ORA/ 

OC/OL/ 

SEAN  HIGGINS  ESQ 
ANDREWS  &  THORNTON 

ALANIS  PHARM  -  METHYLPREDNISOLONE  ACETATE 
MEMINGITIS  OUTBREAK  RECS  2012;  AMERIDOSE  LLC  - 
STEROID  INJ  AERS  1/12  TO  PRESENT,  ETC 

2012-7792 

10/26/2012 
11/26/2012 

ORA/ 
ORA/ 

OC/OER/OPA/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

J&J  MARKETED  VAGINAL  MESH  IMPLANT  WITHOUT  US 
Mr ririVJVML  -  L»vjriri  ^L/tri  1  \r\c.U) 

2012-7793 

10/26/2012 
11/26/2012 

ORA/ 
ORA/ 

OC/OER/OPA/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

J&J  SOLD  VAGINAL  MESH  IMPLANT  AFTER  SALES  HALT 
ORDERED  -  CORR  (CERTIFIED) 

2012-7794 

10/26/2012 

ORA/ 

KEVIN  STRANGE 

ST  JUDE  MEDICAL,  SYLMAR,  CA  -  483  9/25/1 2-1 0/1 7/1 2 

11/26/2012 

ORA/ 

WELLS  FARGO  SECURITIES 

2012-7795 

10/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PAMELA  SCHANEEN 

NAPRELAN  (NAPROXEN  SODIUM)  NDA  20-353  -  SBA 

11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHIONOGI  INC 

2012-7796 

10/26/2012 

ORA/ORM/ 

DAVID  MANGIONE 

483S  8/23/12-10/24/12 

11/26/2012 

ORA/ORM/ 

FDAZILLA 

2012-7797 

10/26/2012 
11/26/2012 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

ANDREW  HACK  MD  PHD 
MILLENNIUM  MANAGEMENT  LLC 

ST  JUDE  MEDICAL,  SYLMAR,  CA  -  EIRS,  483S,  WARNING 
LTRS,  ETC  1/12  TO  PRESENT 

2012-7798 

10/26/2012 
11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JUN  LIMLENGCO 

MCGUFF  PHARMACEUTICALS 
INC 

BIONICHE  PHARMA,  KILROE  EAST,  INVERIN,  CO  GALWAY, 
IRELAND  -  EIR  10/09;  MYLAND  INSTITUTIONAL  LLC,  KILROE 
EAST,  INVERIN,  CO  GALWY,  IRELAND  -  EIR  3/12 

2012-7799 

10/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALLISON  CHEN 

JENERIC/PENTRON  INC  -  QUELL  DESENSITIZER  RECS 

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Pnntrnl  if 

rit?0U  Udlc  / 

Due  Date 

MOLIUll  wlllUc 

OlyildLUlu/  r\t3L]UubLcr 

Ci  1  |[~li£!l/"»t 

ouujfcfoi 

11/26/2012 

FDA/OC/OES/DFOI/ 

HARVEST  CONSULTING  CORP 

2012-7800 

10/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  Vw/  1 V  1  1      1  /  \  '  L/  1  11   1/  V_/  \  '  l_  1  1/  1 — /  1    Vw/  J/ 

ALLISON  CHEN 

I  \  1  1  1  *s  Vw/  1  *J    V-/  1   1 1_  1  VI 

HERAEUS  KULZER  LLC  -  GLUMA  DESENSITIZER  POWER 

i  1 1  i  ii  \  i  *s  'S  i  \  VwV  1  /  i__  i  i  i_  i_  Vw/      v_h  i  iw/ 1  v  1 1  \  is  i—  Vw/ 1  i  ii  \w/ 1  i  i  ^  i  i  i  i  Vw /  v  v  i  i  i 

11/26/2012 

HARVEST  CONSULTING  CORP 

GEL  RECS 

2012-7801 

10/26/2012 

1  V//  L—\Jl  L—\J\l— 

11/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L_/  1  11   1/  Vw/  V  '  l_  1  1/  IS  1    Vw/  1/ 

ALLISON  CHEN 

I  \  1  1  1  \S  Vw/  1  V|    \S  1   1  1—  1  *J 

HARVEST  CONSULTING  CORP 

COLGATE-PALMOLIVE  CO  -  COLGATE  DESENSITIZING 

V_/  Vw/  L_  Vw^  /  V  1  1        1    I  \  L 1  V 1  Vw/  1  1  V  l_   \S  Vw/        V-/  V  /  L_  V  A 1  \  1  l_    IS  I—  Vw/  1  1  v  Vw/  1  1  1 Z  1 1  V|  V_/ 

DENTAL  CREAM  RECS 

2012-7802 

10/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALLISON  CHEN 

HOENIX  DENTAL  INC  -  SUPER  SEAL  TOOTH  DESENSITIZER 

11/26/2012 

HARVEST  CONSULTING  CORP 

RECS 

2012-7803 

L—  V/   1  £_     f  UUW 

10/26/2012 

1  V//  L—\Jl  L—\J\l— 

11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \s  1 V  1  1      11  \  '  L_/  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PETER  S  REICHERTZ 

1     1—  1  l__  1  l   Vw/    1  1 1_  1  Vw / 1   1  1  1  l  1  £  

SHEPPARD  MULLIN  RICHTER  & 
HAMPTON,  LLP 

AMAG  PHARMACEUTICALS  INC  -  FERAHEME 

/  VI V  1 1\  V_^    1     1   1 1  \  \  1 1 V  1 1  \  — /  l_  Vw/  1  1  \S  t  \  \  \S    1  1  VI  V/        1     1  1  If  V 1   1  1  1  v  1  1— — 

(FERUMOXTOL  INJ)  NDA  22-180  AERS  10/09  TO  PRESETN 

2012-7804 

10/26/2012 
11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L_/  1  1  1/  \s  III    /  1— /  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PETER  S  REICHERTZ 

1     1—  1  l__  1  l   \S    1  1 1__  1  Vw/ 1   1  1  1  l  1  ^  

SHEPPARD  MULLIN  RICHTER  & 
HAMPTON,  LLP 

WATSON  PHARMS  -  NULECIT  (IRON  GLUCONATE  &  FERRIC 

V  V  1  V  1  \_J  Vw /  1  VI    1     1   1/  VI  1 1  v  1  Vw/        1  V|  \J  l_  I  Vw /  II     l  1  1  l  V  '  1  V|    Vw/  1  Vw*  Vw/  Vw /  1  VI  /  \  1  l__    UV    1    l_  1  1 1  I  1  V/ 

GLUCONATE)  ANDA  78-215  SBA  10/09  TO  PRESENT 

2012-7805 

10/26/2012 
11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PETER  S  REICHERTZ 

i  i— _  i  i__  i  i  *s  i  1 1— _  i  Vw / 1  1 1  i  i  i  ^  

SHEPPARD  MULLIN  RICHTER  & 
HAMPTON,  LLP 

SANOFI-AVENTIS  -  FERRLECIT  (IRON  GLUCONATE  & 

U  /  VI  \  Vw/  1    1    /  V  V  1  1  \  1  1  \S        1     1  1  11  1 1—  1  Vw /  II     1  1  1  I  Vw/  1  V|    VJ  L_  Vw/  V/  V  '  1  VI 1  \  1  l_  LJV 

FERRIC  GLUCONATE)  NDA  17-44  SBA  10/09  TO  PRESENT 

2012-7806 

10/26/2012 
11/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \S  1 V  1  1      11  \  '  IS  1  1  1/  \S  III    /  IS  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \S  III    /  \S  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

PETER  S  REICHERTZ 

1     1—  1  l__  1  l    U    1  1 1__  1  Vw / 1   1  1  1  l  1  ^  

SHEPPARD  MULLIN  RICHTER  & 
HAMPTON,  LLP 

LUITPOLD  PHARMACEUTICALS  INC  -  VENOFER  (IRON 

1  V  '  III  Vw /  1  IS    1     1   1 1  \  \  1 1  VI/  V  Vw/  1— —  \-J  1  1  V  '  1  \  \  *S    1  1  VI  V  '         v  1  1  *J  Vw/  1    1  II    Till  Vw/  1  V| 

SUCROSE  INJ)  NDA  21  -1 35  SBA  1 0/09  TO  PRESENT 

2012-7807 

L_  \_/   1  £_     /  v/  *_/  / 

10/26/2012 
11/26/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

LnUI  11  In   w   1  ' I  \ 1  II  1 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  10/1-5/12 

1    Vw/  1    \S  1  \  \  \       1     1  \s  V-/     1  KJI    1     \JI    1  L— 

2012-7808 

10/26/2012 
11/26/2012 

FDA/OC/OES/DFOI/ 

1    *S  1  \!  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

L  1  \  \S  1  11  IN    \S    1  1 1  \  \  II  1 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  9/24-28/12 

1    Vw/  1    \S  1  \  \  \       1     l  Vw/  V^l    &f  t."T    L—\Ji    1  t_ 

2012-7809 

10/26/2012 
11/26/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  10/8-12/12 

2012-7810 

10/29/2012 

1  V//  t—  \//  t —  V/  1  l — 

FDA/OMPT/CDER/ORP/DIDP/ 

Ram  Mohan  Kathuroju 

ANDA  075753  -  SBA 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INVAGEN  PHARMACEUTICALS 
INC 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201 2-781 1 

10/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  VJ 1 V  1  1      1  /  W  U  1  1  1/  W  III    /  U  1  1  '  1  / 

JACOB  JACOBSEN 

\J  1  \  VJ  VJ  U  JmWWUUI  IN 

(;-HTP  -  AERS 

\J     1    1    1    1             1  \  1  1  IVJ 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  VJ  1  v  1  1      1  /  VJ  U  1  1  1/  V_/  III    /  t — '  1  U  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DUKE  UNIVERSITY 

2012-7812 

10/29/2012 
11/27/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Ricky  Campbell 
Journal  Register  Co. 

NATUREMOST  OF  NEW  ENGLAND,  MIDDLETOWN,  CT  - 
CORR  RE  WARNING  LETTER  (05/24/2012  -  10/25/2012) 

2012-7813 

10/29/2012 
1 1/27/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Barry  Meier 

New  York  Times  -Barry  Meier 

DIETARY  SUPPLEMENTS  -  AERS  (12/01/2008  -  10/01/2012); 
FDA  NOTIFICATION  OF  AFFECTED  COMPANIES  OF 
RECEIPT  OF  FATALITY 

2012-7814 

10/29/2012 
11/27/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

GRANDFATHERED  TOBACCO  PRODUCT  STATUS 
DETERMINATIONS  -  CORR,  DOCUMENTATION,  SUMMARIES 
(08/01/12  TO  10/29/12) 

2012-7815 

10/29/2012 
11/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  VJ  1  v  1  1      1  /  VJ  U  1  11   1/  VJ  V  l_  1  1/  1 — /  1    VJ  1/ 

Essex  Industries,  Inc. 

K833994 

2012-7816 

10/30/2012 

1  \Jl  \J\Jl  L—\J\t— 

11/28/2012 

FDA/OC/OES/DFOI/ 

1  1— '*V  WW/  VJ  1 —  VJ/  U  1     VJ  1/ 

Joan  Stitt  (UG2CD-16} 

UUul  1   VJLIIL   I  VJ  VJ L_ VJ  U     1  V/  1 

MERCK  &  CO.,  INC. 

2012-6222 

2012-7817 

10/30/2012 
11/28/2012 

FDA/OC/OES/DFOI/ 

1     U*V  VJ  Vw//  VJ  1 —  VJ/  1— '  1     V-/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   VJLIIL    I  VJ  VJ L—  VJ  U     1  \J J 

MERCK  &  CO.,  INC. 

2012-6055 

2012-7818 

10/30/2012 

1  \Jl  \J\Jl  L—\J\S— 

11/28/2012 

FDA/OC/OES/DFOI/ 

1    U*V  Vw/  Vw//  Vw/  1 —  VJ/  U  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   VJLIIL    I  VJ  VJ L_ VJ  U     1  \J  1 

MERCK  &  CO.,  INC. 

2012-5914 

2012-7819 

10/30/2012 
11/28/2012 

FDA/OC/OES/DFOI/ 

1    U*V  VJ  VJ/  VJ  1 —  VJ/  U  1    VJ  1/ 

Joan  Stitt  (UG2CD-16} 

v/V/Clll    VJLIIL    I  VJ  VJ  L_  VJ  U     1  \J  j 

MERCK  &  CO.,  INC. 

2012-5887 

L_ V/  1  i—    JUU  / 

2012-7820 

10/30/2012 

1  \JI  \J\JI  L—\J\S— 

11/28/2012 

FDA/OC/OES/DFOI/ 

1    U  / V/  VJ  VJ/  VJ  1 —  VJ/  U  1    \J  1/ 

Joan  Stitt  (UG2CD-16} 

WV/CLI  1   VJLIIL   \\J\Jt_\JU     1  \J  1 

MERCK  &  CO.,  INC. 

2012-5683 

L.U  1  l_  JUUU 

2012-7821 

10/30/2012 
11/28/2012 

FDA/OC/OES/DFOI/ 

1    u  / V/  VJ  VJ/  VJ  1 —  VJ/  U  1    VJ  1/ 

Joan  Stitt  (UG2CD-16} 

WV/CLI  1   VJLIIL    I  VJ  VJ  L—  VJ  U     1  "J  J 

MERCK  &  CO.,  INC. 

2012-6309 

L—\J  1  £-  UUUU 

2012-7822 

10/30/2012 
11/28/2012 

FDA/OC/OES/DFOI/ 

1    u  / V/  VJ  VJ/  VJ  1 —  VJ/  U  1    VJ  1/ 

Joan  Stitt  (UG2CD-16} 

WV/CLI  1   VJLIIL    I  VJ  VJ L_ VJ  U     1  V/  1 

MERCK  &  CO.,  INC. 

2012-6250 

L.U   1  l_  UL.UU 

2012-7823 

10/30/2012 
11/28/2012 

FDA/OC/OES/DFOI/ 

1    u  / V/  VJ  VJ/  VJ  1 —  VJ/  U  1    VJ  1/ 

Joan  Stitt  (UG2CD-16} 

UUQI  1   VJLIIL    I  VJ  VJ L_ VJ  U     1  V/l 

MERCK  &  CO.,  INC. 

2012-6225 

£_  V/  1  L       V/  L_  £_  J 

2012-7824 

10/31/2012 

i  \ji  vj  i  / 1 —  v/  i  l — 

11/29/2012 

FDA/OF/CFSAN/OCD/EOS/ 

JEFFREY  BARRACK 
Jeffrey  Barrack 

MONSTER  ENERGY  DRINKS  -  AERS;  DEATH  REPORTS 
(11/07  TO  PRESENT) 

2012-7825 

10/31/2012 

ORA/ 

M42-31 42497-7  -  TEST  RESULTS 

11/29/2012 

ORA/ 

Triunfo-Mex,  Inc. 

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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

2012-7826 

10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

OH/IITLJ    AMR  m  r"ni  1 1 — t  a  /      /~»  /~\  r—\  r—\  \  A  /  IT |  i  i —  r^>  a    nr  nmUlM      U  AMI 

SMITH  AND  NEPHEW  -  CORR  WITH  FDA  RE  BIRMINGHAM 

1 1/29/2012 

FDA/OO/OES/DDM/ 

Doe  J 

HIP  RESURFACING  DEVICE 

2012-7827 

10/31/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

i_i\/i  AKinip  in OTAMn  a  n r^v  i  i /*■> a  a i —  s~\ n lj  a -ri_i i z"1      /~v     /~»/-\ n n 

HYLAND  S  INC,  STANDARD  HOMEOPHATHIC  CO  -  CORR 

1 1/29/2012 

DO/LOS-CB/ 

Law  Offices  of  Ronald  A.  Marron 

WITH  FDA  RE  CALMS  FORTE,  TEETHING  TABLETS, 

FDA/OMPT/CDER/ORP/DIDP/ 

MIGRAINE  HEADACHE  RELIEF,  ETC 

FDA/OMPT/CDER/ORP/DIDP/ 

1    i  '  / V/  Vw/ 1 V  1 1      1  /  \_/  1— •*  1  1  1/  V— III    /  L-/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FUA/UMP  1  /CUEK/UKP/UIUP/ 

FDA/OGROP/ORA/CE-FO/PHI- 

DO/PHI-CB/ 

2012-7828 

10/31/2012 

1  W/  >w>   1  /  £—  V/   1  L_ 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

K965001 

1  \\J\J\J\J\J  1 

1 1/29/2012 

FDA/OO/OES/DFOI/ 

1    L//V/  V_/  Vw//  V_/l — O/  1— /  1    V/  1/ 

Rhpffipld  Dphnrah 

w  1  J  C  1  1  1  C IU  .    1  '  C  k/ VJ  1  dl  1 

2012-7829 

10/31/2012 

FDA/OC/OES/DFOI/ 

Megan  Pickel 

CFSAN  FOIA  REQUESTS  (09/27/2012  -  10/26/2012) 

11/29/2012 

BEVERIDGE  &  DIAMOND 

2012-7830 

10/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

FDA  INVESTIGATOR  TRAINING  COURSE  MATERIAL;  DRUG 

11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

GMP  Training  Materials 

GMP  TRAINING  COURSE  MATERIAL  (01/01/2011  -  10/26/2012) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ORM/ 

Vw /  1  1 1  \i  Vw/  1  1 1 V 1  / 

ORA/ORM/ 

ORA/ 

ORA/ 

2012-7831 

10/31/2012 

1  V//  V/  1  /  L—\J   1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  l_/  1  L/  1  / 

ANDA  091347  -  EFFECTIVE  APPROVAL  LTR 

/  VI  *J  1  /  /  \   Uv  1  U    i  /          1  1     1     1  V/  1  1  V  1— —  1  \  \     \     \  I  Vw/  v  1  \  1—   ^  1   1  I 

1 1/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

IPD  ANALYTICS  LLC 

II    l_/  r\l  MnL  1    1  IV_/v_J   1  1  V/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Of~H  O  7001 

10/31/2012 

FUA/OMP  1  /CUKn/OCtK/DFUl/ 

Kelly  Cycon 

Y—  |  1  1  II    AD  DD/"\r~\l  1  r^~TO               AMn  UTI  \/  HI  APMAPTir  l/ITO 

GhLLULAK  rHUUUO  1  o  HIV  AND  H  1  LV  UlAbNUo  MO  KM  o  - 

03/11/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

Zeptometrix  (Formerly  Cellular 

APPROVAL  RECORDS  f01/01/1985  -  12/31/1 989^ 

l  \  \     1     1  l  Vw/  V  1  V  L_   1  1 1_ \J  Vw/  1  1 1  /  V/    lv  1  /  v  1  /    1  JUv          1  L-/  O  1  /    1  \J\J\J  I 

ALFB/ 

Products) 

2012-7833 

1 —  V/   1  £ —     /   1*/  v_J 

10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

K1 1 1593 

11/29/2012 

Seawon  Meditech  Co.,  Ltd. 

2012-7834 

10/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Gary  Syring 

K082474 

11/29/2012 

Quality  &  Regulatory  Associates, 

Page  73  of  895 


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Reed  Date  / 
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Signature/  Requester 

Subject 

LLC 

2012-7835 

10/31/2012 
11/29/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Robert  MacArthur 

Alternative  Research  Services,  Inc. 

MONSTER  BEVERAGE  CORP  -  REPORTS, 

2012-7836 

10/31/2012 
11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Li  a  Obata  Dowd 
Dowd  &  Dowd,  PC 

BOEHRINGER  INGELHEIM  PHARM,  INC;  BOEHRINGER 
INGELHEIM  CORP;  BOEHRINGER  INGELHEIM  USA,  ETC  - 
PRADAXA  RECS,  APPLICATIONS,  AERS,  ETC 

2012-7837 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Angelia  Slayton 

NDA  201803 

11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-7838 

10/31/2012 
11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Joan  Stitt(UG2CD-16) 
MERCK  &  CO.,  INC. 

DIRECT  REPORTS,  MEDWATCH  REPORTS,  SOURCE 
DOCUMENTS  -ISR  8404106-1 

2012-7839 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Joan  Stitt(UG2CD-16) 

ISR  NUMBERS  6673059-9,  6691992-9,  6709086-2  ETC 

11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MERCK  &  CO.,  INC. 

2012-7840 

10/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Joan  Stitt(UG2CD-16) 

ISR  7267891-0,  8058598-0,  8099049-X  ETC 

11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MERCK  &  CO.,  INC. 

OfH  O  ~7QA  1 

rUA/UMr  I  /L/Utri/UrSr/UIUrV 

rUr  -  Abrib 

11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HARPER  #34654,  JOHNATHAN 
SETH 

OfH  O  "7QA  O 

1  U/ol/^UI  *i 

11/29/2012 

rUA/UMr  1  /OUnn/UUtn/UrUI/ 

a  i  aim  miop\m 
ALAIIn  NIIjjUN 

ALN  IMPLANTS  CHIRURGICAUX 

WILLIAM  L>UUI\  tUHUrt  Arb  -  L>UUI\  OtLtO  1  VeInA  OAVA 

FILTER  AND  GUNTHER  TULIP  VENA  CAVA  FILTER 
RETRIEVAL  SET  K073374 

2012-7843 

10/31/2012 
11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CAROL  DRURY 

ENDOMETRIOSIS  ASSOCIATION 

NUMBER  OF  THERAPIES  APPROVED  BY  THE  FDA  FOR  THE 
TREATMENT  OF  ENDOMETRIOSIS 

Page  74  of  895 


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Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

2012-7844 

10/31/2012 
11/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

OC/COS/OES/ 
OC/COS/OES/ 
OM/OMP/DODM/ 

LEIGH  A  SANDERS 

CENTER  FOR  RESPONSIBLE 
SCIENCE 

DKTS  2007P-0109,  2007P-0457;  DRAFT  GUIDANCE  TO 
INDUSTRY  REGARDING  NON-ANIMAL  TESTS  FOR  DRUG 
DEVELOPMENT  PROGRAMS,  ETC 

2012-7845 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

AMERICAN  MEDICAL  SYSTEMS  -  AMS  ELEVATE  APICAL 
AND  POSTERIOR  PROLAPSE  REPAIR  SYS  WITH  INTERPRO 
LITE,  INTEXEN  LP  K082730  (CERTIFIED);  SUBSTANTIAL 
EQUIVALENCE  LTR  1 1/26/08  (CERTIFIED) 

2012-7846 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ft  A    ft  A  I-  1     1  f\  f\  A            A  1    "T" — 7 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

A  ft  A  I-        1  /"\  A  ft.  1    ft  A  I-  1— v  1  /"\  «  |       /"\  \  /  f~~\  —r-  f—  m    m                 A  ft  A          I-  |     f~  \  /  A  "T~  I~    \  A  /  1  ~T~  1  1 

AMERICAN  MEDICAL  SYSTEMS  -  AMS  ELEVATE  WITH 
INTEPRO  LITE  PROLAPSE  REPAIR  SYS,  AMS  ELEVATE 
WITH  INTEXEN  LP  PROLAPSE  REPAIR  SYS  K080185 
(CERTIFIED);  SUBSTANTIAL  EQUIVALENCE  LTR  4/10/08 
(CERTIFIED) 

2012-7847 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

AMEICAN  MEDICAL  SYSTEMS  -  AMS  APOGEE  VAULT 
SUSPENSION  SYS  K040537  (CERTIFIED);  SUBSTANTIAL 
EQUIVALENCE  LTR  4/.22/04  (CERTIFIED) 

2012-7848 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

AMERICAN  MEDICAL  SYSTEMS  -  APOGEE  AND  PERIGEE 
SYSTEMS  WITH  INTEPRO  LITE  AND  INTEXEN  LP  PELVIC 
FLOOR  REPAIR  SYS  K082387  (CERTIFIED);  SUBSTANTIAL 
EQUIVALENCE  LTR  12/4/08  (CERTIFIED) 

2012-7849 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

BARD  UROLOGICAL  DIVISION  -  AVAULTA  SOLO  SUPPORT 
SYS,  AVAULTA  PLUE  BIOSYNTHETIC  SUPPORT  SYS 
K063712  (CERTIFIED);  SUBSTANTIAL  EQUIVALENCE  LTR 
3/27/07  (CERTIFIED) 

2012-7850 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

BOSTON  SCIENTIFIC  CORP  -  PINNACLE  PELVIC  FLOOR 
REPAIR  KIT  K071957  (CERTIFIED);  SUBSTANTIAL 
EQUIVALENCE  LTR  1/13/09  (CERTIFIED) 

2012-7851 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

BARD  UROLOGICAL  DIVISION  -  AVAULTA  SOLO  SUPPORT 
SYS,  AVAULTA  PLUS  BIOSYNTHETIC  SUPPORT  SYS 
K082571  (CERTIFIED);  SUBSTANTIAL  EQUIVALENCE  LTR 
9/30/08  (CERTIFIED) 

2012-7852 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

BOSTON  SCIENTIFIC  CORP  -  TBD  SURGICAL  MESH  DVC 
K081048  (CERTIFIED);  SUBSTANTIAL  EQUIVALENCE  LTR 
8/22/08  (CERTIFIED) 

2012-7853 

10/31/2012 
11/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

AMERICAN  MEDICAL  SYSTEMS  -  APOGEE  AND  PERIGEE 
SYTEMS  WITH  PC  COATED  INTEPRO  LITE  K081710 
(CERTIFIED);  SUBSTANTIAL  EQUIVALENCE  LTR  10/15/08 
(CERTIFIED) 

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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-7854 

10/31/2012 
11/29/2012 

OC/OM/OMP/DDIW 

THOMAS  D.  FITZGERALD 

FSI  RESEARCH  &  SERVICES, 
INC. 

DKT  FDA-2012-P-0632,  FDA-2012-P-1018 

2012-7855 

11/01/2012 
11/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Sevrina  Ciucci 
Sevrina  Ciucci 

K061268 

2012-7856 

11/01/2012 

ORA/ 

CONSUMER  COMPLAINT  RECS 

1 1/30/2012 

ORA/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Doe  J 

2012-7857 

11/01/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Shane  Baker 

MASCOMA  CORP  -  RECOMBINANT  YEAST  PRODUCTS 

11/30/2012 

ALFB/ 
CVM/OCD/ 

Joint  Investments  LLC 

2012-7858 

1 1/01/2012 

1     1  /  \J    1  /  t—\J    1  L— 

11/30/2012 

FDA/OC/OES/DFOI/ 

Todd  Wallack 

1  V/V/VJ    V  V  Cll  1  Cfw-rV 

BOSTON  GLOBE 

NEW  ENGLAND  COMPOUNDING  CENTER  AMERIDOSE  - 

1  M  1      V  V    1  1  V  V_/  1  /  VI  >J  1  /    V/  Vw/  1  V 1  1     Vw/  V_/  1  *J  L/  1  1  N  V_/    V/  l_  1  VI  1  1— —  1  I  .   I  \  1  V 1  1  1  1 1  l_/  V_/  V/  1— — 

FOIA  REQUESTS,  RESPONSES  (01/01/2004  -  10/30/2012) 

2012-7859 

1 1/01/2012 
11/30/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

1  1 — '  /  v  \w/  \_H  [  1 W  1    /  Vw/  1  1/  V/  V— '  l_    1    Vw//  1    L_j V 

DO/FLA-CB/ 

Mirhapl  P  Krpn^avanp 
Krensavage  Asset  Management 

RTI  BIOLOGICS  ALACHUA  FL  -  WARNING  LETTER  RECS 

1  l  1  1    1  '  1  V/  l_  Vw /  V»/  1  Vw/  Vw/  .    /  V I—/ \  V/  1   1  Vw//  \  j    1    1            V  V  1  V 1  U  N  1 1  v  V/    1  1       1     1  1  1  1    1  I  L.V/V/ 

2012-7860 

11/01/2012 
11/30/2012 

FDA/OC/OES/DFOI/ 

Jared  MacCleary 
CROWELL  &  MORING 

FOIA  LOGS  FOR  CVM  (04/01/2012  -  10/31/2012) 

2012-7861 

11/01/2012 
11/30/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

L/  V  /   /  V  I  E       V/  I  ' 

Jose  H.  Lebron,  Stat  Rx  QA 
Mananpr 

Stat  Rx 

STAT  RX  -  484,  483,  EIR  (01/01/2006  -  1 2/31/201 1 ) 

2012-7862 

1 1/01/2012 
11/30/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

1    L/  1  \l  Vw/  \*A  1  1  Vw/  1    /  Vw/  1  IV  V/  1    / \    1    Vw//  ^V/VJ 

DO/LOS-CB/ 

LEERINK  SWANN  LLC 

AUTOGENOMICS  VISTA  CA  -  EIR  (09/01/2009  -  09/22/2009} 

/  \  Vw/  i  Vw/  Vw/  I— _  i  *i  Vw/ 1  v  1 1  Vw/  Vw/  j    vi  Vw/  i  '  v ,  v/ 1  \       \  1 1  i  i  \j  \ji  \j  i  /  C—  \J  \J  \j       \j  \ji  w_  £_/ t_  v/  \/  *_/  j 

2012-7863 

£-  W  1  t_    /  VJ  vj  O 

1 1/01/2012 

1    \  l\J  \  1  C\J  1  c 

11/30/2012 

ORA/ 
ORA/ 

Anrlrpw  Kphn 

I  \  \  \  KJ  1  CVv    1  VCll  II  1 

UNITE  HERE 

ST  JLJDE  MEDICAL  SYLMAR  CA  -  483  (09/01/2012  - 

v_/  i   vj  v_/ 1_/ 1      i vi  i  \—f  i  v/r\L ,  v./  i  i  ivini  \ ,  v/ /  v     t^uu  i  v_/ u  i  /  c—\j  i  l_ 

10/30/2012) 

2012-7864 

11/01/2012 
11/30/2012 

CVM/OCD/ 

Rob  Varese 

SHOTWELL  &  CARR,  INC. 

TYPE  B  AND  TYPE  C  MEDICATED  FEEDS  - 
MICROBIOLOGICAL  ASSAY  METHOD 

2012-7865 

11/01/2012 
1 1/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISA  BALTZ 
BUTLER  SNOW  ET  AL 

C  R  BARD  INC,  COVINGTON,  GA  -  AVAULTA  SOLO 
SUPPORT  SYS  &  AVAULTA  PLUS  BIOSYNTHETIC  SUPPORT 
SYS  K083839  (CERTIFIED) 

2012-7866 

11/01/2012 
11/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ETAL 

AMERICAN  MEDICAL  SYSTEM,  MINNETONKA,  MN  -  AMS 
ELEVATE  PC  ANTERIOR  &  APICAL  PROLAPSE  REPAIR  SYS 
WITH  INTEPRO  LITE  K1 1 1 1 18  (CERTIFIED) 

2012-7867 

11/01/2012 
11/30/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

CALDERA  MEDICAL  INC,  AGOURA  HILLS,  CA  -  ASCEND 
BLUE  MESH  AC  &  PC  K101462  (CERTIFIED) 

2012-7868 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

COLOPLAST  A/S,  HUMLEBAEK,  DENMARK  -  EXAIR 

Page  76  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

11/30/2012 

BUTLER  SNOW  ET  AL 

ANTERIOR  &  PROLAPSE  REPAIR  SYS  K1 12386  (CERTIFIED) 

2012-7869 

1  1/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

AMERICAN  MEDICAL  SYSTEMS  INC,  MINNETONKA,  MN  - 

1 1/30/2012 

BUTLER  SNOW  ET  AL 

ELEVATE  PC  ANTERIOR  &  APICAL  PROLAPSE  REPAIR  SYS 
WITH  INTEPRO  LITE  &  ELEVATE  PC  APICAL  &  POSTERIOR 
PROLAPSE  REPAIR  SYS  WITH  INTEPRO  LITE  K1 12842 
(CERTIFIED) 

2012-7870 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISA  BALTZ 

MPATHY  MEDICAL  DEVICES  LTD,  RAYNHAM,  MA  - 

1 1/30/2012 

BUTLER  SNOW  ET  AL 

RESTORELLE  POLYPROPYLENE  MESH  K092207 
(CERTIFIED) 

2012-7871 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISA  BALTZ 

AMERICAN  MEDICAL  SYSTEMS,  MINNETONKA,  MN  - 

11/30/2012 

BUTLER  SNOW  ET  AL 

ELEVATE  ANTERIOR  &  APICAL  PROLAPSE  REPAIR  SYS 
WITH  INEPRO  LITE  K082677  (CERTIFIED1) 

VVIIII    IINI  1     1  1  Vw/    1  III        1  \v/Ul.IJ  /    /     1  Vw/  1  [llll     II  1  '  1 

2012-7872 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

CALDERA  MEDICAL  INC,  AGOURA  HILLS,  CA  -  ASCEND 

11/30/2012 

BUTLER  SNOW  ET  AL 

SURGICAL  MESH  K083722  (CERTIFIED) 

2012-7873 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

AMERICAN  MEDICAL  SYSTEMS,  MINNETONKA,  MN  - 

11/30/2012 

BUTLER  SNOW  ET  AL 

ELEVATE  PROLAPSE  REPAIR  SYSTEM  WITH  PC  COATED 
INTEPRO  LITE  K090713  (CERTIFIED) 

2012-7874 

1 1/01/2012 

■ —  r-\  a  1  f\  h  a  r-\-r  //-v  nni  1  //"\  /~<  I —  i— i  ;r-\  i — /~\  i  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

II  III —  1    1    1  (™i  O  A    n«i  T — 7 

M  MELLISSA  BALTZ 

A  l  HI —  n  1  /~i  AM    k  11 —  |~~\  1  /~\  A  I  0\/0~T"l —  R  A  O    IK  1  /"V      Ik  >|MM  I  1-  /*"\  K  11/  A       It  A  K  1 

AMERICAN  MEDICAL  SYSTEMS  INC,  MINNETONKA,  MN  - 

1 1/30/2012 

BUTLER  SNOW  ET  AL 

ELEVATE  ANTERIOR  &  APICAL  PROLAPSE  REPAIR  SYS, 
APICAL  &  POSTERIOR  PROLAPSE  REPAIR  SYS,  APICAL  & 
POSTERIOR  PROLAPSE  REPAIR  SYS  WITH  INTEXEN 
K121612  (CERTIFIED) 

2012-7875 

11/01/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

COLOPLAST  A/S,  HUMMLEBAEK,  DENMARK  -  EXAIR 

11/30/2012 

BUTLER  SNOW  ET  AL 

ANTERIOR  &  EXAIR  POSTERIOR  PROLAPSE  REPAIR  SYS 
K083499  (CERTIFIED) 

2012-7876 

1 1/01/2012 

1  1  /  \J  1  /  t—\J  1  t_ 

FDA/OGROP/ORA/SE-FO/SJN- 

AMY  WADE 

/ilvl   1      V  V  I  \  L/  l__ 

CARDINAL  HEALTH  PR  41 0  INC  HUMACAO  PR  -  EIR  6/07- 

v/ni  i  \—i  1 1  inL  i  1 1  ni  iii  i   1  i  t  i  u  iim  \j .  i  i  \j  i  v  irw/nv/j  i   i  i     i  1 1  i  \ji  \j  i 

11/30/2012 

DO/SJN-CB/ 

NOVARTIS  ANIMAL  HEALTH 

16/04 

2012-7877 

11/01/2012 
11/30/2012 

FDA/OF/CFSAN/OCD/EOS/ 

DANIEL  R  LUCKY 

LUCKY  CONSULTANTS  LLC 

FCN  1162 

2012-7878 

1 1/01/2012 

1  1  /  \J  1  /  t—\J  1  i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

SHERRY  L  ROLLO 

\J  1       1  1— —  1       l  1       l      1           l_  ■         1       l  Vw/  l_  1_  Vw/ 

SANDOZ  -  OLMESARTAN  MEDOXOMIL  NDA  90-237  APRVL 

Vw/  /  VI  M  l_/  Vw/  L            \  '  L_  1  V 1  1  Vw/ 1  \  1  1  1  1  \  IN    1 V 1  1— —  L*S  \  '  /  \W  1  V  1  1  l_    1  M  L/  /  V     \J  \J    C—  \j  1     1  \  1     1  I  V  L» 

11/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HUSCH  BLACKWELL  LLP 

LTR  9/1 6/09 

2012-7879 

1 1/01/2012 

1  1  /  \J  1  /  t—\J  1  i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

SHERRY  L  ROLLO 

\J  1       1  1— —  1       l  1       l       1            1          ■         1       l  Vw/  1_  1_  Vw/ 

MYLAN  PHARMS  INC  -  OLMESARTAN  MEDOXOMIL  APRVL 

1 V  1   1   1  /  \  111     II I  \  1  1 1  V 1  Vw^    1  1  >l  V/        w  L_  1 V 1  1— —  Vw/ 1  \  III  I  \  1  VI    1  v  1  1— —  Lw/  Vw/  /  \  Vw/  1  V  1  1  l_  /  \  1     1  I  V  L- 

1 1/30/2012 

i  if  uv/ 1 —  v/  i  l — 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HUSCH  BLACKWELL  LLP 

10/3/08,  5/15/12 

2012-7880 

11/01/2012 

FDA/OF/CFSAN/OCD/EOS/ 

MADHU  SONI 

CAFFEINE  -  CAERS  1/05  TO  3/12 

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Control  # 


Reed  Date  / 
Due  Date 


Action  Office 


Signature/  Requester 


Subject 


11/30/2012 


SON  I  &  ASSOCIATES  INC 


2012-7881 


2012-7882 


11/01/2012 
11/30/2012 
11/01/2012 
11/30/2012 


FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 


CARSTON  C.  JOHANNSEN 
GOULD  LAW  OFFICES  CHTD  LLC 
CARSTON  C.  JOHANNSEN 
GOULD  LAW  OFFICES  CHTD  LLC 


OPTIMAL  PAIN  CONTROL  CREAM  -  AER  SINCE  2010 


DICLOFENAC  -  AER  SINCE  2009 


2012-7883 


11/01/2012 
11/30/2012 


FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

ORA/OCI/ 

ORA/OCI/ 


CARSTON  C.  JOHANNSEN 
GOULD  LAW  OFFICES  CHTD  LLC 


FRANKLIN  PHARMACY,  ALABAMA  &  SHEFFIELD  PHAMRCY 
&  HOMECARE,  FRANKLIN  COUNTY,  ALABAMA  CONNECTION 
WITH  DANIEL  MITCHELL  MD,  HAWNEE  MISSION  MEDICAL 
CTR  FOR  PAIN  MEDICINE,  SHAWNEE  MISSION,  KS  -  RECS 
2009  TO  PRESENT 


2012-7884 

11/01/2012 
11/30/2012 

CVM/OCD/ 

KRISTI  O.  SMEDLEY,  Ph.D. 
Center  for  Regulatory  Services,  Inc. 

PHYTASE  -  RVW 

2012-7885 

11/01/2012 
11/30/2012 

CVM/OCD/ 

KRISTI  O.  SMEDLEY,  Ph.D. 
Center  for  Regulatory  Services,  Inc. 

GENENCOR  -  RVW 

2012-7886 

11/01/2012 
11/30/2012 

FDA/OC/OES/DFOI/ 

CHASTINE  12B2563,  JAMES 

FDA  ORGANIZATIONAL  CHART 

2012-7887 

11/01/2012 

ORA/ 

KATIE  THOMAS 

ST  JUDE  MEDICAL,  SYLMAR,  CA  -  483  1 0/1 7/1 2 

11/30/2012 

ORA/ 

NEW  YORK  TIMES 

2012-7888 


2012-7889 


2012-7890 


11/01/2012 
11/30/2012 


11/01/2012 
11/30/2012 


11/01/2012 
11/30/2012 


FDA/OF/CFSAN/OCD/EOS/ 

ORA/ 

ORA/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/  

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 


PATTI  WALLER 
MARLER  CLARK  ATTYS 


SALMONELLA  ENTERIDITIS  OUTBREAK  3/00  TO  4/00 


MARSHA  JAFARY 
RECKITT  BENCKISER  INC 


KRISTEN  FASO 

LAW  OFFICES  OF  DAVID  W 
HOLUB 


FLURBIPROFEN  -  AER  1/08  TO  10/20/12 


NEW  ENGLAND  COMPOUNDING  PHARMACY  -  RECALL; 
LICENSING  MENINGITIS  PRODUCING  STERIOD 
MEDICATIONS 


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Pnntrnl  if 

nfciOU  L/dLc  / 

MOLIUll  wlllLrC 

oiyiidLure/  rietjUebLci 

Ci  i  il™iiQ/^t 

ouujeoi 

Due  Date 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

oc/occ/ 

V_/\_// 

ORA/ 

ORA/ 

OC/OL/ 

2012-7891 

1 1/01/2012 

1    1  /  \J  1  /  L—\J  1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  V— /  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

HOSPIRA  GUJARAT  INDIA- DR  REDDYS  INDIA' SUN 

1   1  \-S  *S  1     II  1 / \ .        i  Vw-'  KJ 1  \  1  1 1  \  1  j    1  1  N  I—'  1  / \  j    IS  1  1    1  1 1  1— /  IS   1  Vw/  .    IIM  IS  1  /  V  ,    \S  \s  1  *J 

1 1/30/2012 

1    1  /  \J\JI  C-\J  1 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  »  I  \i  V_/ 1  v  1 1     1  /  \J  IS  1  1  1/  W  III    /  !_/  1 1  '  1  / 

GIJRAL  MARILYN 

PHARMA,  INDIA  -  483,  WARNING  LTRS,  EIR  1/07  TO  8/12 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  Lh'  1  1  1/  \w/  III    /  IS  1  L*/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  \  '  Lh'  1  1  1/  \s  III    /  1 — '  1  L-/  1  / 

C\J  I  C    1  (JZJ i— 

1 1/01  /?01? 

1  \I\J  \l  C\J  \  (— 

FDA/OF/r.F^AN/onn/Fnc;/ 

1    is  r\l       1  /  0 1   0/\  1  \l/  V_/\_/ 1—//  1  \_y  o/ 

MARII  YNN  WHITNFY 

I  virA  n  1 1_  T  I  >i  I  >J  v  v  I  1 1  I  I  n  i_  i 

MON9TFR  FNFRfiY  -  HAFR^-  MON^TFR  FNFRRY  PRDD^ 

i v i v  / 1 no  i  i  i  i  i  i n i  i  i \j  i       unt no ,  1 VI V_/l MO  1  1  1  I  1  1  N  1  1  1  \J  I    I    1  i V_/ Is o 

1 1/30/2012 

COVINGTON  &  BURLING  LLP 

2004  TO  PRESENT 

2012-7893 

11/01/2012 

FDA/OF/CFSAN/OCD/EOS/ 

MEG  P.  DADAY 

CRONOBACTER  SAKAZAKII  -  INVESTIGATION  RECS, 

12/04/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

SEDGWICK  LLP 

TTPTIMP    HATA      1    AD   Ol  II —  1  TO     |  T/^1   A  IA  H    T nnrOTMT 

TESTING  DATA,  LAB  SHEETS,  ETC  1/1 1  TO  PRESENT 

DO/O  HI -OB/ 

FDA/OGROP/ORA/SW-FO/KAN- 

DO/KAN-CB/ 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

FDA/OC/OES/DFOI/ 

OC\-\  O  7QQ/1 
c\)\  dr /C)y4 

1  i  /n  1  /on  1  o 

rUA/Ur/UroAN/UUU/tUo/ 

1  C\C  1  ADCCM 

Ltlr  LArlobN 

OnAMrlUN  rt  I  rUUUo  -  AOAINA  (jriAooLANUo  UUu 

11/30/2012 

FDA/OGROP/ORA/ORO/DIOP/ 

CBC  NEWS 

FOOD-  STRAUSS  HERBS  -  VITAMINS  MOISTURIZING 

1    WW  Is  .  \j  1  [  1 1  \  \S  v  '  v  }  I  ||  I  I  IS  Vw/        V  1  1  i\  \  V  1  1 1  M  v  }  .    I  V  1  \-/  1  O  1  U  I  1 1 1—  1 1  N  \s 

HERBAL  BODY  WASH,  HERBAL  LOTION,  ETC;  BUNGE 

FDA/OGROP/ORA/CE-FO/CIN- 

CANADA  NIPAWIN  -  CANOLA  MEAL,  ETC  IMPORT 

DO/CIN-CB/ 

REFUSALS 

FDA/OGROP/ORA/CE-FO/DET- 

DO/DET-CB/ 

FDA/OGROP/ORA/CE-FO/MIN- 

DO/MIN-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

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Control  # 

Reed  Date  / 

UUc  LJdLc 

Action  Office 

Signature/  Requester 

Subject 

DO/NYK-DCB/ 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OGROP/ORA/SE-FO/SJN- 
DO/SJN-CB/ 

2012-7895 

1 1/01/2012 
11/30/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  Vw/  1    \-S  l\\  Ml  Vw/  Vw/  I—/ 1  l__  Vw/  V-J/ 

SCOTT W  ROONEY 

\-}\—l\—/  II      V  V  .    1  1  Vw/V-'l  M  1   1 

NEMES  ROONEY  ET  AL 

FIVE  HOUR  ENERGY  -  CAERS  INVESTIGATION  RECS 

1     1  V  1        II  Vw/  K-f  11    1  INI  1  ly^A  1          V/ 1  \  1  1  I  w  ,    UN  V  1  \J  1  1  Vw^  / V  1  1  V_/l  N    1  l 1  \J  vJ 

2012-7896 

i—  \J    1   C—      1  \J\J\J 

1 1/02/2012 

1     1  /  \J  L—l  L—\J\L— 

12/03/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CARLA  R  SCARMAZZI 

V/ 1  \  1  1 1  1  \  1  1  v  '  V_/ 1  \  1  1 1 V 1 1  \£—£—  \ 

King  &  Spalding  LLP 

2012-6462  2012-6463  2012-6464  2012-64(55 

C—  \J  1  C—   UtUL,  C—  \J  1  C—   UtUvJ,  C—\J  1  C—    UTUT^^  £— V/  1  L_   V/  t  UU 

2012-7897 

L—  \_/    1  L—      1    \J\J  I 

1 1/02/2012 

1     1  /  \J  L—l  L—\J\L— 

12/03/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  V/  1    v//\  1  N/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

CRAIG  ROUSH 

Vw/  1       1 1      \  1   \—A        1       I  Vw/   U  Vw/  |  | 

ROCKLINE  INDUSTRIES 

LIST  OF  ACTIVE  COSMETIC  ESTABLISHMENTS 

1  1  \w/  1     V-/  1      /  V  Vw/  1  1  V  1— —    Vw/  Vw/  O  1 V 1  1— —  1  1  Vw/    l__        1  /  V 1  '  1  1  V/  1   1  1  v  1  1  1  V  1  u 

2012-7898 

11/02/2012 
12/03/2012 

FDA/00/0FBA/0AGS/ 
FDA/OC/OES/DFOI/ 

JEFF  STACHEWICZ 
FOIA  GROUP  INC 

HHSF223200830014I  -  CONTRACT,  MODIFICATION, 
AMENDMENTS  ETC 

/  VI V  1  1  1  M  I— '  1 V 1  1  1  N  1  \J  ,    1       1  \_/ 

OA-io  7onn 

201<i-7899 

^  -i  /ao  /oa  ^  o 

1 1  /Old./ 2.0 1  2 
12/03/2012 

rUA/UuKUr/UKA/fat-rO/rLA- 
DO/FLA-CB/ 

UANItL  MAOWILLIAMb 

WILSON  ELSER  MOSKOWITZ 
EDELMAN  &  DICKER  LLP 

rKANOKb  UOIVIrUUNlJlNlj  rHAKMAOY,  OOALA,  rL - 
BACTERIAL  AND/OR  MICROORGANISM  GROWTH  TESTING 
RECS 

2012-7900 

1 1/02/2012 

1     1  /  \J  L—l  L—\JiL— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    I—*  1  \l  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  Vw/  III    /  L-/  1  1— /  1  / 

FI71P  1  Rurnhpr 

1_  1 1—  \  \j    1       1  '  LJ  1  \A  1  1  V^  1 

ORENCIA  -  AERS 

Vw/  1   l  1  1  4  \—S  1 1  \        1  \  1  1  I 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Burgher,  Elzie  L 

2012-7901 

11/02/2012 
12/03/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Adam  Sanders 

Adam  Sanders,  attorney  for  Insight 
Pharm 

K941765,  K936013,  K934830  ETC 

2012-7902 

11/02/2012 
12/03/2012 

FDA/OF/CFSAN/OCD/EOS/ 
0C/C0S/0ES/ 

MARK  MCAFEE 

RAW  MILK  INSTITUTE.ORG 

DR  GREGORY  MILLER  PHD,  CALIFORNIA  DAIRY  RESEARCH 
FOUNDATION  -  MILK  RELATED  RESEARCH  ACTIVITIES 
CORR 

0C/C0S/0ES/ 

2012-7903 

1 1/02/2012 

1    1  /  \J  L—l  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1     l—*  1  \l  Vw/  1  v  1  1       1  /  V/  lw/  1  1    1/  Vw/  III     /  L/  1  lw/  1  / 

Dpnni^  W  Rai^rh 

L/Ul  1 1  1 1 0    VI  ■    1  Id  1  OVjl  1 

FINASTERIDE  DUTASTERIDE  -  AERS 

i   1 1  inw  i  i— _ i  1 1  Lw/ 1  ,  i — *  \j  i  v  \ i  i  i  1 1  iw/ 1_      /  \ i  i  i u 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  NEW  MEXICO 
SCHOOL  OF  MEDICINE 

2012-7904 

1 1/02/2012 

1     1  /  \J  L—l  L —  \J    1  £ — 

FDA/OMPT/CDER/ORP/DIDP/ 

DGnnis  W.  Raisch 

BRENTUXIMAB  -  AERS 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  NEW  MEXICO 

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Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

2012-7905 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Cynthia  McHale 

DERMAMEDICS,  LLC  -  INVESTIGATION,  INSPECTIONS  OF 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Law  Firm  of  McAfee  &  Taft 

LABELING,  ADVERTISING,  PRODUCT  INFORMATION  ETC 

(01/02/2012  -  11/01/2012) 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \J  \—J  1  1  1/  \-s  III    /  I — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

ORA/OCI/ 

2012-7906 

1 1/02/2012 

1     1  /  \J  L—l  L—\J\L— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       IS  1    \l    \w/  1  V  1  1          1    /  \m/  L- /  1     11      1/    V_/  \w /  l_  |     1/    1  /  |       Vw/  J/ 

1  avpnia  Ford 

1 —  CI  V      1  1  1  CI    1    Ul  u 

K000442 

12/03/2012 

Cardinal  Health  200,  LLC 

2012-7907 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Kelly  Joohnson 

HOSPIRA,  SAN  CRISTOBAL,  DOMINICAN  REPUBLIC  -  EIR 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V- /  L/  1  1  1/  V_/  III    /  I — /  1  1  /  1  / 

Fahvan^kp  Wp^tra  Hart  & 

(6/15/2009  -  12/15/2009) 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  V- /  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

Thomson,  P.A. 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7908 

1 1/02/2012 

1     1  /  \J  L—l  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  V- /  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

PAMELA  SHEPPARD 

1    I  \  1  v  1 1  l—t  \   yS  1   1 1  1     1     /  \  1  I  IS 

SANOFI  PASTEUR  -  IVERMECTIN  (SKLICE^  LOTION  NDA 

Vw/  /  vi  *j  \w/ 1    i  i    /  v  Vw/  i  i  \s  ii       iv  i  i  1 1  v  1 1— _  \w/  i  1 1  vi  i  \s  i  \  ^  i  Vw/ 1  j  i_  \w/  i  i  Vm/  i  vi  in  L-/  i  \ 

12/03/2012 

1  L—l  Uu/  C-\J  1  t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \_/  1— /  1  1  1/  W  III    /  [_/  1 1  '  1  / 

TARO  PHARMACEUTICALS  USA 

i  ni  IV-'  i   i  1 1  \ i  1 1 v \  \j  \  iv/r\i  vj  uun 

202-736  SBA,  MOR,  LBLG,  ETC 

FnA/OMPT/nnFR/DRP/ninp/ 

r  vj r\i  v_/ivi n  i  /  o i— /  r__ rv v_/ i  \ i  /  i— / i \s \  i 

INC 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-7909 

11/02/2012 

FDA/OGROP/ORA/PA-FO/SEA- 

Jim  Gearhart 

WESTERN  INSTITUTIONAL  REVIEW  BOARD  -  CORR  WITH 

12/14/2012 

HA/OTA    /~i  r~)  / 

DO/SEA-CB/ 

QUORUM  REVIEW 

FDA  RE  NEW  REGULATIONS  (07/01/1981  -  06/30/1982) 

FDA/OMPT/CBER/OCOD/DDOM/ 

ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L_/  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

OC/COS/OES/ 

OC/COS/OES/ 

201  ^-791  0 

^  H  /AO/OA  ^  o 

rUA/UMr  1  /OUKH/UOtK/UrOI/ 

Paul  Lee 

K0908<i1 

12/03/2012 

Johnson  &  Johnson  Medical 

Products 

2012-7911 

11/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ADVATE  -  AERS  (01/01/2000  -  1 1/01/2012) 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Macquarie 

FDA/OMPT/CDER/ORP/DIDP/ 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

2012-7912 

11/02/2012 
12/03/2012 

FDA/OMPT/CTP/OD/ 

Aldridge,  Kevin 

CONTACT  INFORMATION  FOR  CIGARETTE  TUBE 
MANUFACTURER 

2012-7913 

1 1/02/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  /  /  V/  \w/  1  v  1  1      1  /  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

Mahadpv  Patpl 

ivia    quu  v   I  aivsi 

XYLO  CHEM  INDUSTRIES  NADIAD  INDIA  -  EIR  (07/01/2011 

/  \  1  l— Vw/    Vw/  1   1  1—  1  V 1    1  1  *l  IS  \J  \S  1  1  1 1  l__  \s  *    1  *l  1  V  IS  1 1  \  IS  ,    111  L/  1 1  \        1  III      1  v  /  /  v  1  /  C—\J  1  1 

12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

R&D  Support  Services  Inc. 

-07/16/2011) 

2012-7914 

11/02/2012 
12/03/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      1  /  \J  IS  1  1  1/  V_/  III    /  1— /  1  IS  1  / 

OM/OMP/DODM/ 

Dawn  M.  Chmielewski 

f^lim?ir,n  Wilrny  Pppp      r?i  nti  no  & 

\s WW  labU  V  V  l \       A  l   cua    I  al  al  nil  iu  ct 

Garofoli 

MIRENA  -  AERS,  DDMAC  CORR,  ADVISORY  COMMITTEE 
TRANSCRIPTS,  ETC  (01/01/2000  -  11/02/2012) 

201 2-791 5 

1 1/02/2012 
12/03/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1—/  / V/  \S 1 V  1 1      1  /  \  /  1  /  1  11   1  /  W  \J  1  1  l/L/l    Vw/  1  / 

.Iprk  Oohnnrn 

OaUt\  UUUUUI  1  1 

Jack  Cobourn 

CLOPIDOGREL  OR  TICLOPIDINE-ELUDING  STENTS  USED 

Ul  Vw/  1     1  is  Ks  \St  1  11  1       V_/  1  1     1  1  V  / 1  \s  |     1  l_Z  1  1  4  I        I  I  V/  |_/  I  I  "J  V_1    \J  1  1  IN  1  vJ    V/  V/  1  Is 

IN  ANGIOPLASTIES  -  AERS  (03/01/2008  -  03/30/2010) 

2012-7916 

11/02/2012 
12/03/2012 

OC/OM/OMP/DDM/ 

JEFF  GERTH 
PROPUBLICA 

DKT  1977N-0094L 

A  A  H  A  "7  A  H  "7 

201  2-791 7 

^  H  /AIT  /OA  ^  A 

1 1/05/2012 
12/04/2012 

rUA/UMr  1  /L-UKH/UOtK/UrOI/ 

KIGHAKU  KtLLtK 

BRUNO  INDEPENDANT  LIVING 
AIDS 

I  KAUt  L-MI-'LN  I  -  I  KAOKINCj  NUMBtH  Or  1 1 1 0021 1  OUHK 
5/1 2  TO  PRESENT 

2012-7918 

1 1/05/2012 

1    1  /  V/ i_f /  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

JOHN  CREWDSON 

\J  \-s  1   tl\    Vw/  1  1 1      V  V  IS  \_j  \s  1  v 

UNREDACTED  RPTS  OF  FAERS  (AERS)  1/06  TO  PRESENT 

KJ  1  ll  1 1  \S  1  \  V_/  1  1  IS    III      1  <S    Vw/  1       1    1  \  1— —  1  I V/    \  /  \  l_  1  I  V_J  I     \  1  \J\J     1  Vw/    1     11 1_  U  1  1  N  1 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

2012-7919 

1 1/05/2012 

1  1 1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1     IS  1  \l  \S  1  V  1  1       1  /  \S  IS  1       1    1/  W  III     /  I — '  1  ]  /  1  / 

ELIZABETH  BARBCHENN 

l__  1  1  L  1  \  1  }  1—  1  1   1    IS  1  I  1  1 1  >  \S  1   1  1—  1  >l  1  >l 

ISR  3157839  3767780  3775034  ETC 

1  S  1   l   U  1  /  /  L/  O  v/  .    v/  /  \J  1    <  *S  \J  *    vJ  /    /  <—?\J'*Jii    l_  1  V/ 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PUBLIC  CITIZEN 

2012-7920 

1 1/05/2012 

1  \  1  \J \JI  t—\J\i— 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1  v  1  1      1  /  \m/  IS  1  1  1/  \s  III    /  I — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MAHENDER  KORAPATI 

1  V  1  /  \  1    1  1  1  N  IS  1  1  I    1  \  \S  1  1 / \  1    1  \  1  1 

MEDCORE  PHARMA  LLC 

PFIZER  -ANTIVERT  (MECLIZINE  HCL)  ORAL  TABS  12  5  MG 

1     1     1  £  1  1  1      /  V 1  M  1   1  V  1— —  III     \  1  v  1  1  V/  1—  1  £  1  1  N  1— —    1   1  Vw/ 1—  /    Vw/  1  It  \  l_     1  /  V  E  /  O     1  L—  m  v_y    1 V 1  , 

25  MG,  50  MG  NDA  10-721  APRVL  RECS 

2012-7921 

11/05/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

NATHAN  A  BEAVER 

LIFESOUTH  COMMUNITY  BLOOD  CENTERS  9/10/10,  7/24/12; 

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Due  Date 


^  o  if\  a  /oo  ^  o 

12/04/2012 

DO/GHI-GB/ 

■ — /—s ■  i —  \ /  o  i  AnnMrn  i  i  n 

FOLEY  &  LARDNER  LLP 

a  i  i  n  t~\  n  a   a  ni —  i\  ni  f~\/~\  x~\  n  ami/  /urAHTi  akir\  h  m  a  14  r\. 

AURORA  AREA  BLOOD  BANK  (HEARTLAND)  1/14/10; 

FDA/OGROP/ORA/CE-FO/MIN- 

HEARTLAND  BLOOD  CENTERS  INC  1 1/28/1 1  ETC  -  483'S 

UO/IVIIN-OB/ 

WARNING  LTRS,  UNTITLED  ENFORCEMENT  LTRS,  ETC 

F  D  A/OG  ROP/0  RA/P  A-  FO/S  AN  - 

PvA/OAM  AP)/ 

UO/bAN-OB/ 

FDA/OGROP/ORA/SE-FO/ATL- 

rvA,/A"ri  ac>/ 

FDA/OGROP/ORA/SE-FO/FLA- 

nn/ci  a  aq/ 
UU/rl_A-Ob/ 

FDA/OGROP/ORA/SE-FO/NOL- 

DO/NOL-CB/ 

o  a  -i  o  ~7aoo 

-1  H  /AC  /OA  ^  O 
1 l/OO/iiOl  £ 

rnA  /a,c:/a  ccam  /a.  a  pv  /c:  a,o  / 
rUA/Ur/OrbAN/UOIJ/bUb/ 

□  CTUAMV  \Af  A  |   1  O 

bb  1  HANY  WALLo 

PJDA  IMPVI  ICTDICC        AA  DAI  VIlAED  Ac  IIACTU  A  A  P}\/l  IA  AAIPV 

rrO  INUUb  1  rilbb  -  OU-rULYMbK  Ur  ME  1  HAOriYLIO  AOIU, 

12/04/2012 

Intprtpk  Ohpmiral^  3nd 

1 1  1  Lv_/  1  Vw / 1  1 1  1  1  IvdlO   CI  1  1 VJ 

ETHYL  ACRYLATE,  STYRENE,  BUTYL  METHACRYLATE  & 

Pharmaceuticals 

GLYCIDYL  METHACRYLATE  FCN  1177 

2012-7923 

11/05/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMTH 

CAERS  142534,  144083,  144598,  ETC 

12/04/2012 

I0VATE  HEALTH  SCIENCES 

IMTCDM  ATIAMAI  IMP 

IN  1  bKNA  1  IUNAL  INU 

o  a  -i  o  Trio  A 

■(  -(  /AP  /OA  ^  o 

1 1/05/^0  \2 

rn*  /rjc/PCC  A  N 1  /A  A  pv  /CAO  / 

rUA/Ur/OrbAN/UOD/EOb/ 

MONbTER  ENERGY  DRINKb  -  OAERb 

■1  O  /Ayl  /OA  ^  O 

ARAMC  IAPI/CAM 

AUAMb,  JAUKbUN 

o  a  -i  o  7noc 
d\J\  2-/i)2.0 

4  H  //![■  /OA  ^  O 

1 1/0o/<;01  2 

rnA  /a,c:/a  ccam  /a  a  pv  /c:  a,o  / 
rUA/Ur/OrbAN/UOIJ/bUb/ 

DAT — TV  1  /"M/CDA 

PA  1  1  Y  LOVbnA 

AIAEDIPAM  Pvl  A  P>\/  DDAni  l/^TC  IMCTITI  ITC  0   Tl_l  C  1  IO  PVAIOX/ 

AMbKIOAN  UlAriY  rHUUUO  1  b  INb  1  1  1  U  1  E  &  1  HE  Ub  UAIKY 

^  O  /Ayl  /OA  ^  O 

1  2/W/2VI  2 

rood  &  water  watch 

EXPORT  COUNCIL  -  GRASS  NOTICE  444  MILK  PROTEIN 

CONCENTRATE  &  MILK  PROTEIN  ISOLATE  9/25/12 

2012-7926 

11/05/2012 

FDA/00/0FBA/0AGS/ 

PAYAL  TAK 

CHICKASAW  NATION  PROFESSIONAL  SERVICES  INC  (SRA 

12/04/2012 

TELESIS  CORP 

INTERNATIONAL  INC)  -  HHSF2232009500261 

2012-7927 

11/05/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CHRISTY  CASPERS 

COPPERLEAF  KITCHEN,  ALEXANDRIA,  MN  -  NONPUBLIC 

12/04/2012 

r-OPPFRL FAF  KITCHEN 

\S V-/  1    1    1  1  1 1  1  I  \ 1      l\l  1  \J\  II  1  M 

RECS  NAME  OF  FIRM,  LTR  DESTROY  ALL  HARD  COPIES 

OO  H  O  TOO  O 

rnA  /ap  /  a cp  a  m  /a  a pv /r  ac  / 
rUA/Ur/OrbAN/UOD/EOb/ 

MERLE  ZIMMERMANN 

Ml  ITD  A    A/IAMI  ICA  ATI  IDIMA     A  PJ  PT  PT  M\ / 1 1  1   PT  OA  O /O  O /H  H  ■  Pi/AI 

NU  1  KA  MANUrAO  1  UKINO:,  UHEEN VILLE  bO  0/0-0/1 1 ,  EVUL 

12/05/2012 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 

AMERICAN  HERBAL  PRODUCTS 

NUTRITION  KENNESAW  GA  7/1 3-29/1 1  ■  VALENTINE 

1  >J        1  1  1 1  1  1  V_/l  >J  ,    1  \  1  1  >J  1  >J  1  Wf  \  V  V  ,         I  \    f  1  1  \J    C-\JI    1    1  ,     V  1  \  1  1  1  N  1  1 1  M  1  

PvA/P>l  "T  AP)/ 

UO/BL 1  -OB/ 

AboOCIA  1  ION 

ENTERPRISES  INC,  LAWRENCEVILLE,  GA  10/5-11/11,  ETC 

EIRS,  483S 

FDA/OGROP/ORA/CE-FO/CHI- 

r^^~\ i_i  i  on/ 

DO/0  HI -OB/ 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

F  D  A/OG  ROP/0  RA/C  E-  FO/D  ET- 

DO/DET-CB/ 

FDA/OGROP/ORA/CE-FO/MIN- 

DO/MIN-CB/ 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OC/OES/DFOI/ 

oaha  taaa 

^  ^  /AIT  /OA  ^  A 

1 1/05/^0  \2. 
12/04/2012 

rUA/Ur/OrbAN/UGD/tUb/ 

a  iv  i  f**  i —  i   a  ou \/~r i_i 

ANGELA  bMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

LOVATE  -  HYDROXYCUT,  bMARTBURN,  RAPIDbLIM  & 
RAPID  SLIM  ETC  CAERS  8/2/1 2  TO  PRESENT 

2012-7930 

1 1/05/2012 

1     1  /  \J\JI  L—\J\l— 

ORA/ 

RICHARD  D  NEWMAN  PHD 

1  l  1  W  1    1  /  \  1   V  1  /           1  N  1—  V  V  1  V  1  /  \  1  N    1     II  L-/ 

AMERIDOSE  LLC  -  483S  2012 

12/04/2012 

ORA/ 

RND  SERVICES  LLC 

2012-7931 

1 1/05/2012 

1  \  1  \J \JI  t—\J\i— 

12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rphpppq  PinP 

■  IvUbuuU    1     II  1  \j 

Rebecca  K  Pine 

K083767 

2012-7932 

11/05/2012 
12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Trishia  Dwyer 
GE  Healthcare 

K1 13356 

2012-7933 

11/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Leola  M.  Anderson 

K921224 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

GERTLER  LAW  FIRM 

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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  W  l_/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-7934 

1 1/05/2012 
12/04/2012 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    VwX  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   WLILL    ^UVJLV/U  / 

MERCK  &  CO.,  INC. 

FOI  DAILY  LOG  10/1-31/2012 

1    Vw/  1    L/  /  VI  1       1     L_  Vw/  V^/1       IV//    1     V/  1  /  £—  V/  1  L_ 

2012-7935 

11/05/2012 
12/04/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt(UG2CD-16) 
MERCK  &  CO.,  INC. 

CLOSED  FOIA  REQUESTS  10/1-31/2012 

2012-7936 

1 1/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — /  1  \!  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  1 — f  I  J  /  I  / 

INDIVIDUAL  RECS 

1  1  N  L/  1  V  1  1  /  V/  /  \  1       1  1 1_  V/  Vw^ 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-7937 

1 1/05/2012 

1  1  /  \J \JI  t—\J\i— 

12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

I  aurip  Oartwrioht 

i-ciui  i v/ai  lvv i  iui  ii 

ARTHROCARE  CORP 

K1 20543 

l\l  i_  W  ^/   i  o 

2012-7938 

1 1/05/2012 

1     1  /  \J\JI  L—\J\C— 

12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  \J  l—s  1  11   1/  Vw/  V/  l_  1  1/  1  /  1    Vw/  1/ 

I  a i  irip  Oartwrinht 

I—  QUI  \\j    WC1I  LVV  1  iyi  11 

ARTHROCARE  CORP 

K1 12040 

1  V  I    1  £_  v/  v/ 

2012-7939 

1 1/05/2012 

1  \  1  \J \JI  t—\J\i— 

12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L*S  1  11   1/  V_/  Vw /  l_  1  1/  1 — /  1    Vw/  1/ 

Frin  MrCnv 

i  i  ii  i  iviVri/VwSV/y 

Tampa  General  Hospital 

K121679 

l\l^  IV//  ^/ 

2012-7940 

1 1/05/2012 

1     1  /  \J\Jl  L—\J\L— 

12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

1  aurip  Oartwrinht 

1 — ClU  i  IC    WC1I  LVV  1  IUI  IL 

ARTHROCARE  CORP 

K101823 

l  \  1  v  1  V/  £_  Vw* 

2012-7941 

1 1/05/2012 
12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  11   1/  V_/  \w/  l_  1  1/  1 — /  1    Vw/  J/ 

1  aurip  Oartwrinht 

1 —  Cimi  1  V>    V_/dl  LVV  1  IUI  IL 

ARTHROCARE  CORP 

K1 03831 

1  x  1  UvJUJ  1 

2012-7942 

11/05/2012 
12/04/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Laurie  Cartwright 
ARTHROCARE  CORP 

K1 20078 

2012-7943 

1 1/05/2012 

1  \  1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  1 — '  1  J  /  1  / 

Monira  Hun 

1  V  1  V/  1  1 1  KjCX   1  IUU 

ANDA  071739  -  SBA 

1  VI  ^1  L/  /  V  V/  /    1  /  V/  \J        V/ /  V 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Merck  Consumer  Care 

2012-7944 

11/05/2012 
12/04/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Doug  Iten 
WFTS  TV 

MONSTER  ENERGY  DRINK  -  AERS  (01/02/2007  -  1 1/01/2012) 

2012-7945 

1 1/05/2012 

1     1  /  \J\JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

.Ipnnifpr  Milp^ 

\J  \j  1  1 1  1 1 1  \j  1    IVII 1 V-/  o 

SULFASALAZINE  -  AERS  WARNINGS  CORR  ETC 

\J  V/  1—  1    /  \  \-J  1  \  \  1  \  i.  1 1  M  1            I  \  \—  1  I  \-J    V  V  1  V 1  II  N  1 1  v  \**A  \—f  ,    Vw/  Vw/  1  1 1  1    1       1  V/ 

12/04/2012 

1  L—t  V/     W  L —  y/    1  L — 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Frazer,  Greene,  Upchurch  &  Baker, 
LLC 

2012-7946 

11/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Laura  Boll 

K111821 

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Subject 

12/04/2012 

Medovations  Inc. 

2012-7947 

1 1/05/2012 

1     l  1  W \JI  C—\J\L— 

12/04/2012 

ORA/OCI/ 

Vw/  I  1 1  \j  \_/  v_/ 1  / 

ORA/OCI/ 

.lakp  Ppar^on 
Wired  Magazine 

GOOGLE  INC  ONLINE  ADVERTISEMENT  OF  PHARMACIES  - 

Vw/  Vw /  Vwi  1  l_    1  1  M  \w/   Vw/  1  N  I—  1  1  il  1        /  V  L/  V  1  1  1  1  1  V/  1— —  1  v  1  1  1  t|  1     Vw/  1       III  /  \  1  1 1  VI/  \W  1  1— —  V/ 

2009  INVESTIGATION  RECS 

2012-7948 

11/05/2012 
12/04/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

ALLERGAN,  IRVINE,  CA  -  EIR  05/24/2010;  EIR  04/04/2008 

2012-7949 

1 1/06/2012 

1  \  1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — /  I  ]  /  I  / 

Matt  Danipl 

iviau  i — ' ci i  ii^i 

NCT01 577654  NCT01 170650  -  ISRs 

1  *J  Vw/  l  \J  \  \J  1    l  \J v/      3    1  M  V- /  \  \J  \    \  1  \J\J\J\J        1 V/ 1  lO 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Prosight  Capital 

2012-7950 

11/06/2012 

ORA/ 

Mike  Pagano 

KRAFT  GREEN  GODDESS  SALAD  DRESSING  -  SAMPLE 

12/05/2012 

ORA/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

Kraft  Foods  Global  Inc. 

RESULTS 

2012-7951 

L_ v/  1  £_     /  \J\J  1 

1 1/06/2012 

1  1  /  \J\JI  t—\J\i— 

12/05/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Chri<;  Lahiff 

\J  1  J  1  1  O    1  Cl  1  1 1  1  1 

McDermott  Will  &  Emery  LLP 

MONSTER  ENERGY  DRINKS  -  CAERS 

1 V  1  Vw/  1  M  \_/  1  l_  1  1    1  1  v  1  1  I         1      L/  1  1  1  1  M  1  \  v_/          V  *  1  \  1  1  I V/ 

2012-7952 

11/06/2012 
12/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Dari  Darabbeigi 

Persyst  Development  Corporation 

K090019,  K092039,  K1 20485  ETC 

2012-7953 

1 1/06/2012 

1     1  /  \J\Jl  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

Rarhpl  .Inhn^on 

1  ldV.fl  lul   \J\J\  II  IOUI  1 

NDA  202428 

1  ML//  V   i_  w  t_    T  £  W 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  (_/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-7954 

11/06/2012 
12/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Mark  Patterson 
Lila  Enterprise,  LLC 

K1 1 1 501 

2012-7955 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Bruce  Thompson 

ISR  10482  10470  10471,  ETC 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

Bruce  Thompson 

2012-7956 

1 1/06/2012 

1  \  1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  (_/  1  1  /  1  / 

Danipl  C^ofman 

L/  CI  1  1 1  \j  1    Vw^  \J  1  1  1  1  CI  1  1 

GASTROINTESTINAL  DRUGS  ADVISORY  COMMITTEE 

\—A  1  V  Vw/  1  1  I  Vw/  II  N  1  1  U  1  1  1  *J  /  V  l—    L/  1  I  Vw/  V_/  V_/   /  V  J  /  V  1  V_/  Vw/  1  1  1     Vw/  Vw/  1  V 1 1 V  1  1  1     1  1— —  l_ 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SERRADO  CAPITAL  LLC 

TRANSCRIPT  10/16/12 

2012-7957 

11/06/2012 

OC/OOPD/ 

Diane  Schulman 

TETRACOSACTIDE  HEXAACETATE  -  ORPHAN  DRUG 

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Pnntrnl  if 

rit?OU  Udlc  / 

HO  HUM  UIIIOc 

OlyildLUlu/  ritjLjUubLci 

Ci  1  1  ["HQ/it 

ouujfcfoi 

Due  Date 

12/05/2012 

FDA/OMPT/OSMP/OOPD/ 

The  Indago  Group  Inc. 

APPLICATION 

2012-7958 

11/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Daryl  Davis 

BURZYNSKI  RESEARCH  INSTITUTE  -  DSI  SUMMARY  OF 

12/05/2012 

FnA/OMPT/nnFR/DRP/nmp/ 

\-J  CI  v  1  o ,  1— '  qi  y  1 

FINDINGS  08/01 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/bW-FO/DAL- 

DO/DAL-CB/ 

2012-7959 

1 1/06/2012 

1  \  1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

ANASTROZOLE - AER 

12/05/2012 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  / V/  Vw/ 1  v  1 1     1  /  1— /  1  1  1/  V-/  III    /  l_/  1  i  '  1  / 

Dog  J 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/nMPT/nnFR/nRP/nmp/ 

2012-7960 

11/06/2012 

ORA/ 

JOHN  L  HOLAHAN 

SIMPLY  THICK,  WAKE  COUNTY,  NC;  ST  LOUIS,  MO  -  SPL 

12/05/2012 

ORA/ 

bIMPLY  THICK  LLC 

656840,  TEST  RESULTS  6/201 1 

FDA/OGROP/ORA/bW-FO/KAN- 

nn/KAN-r;R/ 

2012-7961 

1 1/06/2012 

ORA/ 

H  n  a  nil  \/K  1 K  1  \A/UITM  1 —  \/ 

MARILYNN  WHITNEY 

TOBACCO  MFRb  -  EIRb,  483b  AFTER  9/1 1 

12/05/2012 

ORA/ 

COVINGTON  BURLING  LLP 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 

DO/BLT-CB/ 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

FDA/OGROP/ORA/SE-FO/ATL- 

DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 

DO/NOL-CB/ 

2012-7962 

11/06/2012 

FDA/OMPT/CTP/OD/ 

MARILYNN  WHITNEY 

LIST  OF  TOBACCO  PRODS  FOR  WHICH  FDA  ISSUED  A 

12/05/2012 

COVINGTON  &  BURLING  LLP 

SUBSTANTIAL  EQUIVALENCE  ORDER;  SUMMARY  OF 

AnVFR^F  HFAI  TH  FFFFP.TC! 

^(J1  ^-/abo 

11/06/2012 

rUA/UunUr/UKA/ob-rU/r  LA- 

JOELLE  G.  NELSON 

1  UAIN  1  bL/HNULUljY  INO  -  AU  1  IVb  rHAriMAObU  1  IL>AL 

12/05/2012 

DO/FLA-CB/ 

JOHANSON  &  FAIRLESS  LLP 

INGREDIENT  (API)  TESTING  LAB 

2012-7964 

11/06/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

SUSAN  B.  MILLS 

E  COLI  OUTBREAK  AT  CLEVELAND  CO  (NC)  FAIR  FROM  9/27 

12/05/2012 

DO/ATL-CB/ 

WEINBERG  WHEELER  ET  AL 

TO  10/7/12  -  INVESTIGATION  RECS,  SPL  SUMMARIES, 

TRACE  BACK  DATA,  ETC 

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2012-7965 

11/06/2012 
12/05/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  lw/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1— /  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

KEVIN  M.  DWYER,  Jr. 

LAW  OFFICE  OF  KEVIN  M 
DWYER  JR 

L/  V  V    1   1  1   1   vJ  1  1 

HARVARD  CLNCL  TRIAL  RESEARCH  INSTITUTE  12/09 
INVESTIGATION  OF  THE  FAILURE  TO  REPORT  A  SEVERE 
ADVERSE  EVENT  (SAE) 

2012-796(5 

1 1/06/2012 

I  I  /  \J\JI  C-\J  I  c 

12/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— / 1  \i  \w/ 1 V  1 1      1  /  \_/  L/  1  11   l,V_/V_/[  1  1/        1    Vw/  1  / 

EILEEN  BOYLE 

1  1 1  1  1  IN    1  '  V/  1  1  1  

HOLOGIC  INC 

MEDIMAPS  GROUP  SA  -  TBS  INSIGHT  K121716 

1 VI 1  L/  1 1  V  1  n  1     \J   V  \  1  \  V  '  VJ  1       w/\          1  1  vJ    1 1  M  \J  \  \-A  III     W  \  C-  I  1    1  \J 

2012-7967 

1 1/06/2012 

1     1  /  \J\JI  L-\J   1  C 

12/05/2012 

FDA/OF/CFSAN/OOD/EOS/ 

WALBAUM,  RICHARD 

NERIUM  INTL  LLC  -  NERIUM  AD  AGE  DEFYING  TREATMENT 

INI  1  IIUIVI    1 1  M  1  1       1  INI  1  IIUIvl   i  V  L/   r\VJ  1        lw/  1  1      1   1  1  N  \~\     1  1  11  1  \  1  IVII  INI  1 

AER8/11  TO  PRESENT 

2012-7968 

1 1/06/2012 
12/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  lw/  1  11   1/  v^/  \-J  1—  1  1/  1 — /  1    Vw/  1/ 

EILEEN  BOYLE 

1  1  L_  1  1  1  v    1  >  V_/  1  1  l_ 

HOLOGIC  INC 

ON  DIAGNOSTICS  -  VIRTUOST  K1 13725 

Vw/ 1  i|    lw/  It  V\J  1  M  V_/        1   1  Vw/  Vw/         Villi  Vw/  Vw/  Vw/  1     l\l    1  Uf  LvJ 

2012-7969 

11/06/2012 
12/05/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

BERRYMAN,  THOMAS 

UROMED  PATCH  K974600 

OAHO  "7ri"7A 

201 2-7970 

1 1/06/2012 

rUA/OMr  1  /L-UKH/UOtK/UrOI/ 

YVUNNt  M.  rLAHtKIY 

n  a  n  a  r*\ i     r  ji  /™\ i  1 1 o  1/  01 — r  1  n  1  ^1  10 1  f\ k  i  01 — r 0  i/ahha^h      ■  a  0 0  1 

PARADIGM  QUICK  SET  INFUSION  SETS  K01 1 071  CLASS  I 

12/05/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

LOCKRIDGE  GRINDAL  NAUEN 
PLLP 

RECALL  ACTION  MEMO 

2012-7971 

1 1/06/2012 

1    1  /  V/  V//  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \  '  L/  1  1  1/  V_/  III    /  1— /  1  ]  /  1  / 

JANUVIA  -  AER 

\j  i  \  i  n  Vw^  v  1 1  v      I  \  i__  i  i 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-7972 

1 1/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

GLADYS  B  TONKINS 

V_/  1  I   \  L/    1   V/    I—'      1   V_/  1  >l  1  \  1  1  N  Vw/ 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  10/15-19/12 

1    Vw/ 1    lw/  /  V 1  L_  1     LV/vl     1  V/  /   1  xj     1  v//    1  £_ 

2012-7973 

1 1/07/2012 

1     1  /  \J  I  1  L—\J   1  I— 

12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

\—A  1  I  \  L/   1  V/    I  >     \  Vw/  1  *l  1  V  1  1  *J 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  10/8-12/12 

1    Vw/  1    lw/  /  V 1  L_  1     L_  Vw/  V/     1  \J/ \J     1  ^/    1  L_ 

2012-7974 

1 1/07/2012 

1    1  /  \J  1  1  t—\J  1  i— 

12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

GLADYS  B  TONKINS 

v_/  1  1  \  L/   1  V/    I  J     1  V_/  1  >l  1  \  1  1  N  V/ 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  10/22-26/12 

1    Vw/  1    lw/  /  VI 1       1     L_  Vw/  V/     IV//  £—  t—    L—  v//    1  t— 

2012-7975 

1 1/07/2012 

1    1  /  W  /  /  t_  v/  1  t— 

12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

\—A  1  I  \  L/   1           I  >     \  Vw/  1  *l  1  V  1  1  *J 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  10/1-5/12 

1    Vw/ 1    lw/  /  V 1  L_  1     LV/VJ     1  \J  1   1     \Ji    1  C— 

2012-7976 

1 1/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

BARBARA  JONES 

1  '  1  \  \  1 1  1 1  \  \  \  I  \  \j  Vw/ 1  *J  1  

DOMINION  GROUP  INC 

FOI  DAILY  LOG  10/15-19/12 

1    Vw/  1    lw//  V 1  1—  1     l—  Vw/  V/     1  v//   I  v/     1  \JI    1  t_ 

2012-7977 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

FOI  DAILY  LOG  10/22-26/12 

2012-7978 

11/07/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 

FOI  DAILY  LOG  10/1-5/12 

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Total  Records:  9990 


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12/06/2012 

DOMINION  GROUP  INC 

2012-7979 

1 1/07/2012 

1    1  /  \J  1  1  t—\J  1  £_ 

12/06/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 

1  '  1      \  \       l  I  1 1      \  \       \  1      \      \J  Vw/  I     *J  1  

DOMINION  GROUP  INC 

FOI  DAILY  LOG  10/8-12/12 

1    Vw/  1    l_//  V 1  L_  1     L\/ vi     1  V/  /  V/     1  ^1    \  C— 

2012-7980 

1 1/07/2012 

1     1  1  \J  1  1  L—\J   1  I— 

12/06/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \     \  1  \  1   V  1  1 1       V_/  1  N         V_/  1   1  1  1 1  \  1  V 1  1 

CanReg,  Inc. 

FOI  DAILY  LOG  10/22-26/12 

1    Vw/  1    l_/ /  V 1  L_  1     LV/ v^     1  \J  1  C—  C—    L—  \jl    \  L— 

2012-7981 

1 1/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

FOI  DAILY  LOG  10/1-5/12 

1    Vw/ 1    l_//  V 1  L_  1     L_  Vw/  V^l     1  \JI   1     \J1    1  L_ 

2012-7982 

1 1/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \      \  t   \  1   l  1   l  1  v_/  V_/  1  >l     V_/  V/  1    1  1    l/»  1  V  1 1 

CanReg,  Inc. 

FOI  DAILY  LOG  10/8-12/12 

1    Vw/  1    l_//  V 1  L_  1     L_  Vw/  V^l     1  \JI  \J     \  ^/    1  L_ 

2012-7983 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

FOI  DAILY  LOG  10/15-19/12 

2012-7984 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/8-12/12 

2012-7985 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/15-19/12 

2012-7986 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/1-5/12 

2012-7987 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/1-5/12 

2012-7988 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/22-26/12 

2012-7989 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  10/22-26/12 

2012-7990 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  10/1-5/12 

2012-7991 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  10/8-12/12 

2012-7992 

11/07/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

FOI  DAILY  LOG  10/15-19/12 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
r^i  i a  r^ato 

Action  Office 

Signature/  Requester 

Subject 

12/06/2012 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

2012-7993 

1 1/07/2012 

ORA/OCI/ 

A  CARIN  WEINRICH 

INDIVIDUAL  RECS 

1   1    N  I— *    1      V      1   1  '    Vw*  l\  1               1       I  I—  Vw/  Vw^ 

12/06/2012 

ORA/OCI/ 

SOREFF  LAW 

2012-7994 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

PAUL  W  TRIPP 
LINCARE  INC 

GOLDEN  SANDS  RESPIRATORY  CARE  SERVICES  INC,WI  - 
EIRS,  483S,  WARNING  LTRS  1/05  TO  PRESENT 

2012-7995 

11/07/2012 
12/06/2012 

ORA/ 
ORA/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

LOU  CAPUTO 

EMORD  &  ASSOCIATES,  P.C. 

BLIS  TECHNOLOGIES  LTD  -  BLIS  K-1 2  TRAVEL  GUARD 
IMPORT  REFUSAL  NOTICE  OF  DETENTION  &  HEARING 

2012-7996 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

LESLIE  SHOJI 

INTEREX  INDUSTRIES  LTD 

UNITED  1  INTERNATIONAL  LABS,  FARMERS  BRANCH,  TX; 
CEUTICAL  LABS,  FARMERS  BRANCH,  TX;  MICROCONSULT 
INC,  CARROLLTON,  TX,  ETC  -  EIRS 

2012-7997 

1 1/07/2012 

1     1  /  \J  1  1  L—\J   1  I— 

12/06/2012 

FDA/OO/ 
FDA/OO/OHR/ 

JOHN  SANDERS 
BENEFIT  COORDINATORS 

LIST  OF  FDA  EMPLOYEES  -  SUBORDINATE  ELEMENTS 

1  1  v_/  1     \  '  1       1     1  '  1  \    l__  1  V 1  1     1  \  '    1   1  1  U        vj  \-/  \  '  vy  1  I  L*S  1  1  HI  \  1  1        l__  1  l_  1 V 1  1— —  1  VI  1  K-f  , 

AGENCIES,  FIELD  COMPONENTS,  ETC 

2012-7998 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

SUSAN  B  MILLS 
WEINBERG  WHEELER  ET  AL 

CLEVELAND  COUNTY  (NC)  FAIR  -  E  COLI  OUTBREAK  EIRS, 
TRACE  BACK  DATA  SPL  SUMMARIES  ETC  9/27/12-10/7/12 

2012-7999 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

SHANDIN  KLOBE 

BAKER  STERCHI  COWDEN  & 
RICE  LLC 

NEVADA  HEART  AND  VASCULAR  CENTER.  LAS  VEGAS,  NV 
-  PET  SCANS  INVESTIGATION  RECS,  INSP  FINDINGS, 
CORR,  ETC  1/05  TO  PRESENT 

2012-8000 


2012-8001 


11/07/2012 
12/06/2012 

11/07/2012 
12/06/2012 


FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 


FDA/OC/OES/DFOI/ 


SHANDIN  KLOBE 

BAKER  STERCHI  COWDEN  & 
RICE  LLC 

JEFFREY  J  JONES 
JONES  DAY 


NEVADA  HEART  AND  VASCULAR  CENTER  (LONGFORD 
MEDICAL  CENTER),  LAS  VEGAS,  NV  -  PET  SCAN 
INVESTIGATION  RECS,  CORR,  VIOLATIONS,  ETC  1/05  TO 
PRESENT  

SCOTTS  MIRACLE-GRO  CO  -  WILD  BIRD  FOOD  PRODS 
RECS  1/08  TO  PRESENT 


2012-8002       11/07/2012  CVM/OCD/ 

1 2/06/201 2  FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
 DO/DAL-CB/  

2012-8003       11/07/2012  FDA/OF/CFSAN/OCD/EOS/ 

12/06/2012  FDA/OGROP/OIP/ 


JEFFREY  J  JONES 
JONES  DAY 


INDIVIDUAL  RECS 


PATTI  WALLER 
MARLER  CLARK  ATTYS 


TANIMURA  &  ANTLE  INC  -  ROMAINE  LETTUCE  RECALL 
COMM 


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Total  Records:  9990 


Pnntrnl  if 

rit?OU  Udlc  / 

Due  Date 

HOUUI1  V-MMOc 

Cinno+i  iraf  Poni  iqc+qi* 
OlyildLUlu/  ritjLjUubLci 

Ci  i  il^iia/it 
OUUjfcJGl 

ORA/ 

ORA/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

2012-8004 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

Doe  J 

RULES,  REGULATIONS  ABOUT  GLUTEN  IN  FOODS 

2012-8005 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS 1  \l  Vw/  1 V  1  1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/COS/OES/ 

OC/COS/OES/ 

LISSETTE  HOWARD  POCHE 

UNIV  OF  TEXAS  MD  ANDERSON 
CANCER  CENTER 

ROBERT  E  YOUNG  MD  -  CLNCL  INVESTIGATOR 
DISQUALIFICATION  PROCEEDINGS  10/15/82 

2012-8006 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-OB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

ALAN  G  MINSK 

ARNALL  GOLDEN  GREGORY  LLP 

BENJAMIN  BIOMEDICAL  INC,  ST  PETERSBURG,  FL  -  EIRS, 
CORR  2007 

2012-8007 

11/07/2012 

ORA/ 

JONATHAN  M  RIVERA 

GOYA  FOODS  INC  -  CMPLNT 

12/06/2012 

ORA/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

MANUEL  A  ROMERO  PC 

2012-8008 

1 1/07/2012 

1  1  /  \J  1  I  t—\J  1  t_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  L*/  1  1— '  1  / 

ANDY  WU 

I  \  1  >l  IS   1      V  V  \J 

ORANGE  BOOK  1980  TO  PRESENT 

\s  1  1 1  V 1  M        l_    IS  \S  \S  1  \     1  \J\J\J     1  Vw /    1     1  1 1  1  1  i|  1 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIV  OF  PENNSYLVANIA 
WHARTON  SCHOOL 

2012-8009 

1 1/07/2012 

1    1  /  \J  1  1  t—\J  1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/        III    /  I — '  1  IS  1  / 

Matt  Danipl 

IvIdlL  1— /CLI  llwl 

VINTAFOLIDE  -  AERS  (01/01/2000  -  11/06/2012^ 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \S  1 V  1 1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1 1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Prosight  Capital 

2012-8010 

11/07/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Liz  Pretzinger 

INDIVIDUAL  RECS 

12/06/2012 

ALFB/ 

Rawls  McNelis  +  Mitchell 

2012-8011 

11/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

AZITHROMYACIN  -  AERS  (01/01/1996  -  11/06/2012) 

Page  91  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  1  \l  Vw/  1 V  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

McNerney,  Jon 

2012-8012 

11/07/2012 
12/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CAPSTONE  LLC 

MONSTER  ENERGY  DRINKS  -  AERS  (01/01/2009  - 
11/06/2012) 

2012-8013 

11/07/2012 
12/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  I—/  1  1  1/  V_/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Tammy  Covert 

Simon  Oirppn^tonp  Pan^tipr 

\J  1 1  1  1  V/  1  1    V/  1           1  1  O  L  V/ 1  1  \j    1     CI  1  1  d  Uvl 

Bartlett,  PC 

TOLUENE,  HYDROQUINONE  IN  HAIR  AND  NAIL  PRODUCTS 
-  CORR  WITH  COLOMER  BEAUTY  BRANDS  USA,  INC., 
CREATIVE  NAIL  DESIGNS,  INC,  LOREAL  USA,  ETC 

A  A  H  A  Of\A  A 

dQ\  ii-801 4 

^  ^  /A  "7  /A  A  ^  A 

1 1/07/^01<i 
12/06/2012 

rUA/Ur/OrbAN/UGD/tUb/ 

Cdn  Cosmetic  Toilatry  and  Frag 
Assoc. 

b  I  UUY  bUBMI  I  I  tU  I  U  rDA  BY  OObMt  I IC,  I  UILt  I  KY  AND 
FRAGRANCE  ASSOCIATION  -  ABSORPTION  DISTRIBUTION 

1     1  1 1  \  Vwi  1   V  i  \  1  VI  Vw/  1— —  1  \  V_J  U  Vw/  v/  1 1  \  1   1  \mmJ  1  N        I  \  1  )  \mmJ  Vw/  III      II  Vw/  1  VI  j    L/  1        1  1  1  1  I— J  V/  1  1  Vw/  1  V|  ^ 

METABOLISM  AND  EXCRETION  OF  RED  NO  9 

2012-8015 

11/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 

K831004 

12/06/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-8016 

1 1/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \-S  L/  1  1  1/  V_/  III    /  t — '  1  1— /  1  / 

.la^on  Mallari 

UOOUI  1    IVIC4IICU  1 

CRESTOR  -  AERS  (08/29/2003  -  1 1/06/2012) 

V/  1  I l__  V/  1  Vw/  1  1        / \  l_  1  1  U    \  V/  V//  t_  v//  t_  V/  V/              1    1  /  V/  V//  £-  V/  1  £_  J 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vh*/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Regis  University 

2012-8017 

1 1/07/2012 
12/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  \w/  1    /  V/  1    v//\  1  N/  Vw/  Vw/  1  /  /  l_  Vw/  V-J/ 

Paulina  Do 

1     UUIII  Id    1—/ KJ 

EXPONENT 

CAP  4C0276 

V/  /  11           V/  V/  L—  1  \j 

2012-8018 

11/07/2012 
12/06/2012 

FDA/OC/OES/DFOI/ 

FREIFELDER,  JACK  FRANCIS 

FOI  REQUESTS  9/1/12-10/1/12 

2012-8019 

1 1/07/2012 

1  1  /  \J  1  I  t—\J  1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  ( — /  1  1  /  1  / 

MICHAEL  R  COHEN  RPH  MS  SCD 

1  v  1  1  Vw/  1   1 1  \  l__  L_   1  I    Vw/  Vw/  1   1  l__  1  *J    III     II    1  V 1  VwJ   Vw/  Vw/  1 — ' 

MEDWATCH  RPTS  CODED  AS  MEDICATION  ERRORS  10/1- 

1 V  1  1  l_/  V  V  1  \  1  V/  1   1    1  1 1      ]  Vw/    V/  Vw/  1 — /  \  1  /   /  \  V/    1  V 1  1  1 — /  1  \—t  1  \  1  1  Vw/  1  VI    1  1  1 1  L  Vw/  1  I V/     1  U/  1 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INSTITUTE  FOR  SAFE 
MEDICATION  PRACTICES 

31/12 

2012-8020 

11/07/2012 
12/06/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

DARI  DARABBEIGI 

PERSYST  DEVELOPMENT  CORP 

NATUS  MEDICAL  INC  -  NATUS  NEUROWORKS  K090010; 
OPTIMA  NEUROSCIENCE  INC  -  IDENTEVENT  K092039; 
MOBERG  RESEARCH  INC  -  COMPONENT 
NEUROMONITORING  SYS  K080217,  ETC 

2012-8021 

11/07/2012 
12/06/2012 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

CHARLES  CELESTE 
EAS  Consulting  Group,  LLC 

NOVARTIS  VACCINES  &  DIAGNOSTICS,  EMERYVILLE,  CA  - 
483SS4/12TO  PRESENT 

2012-8022 

11/07/2012 

ORA/OCI/ 

INDIVIDUAL  RECS 

Page  92  of  895 


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Total  Records:  9990 


Pnntrnl  if 

ntiOU  L/cUc  / 

HO  HUM  wlllOc 

oiyiidLure/  rietjUebLci 

ouujeoi 

Due  Date 

1  CI  \J\Jl  C\J  \  (— 

Dnp  1 

2012-8023 

1 1/08/2012 

ORA/ 

steve  caritis 

/~» f.  k  r—\  /~\  i  iMnrn  ma  i/cm  a      i  ad  ni —  o  i  1 1  to 

COMPOUNDED  MAKENA  -  LAB  RESULTS 

12/07/2012 

OKA/ 

i  imiw  r\c  dm — todi  idau 

UNIV  Or  PI  1  1  bbUHCjH 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/DMPT/nnFR/nRP/ninp/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/SW-FO/KAN- 

DO/KAN-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

O  A  H  O  O  A  A  vt 

201 2-8024 

4  J  J/IO  /OA  ■(  a 

1 1/08/2012 

rUA/OMP  1 /OdEK/UOUIJ/IJIJCJM/ 

Robert  Blaskiewicz 

a  mtim  rAni  a  o~r/™\  nio  AO  rvnmn  itkit  a  i    /~»  a  k  i  /~i  r-  r->  Turn  a  n\/ 

ANTINEOPLASTONS  AS  EXPERIMENTAL  CANCER  THERAPY 

12/07/2012 

ALFB/ 

O  wl4C 

Self 

-  APPROVALS,  WAIVERS 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  V  1  1       1  /  \m/  L- /  1       1    1/  \-S  III     /  1 — f  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8025 

1 1/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  Vw/  Lri/  1  11   1/  Vw'  Vw*  l_  1  1/  I  /  1    Vw/  1/ 

K1 20941 

l\l^  \J           1  1 

12/07/2012 

Healthlnterlink 

2012-8026 

1 1/08/2012 

1     1  /  \J\JI  L—\J\C— 

FDA/OF/CFSAN/OCD/EOS/ 

ENERGY  DRINKS  -  AERS  f01/01/2010  -  1 1/07/2012) 

12/07/2012 

Zafar  Hayat  Khan 

2012-8027 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L~/  /  V/  Vw/  1  v  1  1      1  /  \w/  L*/  1  11   1/  Vw/  W  1— —  1  1/  1  /  1    Vw/  1/ 

SOOJUNG  MOON 

w  Vw/  Vw/  O       1  *J  Vw^    1 V 1  Vw/  Vw/  1  N 

K9052S2-  K904870'  K9R3100  ETC 

12/07/2012 

ENDOTEC  INC. 

2012-8028 

1 1/08/2012 

1    1  /  W V//  LU  1  L 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          1  '  /      V/    Vw/  1  V  1   1              1     /    W   Lp/    1       11       1/    Vw/  Vw/  l_  1       1/     I  /   1         Vw/  J/ 

Rrpt  Andrp 

1 — '  1  Vw*  1   1  \  \  \  Vvl  1  V-> 

P010019 

12/07/2012 

EyeReg  Consulting,  Inc. 

2012-8029 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  Vw/  I—/  1  11   1/  Vw/  Vw/  l__  1  1/  I  /  1    Vw/  1/ 

K1 20941 

12/07/2012 

Healthlnterlink 

2012-8030 

1 1/08/2012 

1  1 1  \J \JI  t—\J\i— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          1  '  /      V/    Vw/  1  V  1   1             1     /    Vw/   Lp/    1       11       1/    Vw/  Vw/  l_  1       1/     I  /   1         Vw/  |/ 

Danna  Kphm 

I—/  CX.  1  1 1  1  CI  1  V  \w*  1  1 1  1  1 

K1 12858 

i\i  i  C—    v-/  Vw* 

12/07/2012 

Healthlnterlink 

2012-8031 

11/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Bret  Andre 

K001962 

12/07/2012 

EyeReg  Consulting,  Inc. 

2012-8032 

11/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

K072272 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

12/07/2012 

Healthlnterlink 

2012-8033 

11/08/2012 
12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Bret  Andre 

EyeReg  Consulting,  Inc. 

P980006 

2012-8034 

1 1/08/2012 
12/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \-S  IS  1  1  1/        III    /  ( — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Parkpr  Thpuninrk 

1     dl  Ivvl      III \j  Ul  III  1  Vri/l\ 

Meagher  &  Geer,  PLLP 

METOCLOPRAMIDE-CONTAINING  PRODUCTS  - 

i  v  1 1      i  \s  v_y  i  \s  i    i  \ 1  \  i  vii  \s  \   \w /  \w/ 1     i  /  v  1 1  m  1 1  x       i    ii  Vw/ i_/  Vw^  v  /  i  v_j 

NOTIFICATIONS  12/08 

2012-8035 

1 1/08/2012 

1     1  /  \J\JI  L—\J\C— 

12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    \—s  1  \!  \w/  1  v  1  1      1  /  \  '  IS  1  11   1/  Vw/ \J  l__  1  1/  1  /  1    Vw/  1/ 

Rrpt  Andrp 

IS  1  V_/  I   I  \  1  1  1 

EyeReg  Consulting,  Inc. 

P040045 

2012-8036 

1 1/08/2012 

1  \  1  \J \JI  t—\J\i— 

12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  L-/  1  11   1/  \S  \S  1—  1  1/  1 — /  1    Vw/  1/ 

Rrpt  Andrp 

IS  1  Vw*  I   / \  1  1       1  t> 

EyeReg  Consulting,  Inc. 

K1 00349 

2012-8037 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  Lh'  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

Rrpt  Andrp 

IS  1  V_/  I   / \  1  1       1  w 

EyeReg  Consulting,  Inc. 

K032390 

2012-8038 

11/08/2012 
12/07/2012 

1  C—l  \J  1  1  t—\J  1  £_ 

FDA/OMPT/CDRH/OCER/DFOI/ 

Bret  Andre 

FvpRpn  Con^i iltinn  Inr 

i —  y  t»  i  i  o  y  *skj  i  i  o  u  i  li  i  i  y .  1 1  i  o . 

K002099 

2012-8039 

11/08/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ASHER  KASSEL 

SOTERA  WIRELESS  -  K1 22036,  MONEBO  TECHNOLOGIES  - 

12/07/2012 

FDA/OC/OES/DFOI/ 
FDA/OC/OES/DFOI/ 

LIFEWATCH  TECHNOLOGIES 
LTD 

K062282 

2012-8040 

11/08/2012 
12/07/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

BOBBY  SCHOCHET 

OLSSON  FRANK  WEEDA 
TERMAN  MATZ  PC 

LTR  TO  CDRH  OR  CBER  TO  ANY  CLNCL  REGARDING  LAB 
DEVELOPED  TESTS  (LTD)  LAST  2  YRS 

2012-8041 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

12/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRANDON  L  BOGLE 

IS  1  1 1  \  1  h  IS  \s  IN    1  ■    U\y  \J  1  l_ 

LEVIN  PAPANTONIO  ET  AL 

MERCK  &  CO  -  FOSAMAX  ATYPICAL  FEMUR  FRACTURES 

i  v  1 1  i  i  > — / 1  \  lx  > — /  v_/      i  \w/  v^j  y  \  i  vi/  \  /  \  /  \  i    i  i    i  Vw/ /  \  i      i   i_  i  v  i  \s  i  i  i   i  ii  v  Vw/  i  v^y  i  1 1_ 

AERS,  CLNCL  TRIAL  DATA 

2012-8042 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\C— 

12/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \  '  IS  1  1  1/  \S  III    /  IS  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  1  1  1/  W  III    /  I — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

THOMAS  WONG 

1  1   1  \S  1  V  1 1  \  \S    V  V  \s  1  N  \—A 

DEETH  WILLIAMS  WALL  LLP 

FDA  APRVD  DRUG  PRODUCTS'  WITH  THERAPEUTIC 

1     IS  1  \  1  \  1     1  l  V  IS    \S  1  1  KJ          1     1  I  Vw/  1  /  ' — J  > — /  1        .    V  V  1  1  1   1     III  1— —  1  I  /  V 1     l_  \S  1  1  \S 

EQUIVALENCE  EVALUATIONS  16TH  EDITION  (1996); 
CUMULATIVE  SUPPLEMENT  1/96  TO  7/96 

2012-8043 

1 1/08/2012 
12/07/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DONALD  N.  BLUE 
ZETETIC  INC 

ENTRY  NO  AV3-00379904 

2012-8044 

11/08/2012 

FDA/OC/OES/DFOI/ 

JOHNSON  &  JOHNSON/JANSSEN  PHARMA  -  RESPERDAL 

12/07/2012 

FDA/OC/OES/DFOI/ 

BROWN  219191,  KENYA 

(RESPIDOL)  AER 

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Total  Records:  9990 


V_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  ricLjUtJoLci 

OUUJtfOl 

FDA/OMPT/GDFR/ORP/DIDP/ 

1    1  •  1  \i  V_/ 1 V  1 1      11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8045 

11/08/2012 

FDA/OMPT/CBER/OCOD/DDOIW 

BRETT  PARK 

VAERS  -  INDIVIDUAL  RECS 

12/07/2012 

ALFB/ 

CONWAY,  HOMER  &  CHIN- 
CAPLAN  PC 

2012-8046 

1 1/08/2012 

i  \  1  \J \JI  t—\j\i— 

12/07/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

DAILY  LOG  10/15-19/12 

lw/  /  V 1  L_  1     \  V_/           1  \J  1    1  xj     \  \Jl    1  I— 

2012-8047 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

12/07/2012 

FDA/OC/OES/DFOI/ 

1  1— •  i\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

DAILY  LOG  10/22-26/12 

2012-8048 

1 1/08/2012 

1  1  /  \J \JI  t—\J\i— 

12/07/2012 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

DAILY  LOG  10/8-12/12 

L-/  /  VI  1       1     1  V/  V^     1  \Jl  \J     1  ^/    1  C— 

2012-8049 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

DAILY  LOG  9/17-21/12 

2012-8050 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  10/8-12/12 

2012-8051 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  10/22-26/12 

2012-8052 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  10/15-19/12 

2012-8053 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  9/17-21/12 

2012-8054 

fc-W  1  i—    V/  v/  **/  I 

1 1/08/2012 

1     1  /  \J\Jl  L—\J\l— 

12/07/2012 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCRAMP 

L_  1  \  )  I  \      1  /   V  1   1  1   1  1  v_/  Vw/  1  V     V/  Vw/  1    I  /  \  1  V  1  1 

CanReg,  Inc. 

DAILY  LOG  10/22-26/12 

l_/  /  V  1  L_  1      LV/\J     1  \J  1  L—  C—    L—  V//    1  L— 

2012-8055 

1 1/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V_/ 1  \     1  /  \  III  11       V_/  1  N         Vw/  1   1  1  I  /  \  1  V 1  1 

CanReg,  Inc. 

DAILY  LOG  10/15-19/12 

1  /  /  VII—  1     l  V_/           1  V//    1  v/     1  \Jl    1  L_ 

2012-8056 

t —  V_/    1  L —  V/V/V/V/ 

1 1/08/2012 

1     1  /  v/  \Jf  L —  \J   1  C — 

12/07/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

DAILY  LOG  10/8-12/12 

2012-8057 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

DAILY  LOG  9/24-28/12 

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Total  Records:  9990 


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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8058 

1 1/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  10/8-12/12 

L/ 1  \  \  L       1     1  V/VJ     1  \Jl  \J     1  C—l    A  C— 

2012-8059 

1 1/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

1  1    \  \J  1    l  l_  1  V|     Vw/  ■     1  '  i    \  i    1 1  i 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  10/15-19/12 

2012-8060 

1 1/08/2012 

1     1  /  \J\Jl  L—\J   I  L— 

12/07/2012 

FDA/OC/OES/DFOI/ 

DAVID  McFARLAND 

FDA  WEBVIEW/FERDIC  INC 

DAILY  LOG  10/22-26/12 

2012-8061 

1 1/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

1    1— Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  McFARLAND 

i  j  i  \  v  1 1  /  iviui  /  v  i  1 1_/  v  i  >i  \ — / 

FDA  WEBVIEW/FERDIC  INC 

DAILY  LOG  10/8-12/12 

2012-8062 

1 1/08/2012 

1     1  /  \J\J/  L—\J   I  L— 

\2I07I2Q\2 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  McFARLAND 

FDA  WEBVIEW/FERDIC  INC 

DAILY  LOG  10/15-19/12 

2012-8063 

1 1/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

BARBARA  JONES 

1  J  /  \  1  1 1  /  /  \  1  l  / \  U  Vw/  1  *J  1  \_) 

DOMINION  GROUP  INC 

DAILY  LOG  9/24-28/12 

l_/  /  VI  l_  1     \  v^/  V_-4    \J  1  C—\     C—  V//    1  L  

2012-8064 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

WILLIAM  A.  OLSON 

Center  for  Regulatory  Services, Inc. 

DAILY  LOG  9/24-28/12 

2012-8065 

11/08/2012 
12/07/2012 

FDA/OC/OES/DFOI/ 

KENNETH  REID 

WASHINGTON  INFORMATION 
SOURCE 

DAILY  LOG  9/17-21/12 

2012-8066 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Michaela  Laussegger 
Austrian  Trade  Commission 

AUSTRALIAN  TRADE  COMMISSION  -  LIST  OF 
ESTABLISHMENTS  USING  AS  US  AGENT  FOR 
BIOTERRORISM  FOOD  REGISTRATION 

2012-8067 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 

INDIVIDUAL  RECS 

2012-8068 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 
LaVeeta  Moten 

CFSAN  BUDGET  EXECUTION  AND  ANALYSIS  &  REPORTING 
TEAM  MEMBERS  -  NAMES,  DUTIES,  PROJECT  TIMELINES, 
ETC  (10/01/2009  -  11/08/2012) 

2012-8069 

11/09/2012 
12/10/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Glenn  Irish 

Glenn  Irish  Consulting 

SHIRE,  LEXINGTON,  MA  -  483  (11/01/2011  -  11/08/2012) 

2012-8070 

11/09/2012 
12/10/2012 

ORA/ 
ORA/ 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/0GR0P/0RA/PA-F0/L0S- 
DO/LOS-CB/ 

FDA/0GR0P/0RA/SE-F0/N0L- 

Kimberly  Kindy 

THE  WASHINGTON  POST 

CENTRAL  ADMIXTURE  PHARMACY  INC,  APOTHECURE, 
PHARMEDIUM  SERVICES  -  INSPECTION  RECS 

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Total  Records:  9990 


Control  # 

Reed  Date  / 

UUc  LJdLc 

Action  Office 

Signature/  Requester 

Subject 

DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-GB/ 

F  D  A/OG  ROP/O  RA/S  W-  FO/KAN- 
DO/KAN-CB/ 

ORA/ 

ORA/ 

2012-8071 

11/09/2012 
12/10/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

AMRI 

BAXTER,  MARION,  NC  -  EIR  MOST  RECENT 

2012-8072 

11/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

INDIVIDUAL  RECS 

12/10/2012 

FDA/OO/ 
FDA/OO/OHR/ 

1          1  /  1      \l    Vw/  Vw//    Vw/  1111/ 

Doe  J 

2012-8073 

11/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CORR  RE  GS-1 4  TRAVEL  LEAD  POSITION  WITHIN  CFSAN 

12/10/2012 

FDA/OO/ 
FDA/OO/OHR/ 

1    ]  /  /  V/  Vw/  Vw/ /  Vw/  1111/ 

LaVeeta  Moten 

2012-8074 

11/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

OFFICE  OF  MANAGEMENT  SYSTEMS  -  TRAINING  RECS 

12/10/2012 

FDA/OO/ 
FDA/OO/OHR/ 

1  1 — '  /  V/  Vw/  Vw//  Vw/  1111/ 

LaVeeta  Moten 

2012-8075 

11/09/2012 
12/10/2012 

ORA/ 
ORA/ 

FDA/OC/OES/DFOI/ 

Kimberly  Kindy 

THE  WASHINGTON  POST 

CENTRAL  ADMIXTURE  PHARMACY  SERVICES, 
PHARMEDIUM,  APOTHECURE  -  INSPECTION  RECS 

2012-8076 

1 1/09/2012 

1  1 1  \J \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  t — '  1  ]  /  1  / 

in^pnh  h^rton 

ORANGE  BOOK  -  CORTICOTROPIN 

Vw/  1  1 1  \  1  M  Vw4  1— —  I— J  Vw/  Vw/  1  \  Vw /  V-/  1  1  1  1  V-/  V- /  1  1  1 V-/  1     1  1  *J 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

joseph  barton 

2012-8077 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
L.P. 

MONSTER  ENERGY  DRINKS  -  AERS 

2012-8078 

11/09/2012 
12/10/2012 

OM/OMP/DODM/ 

Carrie  Kahn 
CHEMRISK  LLC 

DKT  1975N-0190  -  COMMENTS  SUBMITTED  BY  THE 
SOCIETY  OF  THE  PLASTICS  INDUSTRY  RE  VINYL 
CHLORIDE  EXPOSURE  FROM  CUTTING  PVC  PLASTIC  FILM 

2012-8079 

1 1/09/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

fipnnn^nn  Park 

NDA  019594 

1  ML//  V   \J  1  \J\J\J^T 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DAEWOONG  AMERICA  INC 

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Total  Records:  9990 


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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8080 

1 1/09/2012 

1    1  /  V/  C/  £_U  1 

12/10/2012 

ORA/ORM/ 

\_/ 1  l / v  Vw/  1  11 VI/ 

ORA/ORM/ 

JOHNATHAN  RICKMAN 

\J  V_/  1   IIM/^  1  1   mi  M    1  1 1  \_/ I \l  Vl/^l  N 

FDA  NEWS 

PHARMACEUTICAL  BIOLOGICS  MEDICAL  DVC  MFG 

1     1   1 1  \  1  1 1 V 1 1  \ Vw/  1  \J  1   1  V/ 1  \  1  ,    l—)  1  Vw/  1  Vw/ \Jt  1  V/  vJ  .    1  VI 1  l_/  1  \w/ / \ I       !_/  V  Vw/    1 VI 1 

FACILITIES,  ETC -483S  10/1-31/12 

2012-8081 

1 1/09/2012 

1    1  /  W  C/  £_  VJ  1 

12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

FRANK  E  PISOITELLI  JR 

i  i  irvi  "Ji  \  i      i   i Vw/ Vw/ 1  i  i  i  i  i  \j\  \ 

PISCITELLI  LAW  FIRM 

\A/uijc  WAVE  FOODS  CO  BROOMFIELD  CO  -  HORIZON 

V  V  1   1 1  1  1        II 1  \  V  1        1    \_/v_/  1  '  w   Vw/  Vw/  5    LJ  I  1  Vw/  Vw/  I VI 1     II  1  L/  .    Vw/  Vw/        I   1  Vw/  I  1 1  Z_  V_/  1  N 

ORGANIC  MILK  PRODS  INVESTIGATIVE  RECS 

2012-8082 

1 1/09/2012 

1    1  /  W  C/  £_U  1 

12/10/2012 

FDA/OF/CFSAN/OOD/EOS/ 

LaVeeta  Moten 

IMPAC  TRAINING  SESSION  -  PRESENTERS  TRAINING 

IIVII    l  \  V/     1  1  l/\  1  1  M  1  1  N  Vwi    \J\  Vj<JI\/l  M         1     1  11  vJ  1  IN  1  1  1  1  v. > .     1  1  lr\l  1  N  II  >l  VJ 

MATERIALS 

2012-8083 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 

OFF  ICE  OF  MANAGEMENT  SYSTEMS  -  REPLACEMENT 

FOR  DETAILS 
■  >  '  1 1  I—*  i  1 1 \  1 1  >  ' 

2012-8084 

1 1/09/2012 
12/10/2012 

CVM/OCD/ 

A\/IM  AOI  1   |/A  n 

AVINASH  KAR 

NATURAL  RESOURCES 
DEFENSE  COUNCIL 

l—/  l__  1    l_  1  N  \J  l__    V/  Vw/  V/  1  M  V_/  1  l_ 

\  ir\\  i  ^/ir~  t~\  I —  AMTiniATi^p  I  lorn  ammi  iai  i  \/  i  iv  I  i — r~\r~\  r^i 

VOLUME  OF  ANTIBIOTICS  USED  ANNUALLY  IN  FOOD- 
PRODUCING  ANIMALS  -  RECS  2000  TO  PRESENT 

2012-8085 

11/09/2012 

FDA/OF/CFSAN/OCD/EOS/ 

EDUCATION  AND  EXPERIENCE  RECS  -  GOVERNMENT 

12/10/2012 

1      /   1  V//  £_U  1  £_ 

FDA/OO/ 
FDA/00/OHR/ 

BUDGET 

2012-8086 

11/09/2012 
12/10/2012 

ORA/ 
ORA/ 

JUSTIN  BROWNE  ESQ 
JANET,  JENNER  &  SUGGS,  LLC 

NEW  ENGLAND  COMPOUNDING  CENTER  -  EIRS,  483S, 
TESTING  RECS,  ETC  10/26/12 

2012-8087 

L—\J  1  £_    <JU(J  / 

1 1/09/2012 

1    1  /  V/  C/  £_U  1  I— 

12/10/2012 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  Vw/  III    /  L/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  l—s  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

LOU  OAPUTO 

i  v_/  v/  v/ni   kw/  i  Vw/ 

EMORD  &  ASSOCIATES,  P.C. 

BLIS  TECHNOLOGIES  LTD  -  BLIS  K-12  TRAVEL  GUARD 

LJ  I  1  w     1  1  Vw/  1   1 1  N  Vw/ 1  Vw/  V^  1 1  \J    I      I  L/        LJ  1  1  vJ    1  \     1  L—     II  1 1  \  VI  1       VJ  VJ  IX  \  1  LJ 

IMPORT  REFUSAL  NOTICE  OF  DETENTION  &  HEARING 

2012-8088 

11/09/2012 
12/10/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

SHUGART,  ROBERT  M 

REGENERATIVE  TECHNOLOGIES  INC  -  EIR, WARNING  LTR 
10/12 

2012-8089 

11/09/2012 
12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

BECKY  COOSEMAN 
BROWN  &  CROUPPEN  PC 

CRONOBACTER  SAKAZAKII/CRONOBACTER 
SP/ENTEROBACTER  SAKAZAKII  -  CORR,  TESTING  RECS, 
DENDROGRAMS,  ETC;  INDIVIDUAL  RECS 

2012-8090 

1 1/09/2012 

1    1  /  V/ LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  V/  l_/  1  1  1/  V_/  III    /  L/  1  1  /  1  / 

BRANDON  L  BOGLE 

1  '  1  I 1  \  1  N  L/  V-/  1  N    1       1  }  Vw/  V_^1  t  1  

MERCK  &  CO  INC  -  FOSAMAX  (ALENDRONATE  SODIUMS 

1 V  1  1  1  1 V-/  1  \  VA    \J  Vw /    1  1  >l  V-/        1    Vw/  V_/ 1  \  \  VI/  \/\    \  1  \  1—  1—  1  N  LJ  1  I  Vw /  1  M I  \  \  l_   \J  Vw/  LJ  1  Vw/  1  V 1  1 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

LEVIN  PAPANTONIO  THOMAS  ET 
AL 

AERS,  CLNCL  RECS 

2012-8091 

11/09/2012 
12/10/2012 

FDA/OC/OES/DFOI/ 

COLLEEN  K  DUCAS 
SANOFI  PASTEUR 

2012-6926 

2012-8092 

11/09/2012 

FDA/OGROP/ORA/CE-FO/DET- 

MICHAEL  CSKOUTERIS 

HILL-ROM  COMPANY  CORP,  BATESVILLE,  IN  -  DEFECTIVE 

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FDA/OMPT/CDRH/OCER/DFOI/ 

SKOUTERIS  &  MAGEE  PLLC 

HOSPITAL  BEDS  INVESTIGATION  RECS,  RECALL, 
WARNINGS,  ETC 

2012-8093 

1 1/09/2012 
12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    !  '  1  \i  Vw/ 1 V  1  1      11  \J  1— •*  1  1  1/  V_/  III    /  l_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

NURIA  MARCOS  OLIVAN 

GLENMARK  PHARMACEUTICALS 
MEXICO  SA  DE  CV 

AARTI  INDUSTRIES  LTD  THANE  INDIA'  SYMBIOTEC 

1  \l  \  1  1  1  1    1 1  M  L/  W  w  1  1  1 1  1  \J    1      1  1  •' ,     III  1  \  INI  ,    1 1  M  1— /  1  /  V  ,    \J  1  1  V 1 1  1 1  V_/  1  1  \J 

PHARMALAB  LTD,  INDORE,  INDIA;  MATRIX  LABORATORIES 
LTD,  SECUNDERABAD,  INDIA  -  EIRS,  483S 

2012-8094 

1 1/09/2012 

ORA/ 

ANDREW  KAHN 

1  \  \  il  lw/  1  1 1_  V  V    1  \l  \  1   1  1  *l 

ST  JUDE  MEDICAL  INC  SYLMAR  CA  -  483  10/1 2 

\j  i    kj     \—J  i      i  vi  i  i_/ 1  v/ 1  \ i      1 1  n  \j .  \j  i  i  i  v  ini  i ,  v/ 1  \                 i  V//  i  C— 

12/10/2012 

ORA/ 

DAVIS  COWELL  &  BOWE  LLP 

2012-8095 

11/09/2012 
12/10/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

DOUGLAS  N  BLUE  II 
ZETETIC  INC 

SIMILAC,  ENFAMIL  INFANT  FORMULA  ENTRY  #DP406043860 
-  RECS 

2012-8096 

11/09/2012 
12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

HELEN  LEWIS 

DENTSPLY  INTERNATIONAL, 
INC. 

3M  -  ESPE  LAVA  CHAIRSIDE  ORAL  SCANNER  K073199 

2012-8097 

1 1/09/2012 
12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  II — 1  1 — hi    1  1 — VA/IO 

HELEN  LEWIS 

DENTSPLY  INTERNATIONAL, 
INC. 

n>  1        |   |M  IT-! —  IX    I     A  \  /  A     /"«  1   1  A  1  n  O  I  1 —    /-\  n  A  1           /~i  A  MMI —  n                 ^  l~\f>  A 

3M  -  UNITEK  LAVA  CHAIRSIDE  ORAL  SCANNER  K081961 

2012-8098 

1 1/09/2012 

1     1  /  \J  sJI  t—\J\l— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \-S  \S  \  11   1/  \-s  \S  1— —  1  1/  1 — /  1    Vw/  1/ 

LIMIN  ZHENG 

l_  1  1  V 1  1  1  M    L  1   1  1  1  *J  V/ 

VYSIS  -  UROZYSION  BLADDER  CANCER  RECURRENCE  KIT 

V    1  Vw/  1  Vw/        V/  1  l  Vw/  £      |  Vw/  1  Vw/  1  VI    I  >  \  /  V 1 — /  L/  1  1   1   V/  V  \  1  v|  \_J  \  1  l    1  1 1_  V/  V*/  1  1 1  1 1  1  v|  V/  I        1  \  1  1 

12/10/2012 

FDA/OC/OES/DFOI/ 

FISH  &  RICHARDSON  PC 

K011031 

2012-8099 

11/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

LIMIN  ZHENG 

ABBOTT  MOLECULAR  -  UROVYSION  BLADDER  CANCER  KIT 

12/10/2012 

FISH  &  RICHARDSON  PC 

P030052 

2012-8100 

11/09/2012 
12/10/2012 

OM/OMP/DODM/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  ( — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JULIE  NAUD 

GROUPE  BNA  CONSULTANT 

\-A  1     1  Vw/  Vw/  1        1             l  I  1   >|  1    \      V/  Vw/  1    N  O  Vw/  1          |    /     VI    N  | 

GROUP 

BIOLOGICAL  TESTING  PROCEDURES  FOR  FLUORIDE 
DENTIFRICES  -  DKT  1980N-0042 

2012-8101 

1 1/09/2012 
12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  t — /  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CANDICE  DURRENCE 

\  '  1  \  \  *l  L/  1  Vw/  1       l/  v^y  1  1 1  1 1  1  V  Vw/  1  

OPTIMER  PHARMACEUTICALS 
INC 

OPTIMER  PHARMACEUTICALS  INC  -  DIFID  (FIDAXOMICIN 

Vw/  1      1  1  1  v  1  1  III     II 1  V 1  1 1 V  1 1  \ V_/  1  Vw/  1  1  vr\LU    1  1  *  Vw/        L/  1  1     1  l_/    11    1  1—/ /  \ /  V  Vw/  1  VII  V/  1  1  i| 

TABS)  NDA  201-699  AERS  4/27/12-1 1/7/12 

2012-8102 

11/09/2012 
12/10/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

DONNIE  ALLEN  SNOW 
SKOUTERIS  &  MAGEE  PLLC 

HILL-ROM  COMPANY  CORP,  BATESVILLE,  IN  -  EIRS,  483S, 
MDRS,  ETC 

FDA/OMPT/CDRH/OCER/DFOI/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 


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Control  # 

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2012-810'? 

1 1/09/2012 
12/10/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

HANIF  SACHEDEDINA 

1   l/\l  N  1  1      V  '  1  \  \J  1   II  L/  1  1  '  1  1  N  i\ 

CIPHER  PHARMACEUTICALS  INC 

AIDERAX  PHARMACEUTICALS  INC  CORONA  OA  -  EIRS 

niL/i  i             i    i  1 1  \ \  iivinwi  \j  i  ivjrxLvj  m           v_/v_/i  iviNn,  \w/ / v      i  ii  iu, 

483S  MOST  RECENT 

2012-8104 

1 1/09/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ROBB  PERRY 

1  I       \—)  \— J  1    1  1  11  1  1 

COMBAT  MEDICAL  SYSTEMS  LLC  -  COMBAT  READY  CLAMP 

V—/ 1  v  1 1  •  i  \  i    ivii  uiwnL  \j  i  vJ  i  i  ivivj  i  i  \s          Vw/ 1  v  i       \  i    i  ii  /  1 1  >  i    v_/ 1  n  i  v  1 1 

12/10/2012 

NORTH  AMERICAN  RESCUE  LLC 

K1 02025 

2012-8105 

11/09/2012 
12/10/2012 

FDA/OC/OES/DFOI/ 

ROBERT  P  CHARROW 
GREENBERG  TRAURIG  LLP 

2006-15538,  2006-15634,  2012-3772 

2012-8106 

L—\J    1  C—    \J   1  \J\J 

1 1/13/2012 

1     1  /    1  \JI  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — /  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

ORTAV  YEHLJDAI 

\>  1  1  1  1  \  V      II  II  KJ  1— / 1  \  \ 

SYNCO  BIO  PARTNERS  BV  AMSTERDAM  NETHERLANDS  - 

w  1  1  N  V_/  V_/  \— J  1  Vw/   1    n  1  11  INI  1  IvJ   1  /  V  .  i\  \  V  1  w  II  1  l  1— /  7  \  1 V 1 ,    1  M  1       II  II  1  1 1  1  \  \  N  1  '  \-J 

12/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

GREAT  POINT  PARTNERS  LLC 

483S  1/12  TO  PRESENT 

2012-8107 

1 1/13/2012 

1  1  /  1  \JI  t—\J\i— 

12/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V^/  III    /  \ — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ORTSV  YEHUDAI 

1    1   1           V       1    1  1    1        IS  1  V 1 

GREAT  POINT  PARTNERS  LLC 

BOEHRINGER  INGELHEIM  AUSTRIA  GMBH  VIENNA 

1  '  \S  1  1   II  111  N        1  11    1  1  V  \J  1  1  1   1  1  1  1  V 1   1  V  V  '        1  1  1 1 V  \         1 V  1  1  }  11^     VI  1  INI  N/  \  j 

AUSTRIA  -  483S  1/12  TO  PRESENT 

2012-8108 

L—\J    1  C—    \J   1  \J\J 

1 1/13/2012 

1     1  /    1  \JI  t—\J\l— 

12/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

JAY  H  HENDERSON 

\J  1  \  1     1   1    1   1 1_  1  N  J  /  l__  1  1 '  Vw/  1  N 

JAY  HENDERSON  PLLC 

PARKE  DAVIS  -  CEREBYX  (FOSPHENYTOIN1  NDA  20-450 

1     /  \  1  1 1  \  1   1 — '  1  \  V  1  Vw/        V-/  l_  1  1 1_  1  }  1  /  \    11  V- /  V— '  1     1   1  l_  INI     1  Vw/  1  1  N  J      IN  1— /  V  \  £_  W    ^  v_/ 

LBLG  OR  LBLG  CHANGES  1/1/07  TO  1 1/1/12 

2012-8109 

11/13/2012 
12/11/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

ORTAV  YEHUDIA 

GREAT  POINT  PARTNERS  LLC 

APTUIT  LLC,  KANSAS  CITY,  MO;  HARRISONVILLE,  MO  - 
483S  1/12  TO  PRESENT 

2012-8110 

11/13/2012 
12/11/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

ADAM  DIEDERICH 
SCHIFF  HARDIN  LLP 

KEATON  WALKER,  TRANSPORTATION  LLC  -  SLAUGHTER 
OF  HORSES  CORR,  LICENSES,  PERMITS,  ETC  1/11  TO 
PRESENT 

2012-8111 

11/13/2012 
12/11/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

KYLA  BERNNETT 

PUBLIC  EMPLOYEES  FOR 

ENVIRONMENTAL 

RESPONSIBILITY 

EASTERN  EQINE  ENCEPHALITIS  VACCINE  -  RPTS,  IND, 
SS&E,  ETC 

2012-8112 

11/13/2012 
12/11/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CARLA  R  SCARMAZZI 
KING  &  SPALDING 

HUMAN  EXPOSURE  TO  CAFFEINE  -  RESP  LTR  8/10/12 

2012-8113 

11/13/2012 

ORA/ 

CDER  OR  CDRH  FOREIGN  INSP  RECS 

01/09/2013 

ORA/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

ORA/ 

ORA/ 

SCHRIFLER,  JEFF 

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Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

2012-8114 

11/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ELIZBETH  RICHARDS 

EXCLUSIVE  SUPPLEMENTS  -  BIORHYTHM  SSIN  JUICE; 

12/11/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

LATHAM  &  WATKINS  LLP 

FAHRENHEIT  NUTRITION  -  LEAN  EFX'  GASPARI  NUTRITION 

1    t  \  1   1  1  1 1  Ivl   1  1  II     IN         1  1  1 1  1  1  Vw/  1  i|        L_  1_  1  \  1  M    1  1    /\  ^         1  \  V/  1    1  \  III    1  Nl  V/  1  1  1 1  1  1  V/  1  N 

-  SPIRODEX,  ETC  RESP  TO  WARNING  LTRS  4/24/12 

2012-81 15 

1 1/13/2012 

1    1  /  1  \JI  t—\J\l— 

FDA/OC/OES/DFOI/ 

LIST  OF  RECS  REQUESTED  BY  PEOPLE  FOR  THE  ETHICAL 

i  i  u  i         i     i  1 1  Vw/ i  1 1  vx ■ — J  \—  Vw/  i  i  (  /  i  j  i    i    i  \w/ 1    i  i      i   Vw/  ii    ill  i       i_  i  i  1 1  ur\L 

1  C-l    1     1  /  £_U   1  C- 

Dl  lOHNF^KIF  ^TFPHANIF 

TREATMENT  OF  ANIMALS  (PETA)  9/1/12  TO  10/1/12 

2012-8116 

11/13/2012 

ORA/ORM/ 

TYLR  KENYON 

LIST  OF  EIRS,  483S  -  LAST  SIX  MONTHS 

12/11/2012 

ORA/ORM/ 

NORTHCOAST  RESEARCH 

2012-8117 

11/14/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 

ALTRIA  CLIENT  SERVICES,  PHILIP  MORRIS  USA  INC, 

12/12/2012 

FOI  Services,  Inc. 

SMOKELESS  TOBACCO  COMPANY  LLC  -  LIST  OF 
PRODUCTS  NOTIFIED  FDA 

2012-8118 

11/14/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 

ALTRIA  CLIENT  SERVICES,  PHILIP  MORRIS  USA  INC, 

12/12/2012 

FOI  Services,  Inc. 

SMOKELESS  TOBACCO  COMPANY  LLC  -  PRODUCT 
LISTING 

1  1        1  1  1  il  Vwl 

2012-8119 

11/14/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 

QUARTERLY  CTP  USER  FEES  10/01/11  TO  PRESENT 

12/12/2012 

OC/OM/OFM/ 
FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-8120 

1 1/14/2012 

FDA/OMPT/CTP/OD/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  1  1    /  Vw/  L/  / 

Rpphpl  .lohn^on 

1  IQl^l   CI  JU    II  IOUI  1 

OTP  USER  FEES  SINCE  10/01/1 1 

W  1  1       V/  \J  1  III     1  1  vj    \-s  1 1  N  V/  1         1  \JI  \J  1  1   I  1 

12/12/2012 

OC/OM/OFM/ 

V_/\_//  V^"  1 V 1/ \_/ 1  Ivl/ 

FDA/OC/OES/DFOI/ 
FDA/OC/OES/DFOI/ 

FOI  f^prvippQ  Inr 

2012-8121 

1 1/14/2012 

FDA/OMPT/CTP/OD/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  1  1    /  Vw/  1 — J I 

Rophpi  .Inhn^on 

1  IQUI  lul   l_/  KJ  1  II  IOUI  1 

CTP  USER  FEES  -  MANUFACTURERS  AND  IMPORTERS 

w  i  i     \j  \—)  i— _  i  i  i   i  i  v/      i  v  1 1  \  i  *i  v/ 1  r\w  i  \—/ 1  1 1  i  i  v/  /  v  i  m  ]  /  1 1  v  1 1   w  ill  i— _  i  i  \-j 

12/12/2012 

OC/OM/OFM/ 

FDA/OC/OES/DFOI/ 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

ASSESSED  10/01/11  TO  PRESENT 

2012-8122 

1 1/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  1 — '  1  l_/  1  / 

Christine  Phillinq  PhD  RAC 

V/  1  II  1 0  LI  1  1  O    1     1  1 1 1 1 1  k/ O  ^    1     II  L/  j    1  1 1  \  V/ 

BLA  1 25276  S49 

I  *  1  1  \     1  L—  v/  C—  1  \J   V/  1^  v/ 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2012-8123 

11/14/2012 
12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
LP. 

MONSTER  ENERGY  -  AERS 

2012-8124 

1 1/14/2012 
12/12/2012 

CVM/OCD/ 

Marv  Schwanpr 

i  v  i i  y   Uui  i  vw        v  i 

News  Pro  Net  TV 

PET  MEDICATIONS  ERRORS  -  LAST  THREE  YEARS 

2012-8125 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

RON  BELLDEGRUN 

NDA  02161 0  -  ABUK  IMPURITY 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

belldegrun,  ron 

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FDA/OMPT/CDER/ORP/DIDP/ 

2012-8126 

1 1/14/2012 

1     1  /     1      It  L—  \J    1  L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  V_/  III    /  t — '  1  L-/  1  / 

Christine  Phillinq  PhD  RAC 

V/  1  1  1  1  O  L  1  1  1  \J    1     1  1  1  1  1  1  L/O  >,    1     II  J  /  .    1  \  1  \  Vw/ 

NDA  203214 

1  M  1 — '  1  \  C—  \J     L—  1  i 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L*/  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Eli  Lilly  and  Company,  Inc. 

2012-8127 

11/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ryan  Gregerson 
American  Sleep  Association 

K963591 

2012-8128 

11/14/2012 
12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
L.P. 

RED  BULL- AERS 

2012-8129 

1 1/14/2012 
12/12/2012 

FDA/OF/GFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
L.P. 

ROGKSTAR  ENERGY  PRODUCTS  -  AERS 

2012-8130 

fc-V/  1  £_    V/  1 

1 1/14/2012 

1    1  /   1  TV  £—  V/  1  £— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

CiPoffrpv  Rnhprt  Ohamhpr^ 

VJIjU  \\l  \j  y    1  IUUUI  I    \J  1  lul  1  1  k/ V/  1  O 

VASCEPA  EXCLUSIVITY  DETERMINATION  LETTER 

V  /  V  V/  Vw/  1  1     /  V   1_  /  V  V/  1  V/  V/  1  V  1  1     1      L/  1       1  1  1  1 1  V  1  1  1  *l  i  \  1   1  Vw/  1  \    1  1       1    1  1  1  I 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Geoffrey  R  Chambers 

2012-8131 

11/14/2012 
12/12/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

VISIUM  FUNDS 

IMMUCOR  -  NOTICE  OF  INTENT  TO  REVOKE;  INSPECTION 
RECS 

^01  d--o\  od. 

11/1 4/<;01  <; 
12/12/2012 

rUA/U(jKOr/UKA/St-r(J/rLA- 
DO/FLA-CB/ 

FDA/OC/OES/DFOI/ 

CARDINAL  HEALTH 

ANAZAOHtAL  1  H  CUKH,  lAMrA,  rL  -  48o  (1<;/1/<i00y - 
12/23/2009) 

2012-8133 

L—\J    1  C—    \J   1  V/V/ 

1 1/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  V_/  III    /  ( — '  1  J  /  1  / 

Karpn  Anplln 

1  \Cl  1  \J  1  1    1  \  1  1      1  1  \J 

OXYCONTIN  -  AERS 

Vw/  /  V  1  Vw/  Vw /  1  >l  1  1  1  N        /  V  l_  1  I U 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DILWORTH  PAXSON  LLP 

2012-8134 

1 1/14/2012 

1     1  /     1  TV  t_  W    1  L— 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  l — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

.lop  Rraido 

EdgeOne  Medical  Inc 

ABCO  DEALERS  INC  -  GUAGE  SPONGE  X-RAY 

/  V  l— J  V/  Vw/    L/  1  /  \  1  L  1  I  \—J  ^    1  1  N  Vw/        V_/  V/             1        v/  1     V/  1  >l  V_/  1        /  V    1  1 1  \  1 

DETECTABLE  X-RAY  510(K)  NOTIFICATION 

2012-8135 

1 1/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

.lop  Braido 

EdgeOne  Medical  Inc 

K071519 

2012-8136 

11/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Joe  Braido 

EdgeOne  Medical  Inc 

K821150 

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2012-8137 

1 1/14/2012 

1    1  /   1  TV  LU  1  L 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

UC-Care 

K120187 

2012-8138 

L—\J    1  L—    \J   1  \J\J 

1 1/14/2012 

1    1  /   1  T/  t_  W  1  L_ 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

.lop  Rraido 

EdgeOne  Medical  Inc 

K082703 

2012-8139 

1 1/14/2012 

1    1  /  1  T/  £—  W  1  C— 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

.lop  Rraidn 

EdgeOne  Medical  Inc 

K1 03641 

1  x  1  x/v-Jx*/T  1 

2012-8140 

1 1/14/2012 

1    1  /   1  TV  t_       1  L— 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

.lop  Rraido 

EdgeOne  Medical  Inc 

K1 03641 

l\l  \J  V— '  v—'  T^  1 

2012-8141 

1 1/14/2012 

1    1  /   1  T/  £—  W  1  L_ 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

UC-Care 

K1 22329 

l\l  L—  L—  \J  L—  \J 

2012-8142 

11/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

UC-Care 

K081093 

2012-8143 

1 1/14/2012 

1    1  /   1  TV  £—  W  1  l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

Dr  Mprridpp  Wnutpr^ 

IS  1  ■    1  V 1  \j  1  1  1  \-A  \J  w    V  V  \J  UlUI  O 

APPROVED  DRUGS  -  LISTING 

/  \  1     1     1  l  Xw/  V  1— —  IS    IS  1  I  \S       O        1  1  \S  1  1 1  i| 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  1— '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Deakin  University 

2012-8144 

11/14/2012 

ORA/OE/ 

Oliver  Yu 

INSPECTION  SPREADSHEET  -  UPDATE  03/30/2012  - 

12/12/2012 

ORA/OE/ 

Zymergi  LLC 

11/06/2012 

2012-8145 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Stephen  Teti 

VIROPHARMA  -  CORR  RE  CITIZENS  PETITIONS 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  V  '  \S  1  1  1/  W  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
OM/OMP/DODM/ 

Srott+Srott  LLP 

VJuULlTUwLl]  1 — 1 — 1 

201  2-81 46 

11/1 4/201 2 
12/12/2012 

rUA/UMr  1  /CUKH/OCtK/DrUI/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

K950034 

2012-8147 

11/14/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Angelia  Slayton 

PATRICIA  MURPHY  -  483,  EIR,  CORR 

12/12/2012 

DO/NWE-CB/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-8148 

1 1/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

K880047 

2012-8149 

11/14/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Angelia  Slayton 

DARIN  S  WIEGERS  -  EIR,  483,  CORR 

12/12/2012 

DO/NWE-CB/ 

INC  RESEARCH  CONSULTING  & 

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SUBMISSIONS 

2012-8150 

11/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Veronica  Vogt 

ENBREL  -  COMPLAINTS,  AERS,  WARNINGS  ETC 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Vogt,  Veronica 

2012-8151 

11/14/2012 
12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Elisa  D.  Harvey,  DVM,  PhD 

CardioMed  Device  Consultants, 
LLC 

K121083 

2012-8152 

11/14/2012 
12/12/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

Paula  A.  Berezansky 
Diamond  Pharmacy  Services 

SHAMROCK  MEDICAL  SOLUTIONS  GROUP  LLC  - 
INSPECTIONS,  VIOLATIONS,  WARNING  LETTER  RECS,  ETC 

2012-8153 

11/14/2012 

CVM/OCD/ 

Aeree  Lee 

ZHEJIANG  JINHUA  CONBA  BIOPHARM  CO  -  EIR  (03/15/2010 

Stason  Pharmaceuticals,  Inc. 

-  03/19/2010) 

2012-8154 

11/14/2012 
12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Rachel  Johnson 
FOI  Services,  Inc. 

ABBOTT  LIQUID  PROTEIN  FORTIFIER  -  PREMARKET 
NOTIFICATIONS,  CORR 

2012-8155 

11/14/2012 
12/12/2012 

FDA/OO/OFBA/OAGS/ 

Linda  Ulrich  -  FDA 
Linda.Ulrich@fda.hhs.gov 

CHILDREN'S  NATIONAL  MEDICAL 
CENTER 

PEDIATRIC  DEVICE  CONSORTIA  GRANT  -  SUCCESSFUL 
GRANT  APPLICATIONS  RFA-FD-1 1-002 

2012-8156 

11/14/2012 
12/12/2012 

CVM/OCD/ 

ORA/ 

ORA/ 

ORA/OCI/ 

ORA/OCI/ 

ORA/OE/ 

ORA/OE/ 

ALEX  R  LUMAGHI 
DOWD  &  DOWD  PC 

SCOTTS  CO  LLC  -  MIRACLE  GRO  MORNING  SONG  WILD 
BIRD  SEED  USE  OF  STORCIDE  II  AND  ACTELLIC  2E  RECS 

2012-8157 

11/14/2012 

FDA/OC/OES/DFOI/ 

OPERATION  TRIPLE  THREAT  -  POLICY  RECS;  INDIVIDUAL 

io/i  o/oni  o 

r\Aor  441  /y-4^4,  IjtUricit 

RECS 

2012-8158 

11/14/2012 
io/i  o/om  o 

1  eLl  1  d.ic\j  1  <i 

FDA/OC/OES/ 

JENNIFER  HSIEH 

HtALI MoAnt ntotAnOn 

CONSULTING  GROUP 

GILEAD  SCIENCES  MTG  -  ISSUES  OF  MUTIAL  INTEREST 
EMAILS  8/6/12 

2012-8159 

11/14/2012 
12/12/2012 

ORA/ORM/ 
ORA/ORM/ 

GAIL  LESSICK 

LACHMAN  CONSULTANT 
SERVICES  INC 

DRUG  COMPANIES,  MEDICAL  DVC  MFRS,  BIORESEARCH 
MONITORING  (BIMO),  ETC  -  DOMESTIC  AND  FOREIGN 
INSPS,  483S  9/1-30/12 

2012-8160 

11/14/2012 
12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

MARILYNN  WHITNEY 
COVINGTON  BURLING  LLP 

RED  BULL  -  CAERS  2004  TO  11/12/1 2 

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Subject 

201 2-81 61 

C—  \J  1  C—    U  1  U  1 

1 1/14/2012 

1    1  /   1  TV  LU  1  L 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1— / / V/  Vw/  1    l\J\    U  /  V 1  V  /  \w/  Vw/  L/  /  1  Vw/  VwJ/ 

MARILYNN  WHITNEY 

1  Vl/Tj  1  111       1  1  V  1  V    VVI   II  1  1  Ml   1 

COVINGTON  BURLING  LLP 

FIVE  HOUR  ENERGY  -  CAERS  2004  TO  11/12/12 

1     1  V  1        II  Vw/  KJ  1  1    1  1  V  1  1  1  V/   1          V_//  V 1  1  llj   C_  \J  Ut     1  Vw/     1    1  /   1  C—l    1  L— 

2012-8162 

1 1/14/2012 

1    1  /   1  TV  t_  W  1  L— 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  w  1               1  V/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

MARILYNN  WHITNEY 

i vin i  iil  i  i  vi  i   vvi  ii  i  i  1 1_  i 

COVINGTON  BURLING  LLP 

ROCKSTAR  -  CAERS  2004  TO  11/12/12 

1    l  V_/  V_/  1  V  O    1    1    \  1    I           V_/ 1    \  1  1     l\J     L—  \J  \J T^       1    Vw/       1     1  /     1  L—l     1  L— 

2012-8163 

fc-W  1  £_    VJ  1  V/  '-J 

1 1/14/2012 

1    1  /  1  T/  £—  v/  1  C— 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    ]  /  /  V/  Vw/  1    /  Vw/  1    V/ /  V 1  V/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

MARILYNN  WHITNEY 

1 V 1 1  \  1  1IL  1  1  VI  l    VVI   II  1  IV  l_  1 

COVINGTON  BURLING  LLP 

NOS  -  CAERS  2004  TO  11/1 2/1 2 

1  MVyw        \-J I  \  1—  1  \\J   L—  V/ V/ T^     1  Vw/     1    1  /    1  L—l  1 

2012-8164 

1 1/14/2012 

1     1  /    1  T/  t_  V/   1  L_ 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  \w/  1    ^w*  /  V 1  V/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

MARILYNN  WHITNEY 

i  vin  i  iil  i  i  vi  v  vvi  mi  iv  i— _  i 

COVINGTON  BURLING  LLP 

AMP  -  CAERS  2004  TO  11/12/12 

/  VI V  1  1  Vw / 1  \  l_  1  l  VwJ   L_  V/  V/ T^     1  Vw/     1    1  /    1           1  L— 

2012-8165 

t_W  1  £—    \J  1  V/  t^/ 

1 1/14/2012 

1    1  /   1  TV  £—  W  1  L_ 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    ]  /  /  V/  Vw/  1    /  Vw/  1    ^w*  1  \  1  V/  Vw/  Vw/  l_//  l_  Vw/  V-// 

MARILYNN  WHITNEY 

1  V  1 1  \  1  ll^l  1  VI  V    VVI   II  1  IV  1— —  1 

COVINGTON  BURLING  LLP 

REDLINE  -  CAERS  2004  TO  11/12/12 

1  1 1  1  >  1  1  1  V  1— —        \/M  1  1  I V/   L_  V/  «w/    l      1  Vw/     1    1  /    1  £-/    1  L 

2012-8166 

L—\J    1  C—    \J   1  V/V/ 

1 1/14/2012 

i  i  /  i  t/  t_  v/  i  l_ 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  1  \i  Vw/  1    /  \w/  1               1  V/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

MARILYNN  WHITNEY 

i  vin  i  iil  i  i  vi  v  vvi  mi  iv  i— _  i 

COVINGTON  BURLING  LLP 

FULL  THROTTLE  -  CAERS  2004  TO  11/12/12 

1    V/  1_  l_     1  1   1  1   l  Vw/  1     1  1—  1             V-/  /  V  l_  1  I V— '   L_  V/  V/    \      1  V^/     1    1  /   1  L—t    1  £_ 

2012-8167 

1 1/14/2012 

1    1  /   1  T/  £—  W  1  C— 

12/12/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    ]  /  /  V/  Vw/  1    /  Vw/  1    ^w*  /  V 1  V/  Vw/  Vw/  l_//  l_  Vw/  V-// 

OSTERHOLM,  MICHAEL  T 

LEAFY  GREEN  PRODS  -  LISTERIA  MONOSYTOGENES 

1  1  1  \  1      1     \J  1  1 1_  l_  1  V    1     1  l  Vw/  !_/              1  1  VwJ  1  1  1  1 1  /  V   1  V 1  Vw/  1  V  Vw /  Vw7  1     1  Vw /  Vwi  1  1  V  1  V/ 

INVESTIGATION  RECS 

2012-8168 

1 1/14/2012 

1    1  /   1  T/  t_  W  1  L— 

12/12/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          1  '  1      \l    Vw/  1  V  1   1             1     /  Vw /  lw/    |       11       |/    V_/  Vw /  l_  |       1/     1  /   |         Vw/  1/ 

Samantha  K  Slerid 

wcii  iiaiiLiia  i\.  vjiuvju 

Hall  &  Sethi,  PLC 

K042800 

1  VV/T£_  V/  V/  \J 

2012-8169 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

12/13/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LaVeeta  Moten 

INDIVIDUAL  RECS 

1  1  V  IS  1  V  1  1  f  V/  /  \  1—    1  1 1_  Vw/  Vw/ 

2012-8170 

L_  \_/  1  £_    VJ  1  /  V/ 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

04/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  1  \i  Vw/  1    /  \w/  1    ^w*  1  V 1  V/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

LaVeeta  Moten 

OVERTIME  AND  COMPENSATORY  TIME  PAID  TO  OFFICE  OF 

Vw/  V  1  1  l  1  1  1  v  1  1        1  V 1  V  J  /    \w/  Vw/  1  v  1  1  1— —  1  V  \w//»  1  Vw/  III       1  1 1 V  1  1— —    1     /  V 1  L/     1  V_/    V^/  1    1     1  Vw*  1        V^/  1 

MANAGEMENT  SYSTEMS  (10/01/2009-  11/08/2012) 

2012-8171 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

12/13/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

1  1— '  /  V/  Vw/  Vw^  1  I  V»/  1    /  Vw/  1  1/  V/        V  V     1    V*//  1  \/ VI  V 

DO/KAN-CB/ 

Doe  J 

PINES  INTERNATIONAL  INC  LAWRENCE  KS  -  483 

1     1  1  V  1— —  \J    1  1  V  1  1— —  1  1 1  V I  \  1  1  Vw/  1  V  /  V 1  ,    1  1  V  Vw/  ^    1  /  V  V  V  1  1 1— —  1  V  \J  1  j    IV  U          l  V/  Vw*  , 

DETERMINATIONS,  ETC 

2012-8172 

1 1/15/2012 

1    1  /   1  \JI  C—\J\C— 

12/13/2012 

OM/OMP/DODM/ 

Vw /  1  V 1/  V_/  1 V  1  1    /  1 — ^  Vw/  1  /  1 V  1/ 

Doe  J 

INDIVIDUAL  RECS 

1  1  V  L/  1  V  1  1  /  Vh/  /  \  1       1  I  L_  Vw/  Vw/ 

2012-8173 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

12/13/2012 

CVM/OCD/ 

Pampla  Ronpr 

1     Cll  1  1  w  1  d   UUI  1  v->  1 

PFIZER  ANIMAL  HEALTH 

NADA  135468 

1  V/  V  \S  1  V     1  V/i/^UU 

2012-8174 

11/15/2012 
12/13/2012 

CVM/OCD/ 

Pamela  Boner 

PFIZER  ANIMAL  HEALTH 

NADA  9467 

2012-8175 

11/15/2012 
01/29/2013 

FDA/0GR0P/0RA/PA-F0/L0S- 
DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Mary  Lynn 

The  Windward  Company 

HMS  VETERINARY  DEVELOPMENT,  TULARE,  CA  -  EIR 
(02/12-05/12) 

2012-8176 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

Eden  M  Venti 
Incyte  Corporation 

INCYTE,  WILMINGTON,  DE  -  EIR  (08/15/2011  -  08/19/2011) 

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Control  # 

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Subject 

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11/15/2012 
12/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— /  / V/  \w/ 1 V  1 1      1  /  V/  L/  1  11   1/  V_/V_/[  |  1/  I  /  I  v_/|/ 

Austin  MrFlrnv 

/VUOLIII    1  V  1  ^  - 1  1 1  \J  y 

Austin  McElroy 

K101239 

2012-8178 

11/15/2012 
12/13/2012 

OM/OMP/DODM/ 

Corinne  Cohen 
Abiomed,  Inc. 

CIRCULATORY  SYSTEMS  DEVICES  PANEL  -  TRANSCRIPTS 

08/21/95 

2012-8179 

1 1/15/2012 

1     1  /    1  \J/  L—\J\L— 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/ 1  \l  Vw/  1 V  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  V/  L-/  1  1  1/  \-s  III    /  1  /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Fmilv  7pitlpr 

l_  1  1  Illy             1  L 1  \D  1 

Emily  Zeitler 

DATA  SUBMITTED  TO  FDA  FROM  MANUFACTURERS  IN 

l_/  /  V  1  /  V  \w/  Vw/  1  '  1  V  1  1   1    1  1  L/     1  Vw/    1  1— /  /  V   III  Vw/  1  V 1    1 V 1  /  \  1  V!  Vw/  1    I  \  \  '  1  Vw/  1  1  1  1  l\J    1  1  V! 

SUPPORT  OF  ANDAS  FOR  GENERIC  CLOPIDOGREL 

2012-8180 

1 1/15/2012 

1    1  /   1  v-J/  t_V/  1  £_ 

12/13/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  LJ  1— —  1  1/  Vw/  V/  Vw/  L/  /  1  /  1  /  Vw/  1 V  1/ 

ALFB/ 

Yiiwpi  7hn 

VANDERBILT  UNIVERSITY 

INFLUENZA  VIRUS  VACCINE  TRIVALENT  TYPES  A  AND  B 

1  1  M  1    1  Vw/  1— —  1  >l  L  1  \    VIII  Vw/  Vw/     V  nV/v  1  1  M  1— —  ,     1  1  1 1  V  t  \  l_  l_  1  V!  1   ,     1     II     l_  K-)  1  \  1  V 1  >l  ]  /    1  1 

INITIAL  LOT  RELEASE  DATES  2006-2012 

2012-8181 

11/15/2012 
12/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Cristy  Jones 
jones,  cristy  j 

BARE  ESSENTIALS,  BARE  MINERALS,  SEPHORA  -  CAERS 

2012-8182 

1 1/15/2012 

1     1  /     1  \JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1 V  1  1      1  /  Vw/  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

Tina  Baho^ 

i  ii  ia  i — ' d u o 

ANDA  077742  -  TENTATIVE  APPROVAL  LETTER  1 1/02/2012 

/  vi  \  i_/  /  v  \j  i  i  i    i  l_       i  i  i  v  i  y  \  i  i  v  i— _  v  v  i    i    i  i  Vw/  v  /  \  i      i  i      i   i  i  ii    ii/  \j  L—i  C—  v/  i  C— 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1 V  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L*/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

IPD  ANALYTICS  LLC 

2012-8183 

fc-W  1  £_    VJ  1  VJ*_» 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClVt/l  Ivl   UUI  II  loul  1 

FOIA  DAILY  LOG  07/16-20/2012 

1    Vw/  1 1  \    L/  /  VI  1       1     1_  Vw/  Vw/    \J  I  1    1  V/    £_  v//  L_  v/  1  L_ 

12/13/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-8184 

1 1/15/2012 

1     1  /    1  \JI  L—\J\L— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1 V  1  1      1  /  W  L/  1  11   1/  Vw/  Vw*  1— —  1  1/  1 — /  1    Vw/  J/ 

Austin  MrFlrnv 

1  \  \A  O  LI  1  1    1  v  1  \-f  1  II  uy 

K081808 

1  VV/  V/  1  V/  V/  V/ 

12/13/2012 

FDA/OC/OES/DFOI/ 

Austin  McElroy 

2012-8185 

11/15/2012 
01/16/2013 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

]  /  Vw//  Vw' /  VI  >J    Vw/  L// 

none 

NOVARTIS  VACCINE,  EMERYVILLE,  CA  -  EIR,  483,  WARNING 
LETTER  ETC 

1          1               1          1       1            1       lj        l_      1  Vw/ 

2012-8186 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

LAKEWOOD  LLC,  LAKEWOOD,  NJ  -  EIR,  RESP  LTR,  CORR 
2/1 2  TO  3/12 

2012-8187 

■4  4  14  r"  ir~\f\  4  t~\ 

1 1/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

o i  ii —  n n  i  n  a  ~i — i~i —  n o i  1 1 —  i  i 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

i    a  i/i — i  a  /  s~\  /*"\  i- \  i  i  /-\    i    a  i/i —  \  b  //~v/™\  r~\    m  i       Ann    r™»  i —  *~i  n  i  ~ i~  n            n  n 

LAKEWOOD  LLC,  LAKEWOOD,  NJ  -  483,  RESP  LTR,  CORR 
2/1 2  TO  3/12 

2012-8188 

t—\J   1  L—    \J   1  VJV/ 

1 1/15/2012 

1     1  /     1  \JI  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1 V  1  1      1  /  Vw/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

SHESRRI BATTERSHELL 

VtaJ  1    1  1— —  \J  1    l  1    l  1  l— J 1  \  1     1    l_  1    l  \mmJ  1    1  l_  1  1  

pcpjCY  PERSONAL  CARE  PRODUCTS  ZHEJIANG  CHINA- 

1     1  1  I  Vw/  I     1     1  1  I  Vw'  Vw/  1  *i  1  \  1       Vw//  V  1  II        1     1  I  Vw/  L/  Vw/  Vw/  1  <wJ  .    £_l   II  ij  1  f\  1  V]  \_A  ,    V/  1    I  I  I  >J  n 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WASHINGTON  INFORMATION 
SOURCE 

EIR,  RESP  LTR,  CORR  3/12 

2012-8189 

11/15/2012 
12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHERRI  BATTERSHELL 
WASHINGTON  INFORMATION 

FERCY  PERSONAL  CARE  PRODUCTS,  ZHEJIANG,  CHINA  - 
483S,  RESP  LTR,  CORR  3/12 

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FDA/OMPT/CDER/ORP/DIDP/ 

SOURCE 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8190 

1 1/15/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

O  1  II —  1 — 11 — |  [— )  n  -i — p  1 —  1 — 1  f>  1  II —  1  | 

SHERRI  BATTERSHELL 

nniMPr  urniPAi  i —  n  o  I  no    [^n  a  M/"*rr     rin    n —  on  i  ~r n 

PRINCE  MEDICAL,  ERCUIS,  FRANCE  -  EIR,  RESP  LTR, 

12/13/2012 

WASHINGTON  INFORMATION 
SOURCE 

CORR  3/12 

2012-8191 

11/15/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

SHERRI  BATTERSHELL 

PRINCE  MEDICAL,  ERCUIS,  FRANCE  -  483,  RESP  LTR, 

12/13/2012 

WASHINGTON  INFORMATION 
SOURCE 

CORR  3/12 

2012-8192 

11/15/2012 
02/07/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

SUSAN  B  MILLS 
WEINBERG  WHEELER  ET  AL 

WEGMANS  FOOD  MARKETS  INC,  MONROE,  NIAGARA, 
STEUBEN  COUNTIES,  NY,  ETC  -  ORGANIC  SPINACH  & 
SPRING  MIX  BLEND  E  COLI  OUTBREAK 

OrtHO   OH  AO 

2012-8193 

4  4  14  C       C\  4  O 

1 1/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

o i  II —  n n i  da ~~\ — r i —  n  o  i  1 1 —  i  i 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

i\  a  i  n  /~»/™\  h  a  n  n/*"\    i  i  /~>  t  o    prMTn  a  i       it\/   n  a      rin    n  i —  on  i  t  n 

MIR-COM  PRODUCTS,  CENTRAL  CITY,  PA  -  EIR,  RESP  LTR, 
CORR  6/12 

2012-8194 

1 1/15/2012 

1    1  /   1  \J/  t_V/  1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— / 1  \i  Vw/ 1 V  1  1      1  /  \_/  1— /  1  1  1/  W  III    /  [_/  1  1  '  1  / 

SHERRI BATTERSHELL 

\S  1   1  l_  1  1 1  l  1    IS  I  \  1     1  l__  1  l  V/  1   1  1—  1  1  

HEMOFARM  A  D  VRSAC  SERBIA -EIR  RESP  LTR  CORR 

1   1  ^  1  v  1 V/  1    1  V 1  IIVI   /  \    IS  .     V  1  1 V/ 1  \  \S  .    V/  1—  1                \        1      1  1  l7    1  1 1  \S  1       L  1  1   lj    Vw/  Vw/  1  11  I 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

WASHINGTON  INFORMATION 
SOURCE 

11/11 

2012-8195 

11/15/2012 
12/13/2012 

ORA/ 
ORA/ 

FDA/OF/CFSAN/OCD/EOS/ 

CLAIRE  KALTENBACH 
CHILDRESS  AHLHEIM  CARY  LLC 

MULTISTATE  ROMAINE  LETTUC  E  COLI  OUTBREAK  - 
INVESTIGATION  RECS  201 1 

2012-8196 

11/1 5/2012 

1     1  /    1  \J/  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

SHERI BATTERSHELL 

\S  1   1  l__  1  l  1    IS  I  \  1     1  l__  1  l  V/  1   1  1—  1  1  

HEMOFARM  AD  VRSAC  SERBIA  -  483  RESP  LTR  CORR 

1   1  1  1 V  1  Vw/  1    1  V 1  1 1  V 1   /  \  \S  ,     VI  l  V/  /  \  Vw/  „    V/  1  1  1 1  /  \          i  \J  *_/  1    1   1  l__  V/  1       L  1  1   l|    V/  \  '  1  1 1  I 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WASHINGTON  INFORMATION 
SOURCE 

11/11 

2012-8197 

11/1 5/2012 

1    1  /   1         Llf  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \s  III    /  1 — '  1  1  /  1  / 

SHERRI BATTERSHELL 

\S  1   1  l_  1  1 1  l  1    IS  l  \  1     1  l_  1  l  V/  1   1  1—  1  1  

ZHONGNUO  PHARMS  SHIJIAZHUANG  CHINA -EIR  RESP 

L  1   1  V/ 1  i|  V_/  1  M  V/  V-/    1     1   1  /  V 1  IIVI  V/  ^    V/  1   1  1  VJ  1  /  V£  1   1  \S  t  \  1  >J  \s\  «    V-/  1    1  1  1  N  /  \        l_  III.    11  1  V/  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WASHINGTON  INFORMATION 
SOURCE 

LTR,  CORR  2011  TO  2012 

2012-8198 

L—\J    1   i—     \J    1  t/U 

1 1/15/2012 

1     1  /    1  \JI  L—\J  1  I— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  1 — '  1  l_/  1  / 

PAMELA  SHEPPARD 

1     i  \  1  V 1  1  \—l  \  V/  1   1  1  1     1     /  V 1  I  IS 

GENENTECH  -  ERIVEDGE  (VISMODEGIB^  NDA  203-388  SBA 

V_/  1  1  M  l_  1  M  1  l_  V/  1   1         1  1  1 1  V  1— —  IS  Vwl  1— —    1  V  1  Vw/  1  V 1  Vw/  ]  /  l_  Vwl  1  L/  /    1  N  IS  1  \  t—  \J  O    *_/  V/  V/   U  1  >  1  \  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TARO  PHARMACEUTICALS  USA 
INC 

RVWS,  LBLG,  ETC 

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Total  Records:  9990 


Control  # 

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Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8199 

11/15/2012 
12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHERI BATTERSHELL 

\Jl  II  1  ll    1  )  1  \  1    1  1  1  \  v  '  1  II  l_l  

WASHINGTON  INFORMATION 
SOURCE 

ZHONGNUO  PHARMACEUTICALS  SHI.IIAZHUANG  CHINA  - 

t—  1  Iv/MVJIMUvy  1    1  Itll  llvl/T^I  \J  1  1  Vjni  05   VJ  1  \\\i\r\i—  1  lUnllU;   \J\  1  1  1  Hi\ 

483,  RESP  LTR,  CORR  2012 

2012-8200 

1 1/15/2012 

1     1  /     1  \JI  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      11  \J  l—s  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

SHERRI BATTERSHELL 

\—)  i  1 1_  i  1 1  1 1  i  )  1  \  i    i  l_  i  i  \_)  i  1 1_  i  I  

ERCROS  SA  MADRID  SPAIN  -  EIR  RESP  LTR  CORR  7/11 

1  1    \\J  1    I  \w/  V  '    \-J  l\  .     1  V  1  f\  \-J  1    1  1  LJ  ,    V  '  1     / \  1  1  N          1  111;     11  1  Vj  1        1       III;           V_s  1   1 1   1     /  /    1  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WASHINGTON  INFORMATION 
SOURCE 

2012-8201 

1 1/15/2012 

1     1  /     1  \JI  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

SHERRI BATTERSHELL 

\j  1  1 1— _  i  1 1  1 1  l  >  i  \  i    i  l_  i  i \j  i  1 1_  i  I  

ERCROS  SA  MADRID  SPAIN  -  483  RESP  LTR  CORR  7/11 

1  1  l  w  1   I  v_/         V^J  7  \  ,    1  V  1 1  \  1 — /  1  1 1  L-/  ,    K-f  1    I  \  1  1  N           l  \J  \J  ,    1  1 1  ^/  1       l_  1   1   I  ,  \w /  Vw/  1  1 1  I    111  1 

■\mZI2Q\2 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WASHINGTON  INFORMATION 
SOURCE 

2012-8202 

1 1/15/2012 

1     1  /     1  \JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

PAMELA  SHEPPARD 

1     i  \  1  V 1  1  I—/ \  \J  1   1  1  1     1     /  \  1  1 1— ' 

ASTRAZENECA  LP  -  BRILINTA  fTICAGRELOR}  NDA  22-433 

/     V  Vw/    1     1     If     \  i.        1         1    N  1         Vw/  /     V      1        1                    1  )  1     l  1  ^  1  1    ll     1    I    \      1      1     1  \—S  I     \             1     1  1         l_  Vw/  11/      1    V  1  ^  1     \      L—  C— 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

TARO  PHARMACEUTICALS  USA 
INC 

SBA,  RVWS,  LBLG,  ETC 

2012-8203 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

SIEMENS  HEALTHCARE  DIAGNOSTICS,  NEWARK,  DE  -  483, 
RESP  LTR,  CORR  12/11 

2012-8204 

1 1/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

o i  ii —  n n i  da ~~\ — r i —  n  o  i  1 1 —  i  i 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

Oil —  r  n  i —  \  i  o  iii —  a  i  tm     a  n  i —  ni  a     k  i  f~\  o  ~r  i     o    Mr^\A/Ant/    r~\  i —  rin 

SIEMENS  HEALTHCARE  DIAGNOSTICS,  NEWARK,  DE  -  EIR, 
RESP  LTR,  CORR  12/11 

2012-8205 

1 1/15/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/        III    /  L*/  1  1  /  1  / 

CHRISTINE  FORGUES 

\J  1   1  1  1 1  \—}  1  1  1  N  1— —    1    \w/  1  I       \*J  l_  U 

VANCOMYCIN  HCL  CAPS  -  APRVL  LTR  12/21/1 1 

V  1  \  1  N  Vw/  VwX  1 VI   1  \J  1  1  N    II  \J  1       \_//\  1     w        /  V 1     1  1  V  l_   l_  1  1  1     1  £_/  t_  1  /   1  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MORGAN  LEWIS  &  BOCKIUS  LLP 

2012-8206 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

NEUROTHERM  INC,  WILMINGTON,  MA  -  EIR,  RESP  LTR, 
CORR  4/12 

2012-8207 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

NEUROTHERM  INC,  WILMINGTON,  MA  -  483,  RESP  LTR, 
CORR  4/12 

2012-8208 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/SW-FO/KAN- 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

CENTER  FOR  THE  IMPROVEMENT  OF  HUMAN  FUCTIONING 
INTERNATIONAL,  NEW  YORK,  NY  -  EIR,  RESP  LTR,  CORR 
7/11 

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DO/KAN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


2012-8209 


11/15/2012 
12/13/2012 


FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 


CENTER  FOR  THE  IMPROVEMENT  OF  HUMAN 
FUNCTIONING  INTERNATIONAL,  NEW  YORK,  NY  -  483, 
RESP  LTR,  CORR  7/11 


2012-8210  11/15/2012 
12/13/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


SHERRIBATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 


A  NELSON  &  CO  LTD,  LONDON,  UK  -  EIR,  RESP  LTR,  CORR 
11/11 


2012-8211 


11/15/2012 
12/13/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 


A  NELSON  &  CO  LTD,  LONDON,  UK  -  483,  RESP  LTR,  CORR 
11/11 


2012-8212 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

INNOVACYN  INC,  RIALTO,  CA  -  EIR,  RESP  LTR,  CORR  11/11 
TO  12/11 

2012-8213 

11/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

EILEEN  DANNEMANN 

MONOVALENT  H1N1  INFLUENZA  VAERS 

12/13/2012 

ALFB/ 

NATIONAL  COALITION  OF 
ORGANIZED  WOMEN 

2012-8214 

11/15/2012 
12/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

VIK  BAJNATH 
ARTHREX  INC 

MW#5027281 

2012-8215 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

MIR-COM  PRODUCTS,  CENTRAL  CITY,  PA  -  483,  RESP 
LTRS,  CORR  6/12 

2012-8216 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

SHERRI  BATTERSHELL 

WASHINGTON  INFORMATION 
SOURCE 

BIOMERIEUX,  DURHAM,  NC  -  EIR,  RESP  LTRS,  CORR  1/12 
TO  3/12 

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2012-8217 

1 1/15/2012 

OC/OM/OFM/ 

John  Crewdson 

LIST  OF  PAYMENTS  TO  FDA  PURSUANT  TO  PRESCRIPTION 

12/13/2012 

PROJECT  ON  GOVERNMENT 

DRUG  USERS  FEE  ACT 

OVERSIGHT 

2012-8218 

1 1/15/2012 

1    1  /   1     '/  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

Mirhplp  fiinnwav 

IVIIV^I  1  \j  1  *J   Vw/ 1 1  lUVVUjf 

RESOLUTION  CHEMICALS  STEVENAGE  UK  -  EIR  01/11 

1  1 1  V_/  1  1  1  V-/  1  >l    V/  1   1  1  IVII  Vw/  /  V  1_  VwJ  .    \J  1  1       V  1  1  *J  /  \  \-A  1  .    V/  1  V        l_  1  1  I   V/  1  /    1  1 

12/13/2012 

1      /   1  V//  £_U  1  £_ 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  1  \i  KJ 1 V  1  1      1  /  \_S  1— •*  1  1  1/  \J  III    /  1— /  1  L/  1  / 

1  3rhrnpn  Onn^nltpnt^ 

i— CIO  1  1 1  1  ICll  1  WUI  loUl  LCI  1  1  io 

rUA/UIVIr  1  /CUhK/OKr/UIL)r/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8219 

1 1/15/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Jeffrey  Green  /  Alex  Nussbaum  at 

a  /i  a  n  nu  a       ji  a     r~ i  i~ri a  i  o     t~^f~w^  n n i  i — r i —  ni —  o n/^\N  r o r~  i  i — i — r i —  n 

MAP  PHARMACEUTICALS  -  COMPLETE  RESPONSE  LETTER 

12/13/2012 

DO/NWE-CB/ 

Healthcor 

RE  LEVADEX,  CORR,  483 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

HEALTHCOR  MANAGEMENT  LP 

1   1  l—  l  \  L_  1  1   1  V/       II    1 V  1 1  V 1  4 1  \  V_-1  l_  1  V 1  1  1  il  1     1  1 

FDA/nMPT/nnFR/DRP/nmp/ 

r  vj  t\i  v_/ivi  n  i  /  o  i— /  r__  rv     i  \  i  /  i_/  i  vj  \  i 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8220 

11/15/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

Theresa  Appelbaum 

MEDRAD  AVANTA  FLUID  MANAGEMENT  INJEECTION 

12/13/2012 

DO/PHI-OB/ 

lj\j/  i   in  uu/ 

Padberg,  Corrigan  &  Appelbaum 

SYSTEM  -  INVESTIGATIONS  WARNING  LETTERS 

\J  1  \J  II  1  V  1        II  N  V  1  \J  1  1  V  A I  \  1  1  Vw/ 1  >J  <J  ,    V  V  ni  1 1  M  1 1  *J  Vw/   1  1       1    II  1  I  v  '  , 

FDA/OMPT/CDRH/OCER/DFOI/ 

RECALLS,  ETC 

2012-8221 

1 1/15/2012 

FDA/OMPT/CBER/OOOD/DDOM/ 

Rachel  Johnson 

ni    a  H  OCOir     \  1  r~\  a  OOOnO     Kin  A  An  <oo     i  r/^>       n  IOI/  rr\/AI  1  1  AT  I  /"V  K  1 

BLA1 25276,  NDA22383,  NDA22433,  ETC  -  RISK  EVALUATION 

12/13/2012 

ALFB/ 

FOI  Services,  Inc. 

AND  MITIGATION  STRATEGY  ASSESSMENTS 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

FDA/DMPT/nnFR/nRP/nmp/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8222 

1 1/15/2012 

1    1  /   1  v//  t_V/  1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

Joan  Stitt  (UG2CD-16^ 

UUul  1   WLIIL   I  \J  \J  L—  \J  1— /     1  \J  1 

ISR  7361599  7364893  -  DIRECT  REPORTS  MEDWATCH 

1  KJ  II    /  u\J  1  *J  \J  J  ,    /  V/  V/     V/ V/  1 — '  III  l_  V/  1     1  1 1  1     Vw/  III  O  ^    1 V  1  1— —  L/  V  V  1  \  1  V/  1  1 

FDA/nMPT/nnFR/DRP/ninp/ 

\  vj r\i v_/ivi n  i  /  \j vj r__ n/  v_/ 1 1 1  /  vj\vj\  i 

MFRHK  K  CCl  INH 

1 V 1 1  1  1  v/ 1\  CX  \J\J.,  l\\\j. 

REPORTS,  SOURCE  DOCUMENTS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8223 

1 1/15/2012 

1     1  /     1  \JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

Joan  Stitt  fUG2CD-16^ 

LlUai  1    WLILl   1  VJVJLWLf     1  \J  1 

ISR  7287296  8227773  8337499  83741 56  -  DIRECT 

1  KJ  11/  L_  V/  /  £_  \J \J  ,    V/ c_ £_  i    1    1  \J  y    \J\J\J  1       %_/      ,    L/ w  /  "  1  \J\J        L/  1  1  1 1  V/  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  /  V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  Vw/  III    /  !_/  1  L/  1  / 

MERCK  &  CO  INC 

IVII  1  l\_M\  LX    \J\J  .  ,  IIWJ. 

REPORTS,  MEDWATCH  REPORTS,  SOURCE  DOCUMENTS 

FDA/nMPT/nnFR/DRP/ninp/ 

n  vj t\i  v_/ivi  n  i  /  \j vj  r__  n/  v/ 1 1 1  / 1_/ 1  vj \  i 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8224 

11/15/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

SHERRI  BATTERSHELL 

BIOMERIEUX,  DURHAM,  NC  -  483,  RESP  LTRS,  CORR  1/12 

12/13/2012 

DO/ATL-CB/ 

WASHINGTON  INFORMATION 

TO  3/1 2 

SOURCE 

2012-8225 

11/15/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

SHERRI  BATTERSHELL 

CELLTEX  THERAPEUTICS  CORP,  SUGARLAND,  TX  -  EIR, 

12/13/2012 

DO/DAL-CB/ 

WASHINGTON  INFORMATION 

RESP  LTRS,  CORR  4/12 

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FDA/OMPT/CBER/OCOD/DDOIW 

SOURCE 

ALFB/ 

FDA/OGROP/ORA/SW-FO/DAL- 

DO/DAL-CB/ 

2012-8226 

11/15/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

SHERRI  BATTERSHELL 

CELLTEX  THERAPEUTICS  CORP,  SUGARLAND,  TX  -  483, 

12/13/2012 

DO/DAL-CB/ 

WASHINGTON  INFORMATION 

RESP  LTRS,  CORR4/12 

FDA/OMPT/CBER/OCOD/DDOM/ 

SOURCE 

ALFB/ 

FDA/OGROP/ORA/SW-FO/DAL- 

DO/DAL-CB/ 

2012-8227 

1 1/15/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

o  i  ii —  n  n  i  n  a  t — i~i —  n  o  i  1 1 —  i  i 

SHERRI  BATTERSHELL 

IK  IK  1  /~\\  /  A  /~i\/K  1    IK  1  /~i      r™t  1  A  1  /~ »  A          A  f~i1~t    4  4  /  4  4    ~T"/™\    4  f~\  14  4 

INNOVACYN  INC,  RIALTO,  CA  -  483  1 1/1 1  TO  12/1 1 

12/13/2012 

DO/LOS-CB/ 

WASHINGTON  INFORMATION 

SOURCE 

rtnH  r~\  noon 

2012-8228 

1 1/15/2012 

i- r^v  a  //~\ r  a d~t /o nnu  //->» /~> ■ —  n  /n i — /"\ i  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

o  i  ii —  n  n  i  da  ~~\ — r  i —  noi  1 1 —  i  i 

SHERRI  BATTERSHELL 

i  i —  ioi —  s~\  a  iv  i  i —  i —  i  k  i  ft  n\ — i  i  ami  \x  /~\  D~r  \\x    nrni  im  f  \  i —  n  ft  d  am  \/ 

LEISEGANG  FEINMECHANIK-OPTIK,  BERLIN,  GERMANY  - 

12/13/2012 

WASHINGTON  INFORMATION 

EIR  4/12 

SOURCE 

2012-8229 

1 1/15/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

SHERRI  BATTERSHELL 

1     l~~  1  f~^>  I~  /"N  A  K  1           |~~  I-—  Ik  IK  il  l~~        1    1  A  Kill/  [""X- T"  1  I  y       r~l  I~        I     1  K  1              I-—        ■   ■  *  K  1  \  / 

LEISEGANG  FEINMECHANIK  OPTIK,  BERLIN,  GERMANY  - 

12/13/2012 

WASHINGTON  INFORMATION 

4ft^  4/1 P 

too  *+/  1  c 

SOURCE 

2012-8230 

1 1/15/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

SHERRI  BATTERSHELL 

SPINEFRONTIER  INC,  BEVERLY,  MA  -  EIR  5/12  TO  7/12 

12/13/2012 

DO/NWE-CB/ 

WASHINGTON  INFORMATION 

SOURCE 

2012-8231 

1 1/15/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

o i  ii —  n n i  da ~\ — r i —  n  o  i  1 1 —  i  i 

SHERRI  BATTERSHELL 

SPINEFRONTIER  INC,  BEVERLEY,  MA  -  5/12  TO  7/12 

12/13/2012 

DO/NWE-OB/ 

WASHINGTON  INFORMATION 

SOURCE 

2012-8232 

1 1/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

(~i i  ii —  n n i  da ~\ — r i —  n o i  1 1 —  i  i 

SHERRI  BATTERSHELL 

oak  i     t~  i  r~\  a  o~r  i —  i  in    kaa  n    \/  i  1 1 — rf  \  1 1  r~  i —  n  a  k  ip  r~     rm  o  /h  *~>  ~r/~\ 

SANOFI  PASTEUR.  IVIAROY  L  ETOILE,  FRANCE  -  EIR  3/12  TO 

12/13/2012 

ALFB/ 

WASHINGTON  INFORMATION 

4/1 P 

SOURCE 

2012-8233 

1 1/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

o i  ii —  n n  i  r~i  a  ~i — i~i —  n o i  1 1 —  i  i 

SHERRI  BATTERSHELL 

OAK  l/™\  1 —  1    DA  OTI —  1   1  n      K  A  A  n  0\  /    1 1 1  l~y*~\  1  1  1 —  1 —  n  A  K  1  /"">  1 —         A  t~t/~t    ft  1 4  f~i  1  

SANOFI  PASTEUR,  MARCY  1  ETOILE,  FRANCE  -  483  3/12  to 

12/13/2012 

ALFB/ 

WASHINGTON  INFORMATION 

4/12 

SOURCE 

2012-8234 

4.  4.  14  E  ll~\f\4  O 

1 1/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

o i  ii —  n n i  da ~\ — r i —  n o i  1 1 —  i  i 

SHERRI  BATTERSHELL 

OAK  1  /"N 1 —  1    r~\  A  OT- 1 —  1  ID   1  TR     ~T^\  D/™\  N  l~r/""\     O  ANIADA        rm    ii  /H  O 

SANOFI  PASTEUR  LTD,  TORONTO,  CANADA  -  EIR  4/12 

12/13/2012 

ALFB/ 

WASHINGTON  INFORMATION 

SOURCE 

2012-8235 

11/15/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

SHERRI  BATTERSHELL 

SANOFI  PASTEUR  LTD,  TORONTO,  CANADA  -  483  4/12 

12/13/2012 

ALFB/ 

WASHINGTON  INFORMATION 

SOURCE 

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2012-8236 

11/15/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

ZIV  HAREL 

i—  1  V     1   1 1  \  1  11  1  

PRADAXA  VERSUS  WARFARIN  -  AER 

i   i  ir\ur\/\r\  v  i  i  i v./ VwJ vvni  ii  /  \ i  iii  n     ni  i  i 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ST  MICHAELS  HOSPITAL 

2012-8237 

1 1/15/2012 

1    1  /   1  \J/  t_V/  1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  1  \i  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

ADRIENNE  E  FAERBER  PhD 

I  \  1— /  1  l  1  1  1  VI  <l  1        l__  ■    1    1  \  1  1  1 1  >  l__  1  1 3    1     II  1— / 

POMOTIONAL  MATERIALS  FOR  ZYRTEC 

1     Vw/ 1  v  1  Vw/  1   1  Vw/  1  >J  /  V  l_   1 V 1  /  \  1  l_  1  l  1 1  \  1  \_)    1  Vw /  1  l  £      1   1  l  1  1  v./ 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DARTMOUTH  INSTITUTE 

2012-8238 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  V  1  1       1  /  V/  L*S  1       1    1/  \-S  III     /  1 — f  I  L-/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

ROBIN  WINCHESTER 

KESSLERTOPAZ 
MELTZERCHECK  LLP 

ABIOMED  INC  -  EIRS,  WARNING  LTRS,  CORR  1/28/10, 
6/10/11,4/12,  ETC 

2012-8239 

11/15/2012 
12/13/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

SUSAN  B.  MILLS 
WEINBERG  WHEELER  ET  AL 

CIRCLE  G  RANCH  WILD  ANIMAL  PARK  &  CAMEL  SAFARI, 

c~~\ ~r~ i — \  a  \  a  / r~>  i —  n  n\/  r-n    a  imo    t" k  i  i —  /~»/*"\ i  i       i  n~n  n  i —  a  i / 

STRAWBERRY  PLAINS,  TN  -  E  COLI  OUTBREAK 
CLEVELAND  COUNTY  FAIR,  NC 

2012-8240 

1 1/15/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

i  i — '  /  v/  \w/ 1  v  1 1     i  /  v/ 1_/  i  i  i/  w  ill   /  I— /  1 1_/  i  / 

ROBERT  M  DISOGRA  Au  D 

1  1 l— J  1  1  11     1  v  1  .  1 — '  1  \-}  V_/  \-A  1  I  /  \  1    /  \UI .  I_/  ■  ■ 

EAR  PERFECT  -  INGREDIENTS 

1  1     I  III        l_  1     II       l_  Vw/     1                 1  1   >l  Vwl  1     1  l_  1— /  |  1         111  Vw/ 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  \—S  1  L*/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FAAA 

AUDIOLOGY  ASSOCIATES  OF 
FREEHOLD  PC 

2012-8241 

11/16/2012 
12/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Sheetal  Pandya 
TekTeam  LLC. 

K071364 

2012-8242 

11/16/2012 
12/14/2012 

OC/OOPD/ 

FDA/OMPT/OSMP/OOPD/ 

Holmes,  Warren 

ECULIZUMAB  FOR  THE  TREATMENT  OF  IDIOPATHIC 
MEMBRANOUS  GLOMERULAR  NEPHROPATHY  -  ORPHAN 
DRUG  DESIGNATION 

2012-8243 

11/16/2012 
12/14/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

CTP  RECS  COLLECTED  FROM  STATE  HEALTH 
DEPARTMENTS  ON  ADVERSE  EVENTS  RE  E-CIGARETTES 

2012-8244 

1 1/16/2012 

1  1  /  1  \JI  t—  \j  \  t— 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  L/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Marta  Arrahpll 
Lahoratorio^  Le^vi  S  L 

INTERNATIONAL  PHARMECEUTICAL  RESEARCH  CENTER 

1 1  M  1  1— —  1  VI  \  /  \  1   1  Vw/ 1  y§/  \  |       |     |   1 1  \  |  1 1  v  1 1  Vw/  1  Vw/  1  1  Vw/  /  V  L_    1  1 1  V_/  1  r  \  1  1  v/  1   1    \—t  1— —  1  il  1  l_  1  I . 

AMMAN,  JORDAN  -  LAST  TWO  483S 

2012-8245 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Matt  Prokopczyk 

SIMVASTATIN  TABLETS  USP  -  HEALTH  HAZARD 

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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      11  \J  \S  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DR.  REDDY'S  LABORATORIES 
INC 

EVALUATION 

2012-8246 

11/16/2012 
12/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Sheetal  Pandya 
TekTeam  LLC. 

K001284 

2012-8247 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  v_/  III    /  IS  1  ]  /  1  / 

VIPOR  CHEMICALS  LTD  INDIA  -  483  (12/01/2006  - 

VII     V/  1  1    Vw/  1   1  1  1 V  1  1  \S  t  V  I— V_J    1      1  IS  .    1  1  >l  IS  1  /  V          i  \J  O    I    1  ^/  V/  1  /  L_  \_/  V/  V/ 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DDD  Ltd 

12/31/2006) 

2012-8248 

1 1/16/2012 
12/20/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

OM/OSS/OPILS/FDAHO/ 

Henry  Gluckstern 
HENRY  GLUCKSTERN 

ORAL  POLIO  VACCINE  -  TEST  RESULTS  (01/01/1960  - 
12/31/1999) 

2012-8249 

11/1 6/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  I  \i  Vw/ 1  v  1 1     1  /  V/  L/  1  1  1/  V/  III    /  is  1  1— '  1  / 

SEPARATE  RPTS  OF  ADVERSE  SIDE  EFFECTS  2000  TO 

V/ 1  1     /  VI   1/  \  1  1        1  II      1          Vw/  1      1  \  IS  V  L  1  I V/ 1—    U  1  1/  L.    1  1     1     l_  V/  1  \S    L—\J\J  \J     1  Vw/ 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \i  Vw/ 1 V  1 1      1  /  \S  IS  1  1  1/  \s  III    /  !_/  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

CORRENS,  DOERTE 

PRESENT 

2012-8250 

1 1/16/2012 
12/14/2012 

FDA/OGROP/ORA/PA-FO/SEA- 

i  is  i v/  \w/  v^i  i  i  v_/ 1  /  v_/ 1  inn  / \  i  \_//vji  / \ 

DO/SEA-CB/ 

JAMES  A  LOCHRIDGE 

vj  i\  i  v  1 1  w  n  i  \w/  v/ 1  ii  1 1  l/  \s\  i  

PREIS  &  ROY 

KIRKMAN  GROUP  INC  KIRKMAN  LABS  -  STEVIA  SWEVIA 

i  \  1 1  1 1  \  i  vini  v  \s\  i  i  V-/  v/  i     1 1  >i  v_/ ,           1 1  vi  v  i  /  v  i  m  i_y  \  is  \s      v_/  i  i  v  i  /  \  v/  v  v  i     v  i  /  \  ■ 

LIQUID  ZINC  LAB  ANALYSIS  1/10 

2012-8251 

11/16/2012 
12/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

PETER  T  ANDERSON  ESQ 
ASHCRAFT  &  GEREL  LLP 

K030497 

2012-8252 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1   If  v_/  III    /  !_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHAPIRO,  JOEL 

DR  BURZYNSKI  BURZYNSKI  RESEARCH  INSTITUTE  CBRh  - 

IS  1   1    1  }  \S  1  1  £.      1  1  il  \—J  1  \l  j    IS  \S  1  I Z       1   1  *J  *S  1  \  1    11 1  1  /  VI  1  v/  II    1  1  >l        1  1  1   *S  1  1— —    \  IS  1  11/ 

NOTIFICATION  LTR 

2012-8253 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/ 1  v  1 1      1  /  V/  IS  1  1  1/  \S  III    /  I — '  1 1  /  1  / 

KATHLEEN  KOONS 

E  V/  \  1  1    1  L_  l_  l_  1  M    1  V  Vw/  Vw/  1  N  U 

SUBOXONE  FILM  NDA  22-410  -  SBA 

*w/  Vw/  1— '  Vw/  /  V  V/  1  >l  l_    1     1  ^  1  v  1    IV  IS  1  \   t—  L_          1  V/          V_J  1  '  /  \ 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DJA  GLOBAL 
PHARMACEUTICALS  INC 

2012-8254 

11/16/2012 
12/14/2012 

FDA/OC/OES/DFOI/ 

ELENA  HOWELL 
HOGAN  LOVELLS  US  LLP 

2012-7560 

2012-8255 

11/16/2012 
12/14/2012 

FDA/OC/OES/DFOI/ 

DARREN  BROWN 

PROVOST  UMPHREY  LAW  FIRM 

DR  ERIC  WILHELMSEN,  WILHELMSEN  CONSULTING  - 
INGREDIENT  DECLARATION  FOR  VARIOUS  SWEETNERS 
FDA  GUIDANCE  LTR  5/8/2000 

2012-8256 

11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 

DR  MED  KURT  LOBODASCH  SURGICAL  MESH  LTR  8/3/12 

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ooniroi  ff 

necu  uaie  / 

MCTIOll  VjTTICt? 

vjignaTure/  riequesier 

ouujeci 

Due  Date 

12/14/2012 

BUTLER  SNOW  ET  AL 

(CERTIFIED) 

2012-8257 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  VJ  1  v  1  1      1  /  VJ  U  1  1  1/  \-s  III    /  I — f  A  U  A  1 

PATRICK  A  DAWSON 

1    t  \  1  1  l  1  VJ  1  \  1  V  1— /  /  \  V  V  VJ  V_/  1  >l 

EPIPEN  EPINEPHRINE  INJECTOR  PEN  -  LBLG  EXPIRATION 

1  1     1  1     l__  1  N    1  1     1  1  >l  l_  1     1    1  1   11  1  \1  1        1  1         1  VJ  1  VJ  1  I    1  1— —  1  il        l_ U  1_ v^ ,           V 1     1  1  1 1  V  1  1  VJ  1  N 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

COOPER  FIRM 

DATE 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8258 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    U  1  \l  VJ  1  v  1  1      At  VJ  IS  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

ERIN  E  SEDER 

l__  1    M  1  N     l_    VJ  1       U  1  1  I 

INTERNEURON  PHARMACEUTICALS  INC  -  IND  APPLS  1990 

MM  1  1— —  1  1 1  *l  l__  VJ  1  I  VJ  1  X    1     II 1  \  A  1 1  v  1/iVJ  1  \J  1  1  VJ  /  V  L_  VJ    1  1  M  VJ        1  1  M  U   /  \  1     1     1  VJ     1  J  J  V/ 

12/14/2012 

1  C—l  1  *~r/  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  1  V/  Vw/ 1 V  1 1      1  /  Vj  U  |  |  1/  V_/  III    /  U  1 1  /  |  / 

VENABLE  LLP 

v  i  i  inu i  i      i  i  i 

TO  2000 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  U  1  1  1/  > — /  III    /  LJ  1  U  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

C\J  I  d  \JC-\J<3 

1  1  /  1  \Ji  C\J  \  (— 

FDA/OfiROP/ORA/PA-FO/l  D^- 

a    VJ  r\l  Vjvj  I  I  v_/ 1   /  vj  llrA/  1    /\  1  VjV  l_  v_/  o 

DIANA  R  MARTINI 

VJ  1  f\  \  h  f  \  1  l  IV 1  f\  \  1  1  IINI 

I1R  RA  llll  1  PATFI    MARICOPA  INTFfiRATFD  HFAI  TH 

L/n  1  \r\\J  \J  1  1  in  1  1  1  .  1 VI  /  \  1  1 1  Vj  Vj  I    r\  MM  1  1  VJI I  \t  \  1  \  L/  1  1 1  r\  L_  1  1  1 

12/14/2012 

DO/LOS-CB/ 

UVJ/  1 — VJvJ   V-/  LJ/ 

VITAL  THERAPIES 

SYSTEM  -  483  8/1 3/03 

VJ  I  vj  1  1 — IVI       "TV/vJ  VJ/  1  \Jl  \J\J 

2012-8260 

4  4  14  /"*  lr~\f\  4  O 

1 1/16/2012 

FDA/OC/OES/DFOI/ 

Tony  Collins-Kwong 

ni  i  a  nil  ii —  r^v 1 1  \w  a     yiooo  / r\4  ir\ 4  i <~\r\ r\ ~7     4  4  14  a  /or\ h  o\ 

PHARMEDIUM  -  483o  (01/01/2007  -  11/14/2012) 

12/14/2012 

FDA/OGROP/ORA/SW-FO/DAL- 

ALLINA  HEALTH  SYSTEM 

DO/DAL-CB/ 

o/~n  o  one?  ■( 

^01  iL-o2x>\ 

1 1/1 6/^01  ^ 

rUA/Olvlr  1  /OUKH/UOtK/UrOI/ 

CAITLIN  CAREY  MINER 

a  h  a  i —  ni  s~\  am  n  (irni  /~*  a  i    o \/ o  ~r  i —  ft  /i  o  i  n  i         o  i  in     i     a  i  km —  01  i 

AMERICAN  MEDICAL  SYSTEMS  INC  -  SURGICAL  MESH 

12/14/2012 

HARE  WYNN  NEWELL  & 

RPTS 

NFWTDN 1 1 P 

1  N  1  VV  1  VJ  1  N  L_l_  \ 

2012-8262 

1 1/16/2012 

I    I  /  I  \JI  £—\J  1  t— 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  / V/  Vw/  1    /  VJ  1    U  /  V 1  \J  /  Vw/  VJ  L/  /  1  VJ  Vj/ 

SOYA  SOYBEAN  -  CAERS  STUDIES  MEMOS  ETC 

vj  vj  i  n,  vj  vj  i  ui  /  v  i  m      vjni  i  i  vj .  vj  i  uuii  o,  ivii  ivivjvj,  i      i  vj 

a  r\  14  a  li~\f\  4  O 

12/14/2012 

JORDAN  #B24482,  VALDEZ 

2012-8263 

11/16/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

LARRY  R  ROGERS 

CYBERONICS  MODEL  102  23437,  MODEL  103  SN  19766  - 

03/11/2013 

DO/CHI-CB/ 

POWER  ROGERS  &  SMITH  PC 

INVESTIGATION,  STUDIES,  TEST  MATERIALS,  ETC 

rUA/OMr  1  /OUKH/UOtK/UrOI/ 

F  D  A/OG  ROP/0  RA/S  W-  FO/D  AL- 

DO/DAL-CB/ 

2012-8264 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  U  1    Vw/  Al 

LAUREN  S  BARR 

1  1  \  vj  1  1 1— _  1  ii  vj  u  1  \  1  1 1  1 

FOI  DAILY  LOG  10/29/12-11/2/12 

1    VJ  1    U  /  VI  1       1     L_  VJ  VJ     A  \JI  L—  \J  1    1  L-      1    1  /  ^/    1  L_ 

12/14/2012 

1  C—l   1  TV  £_  \J  A  C— 

JH  BARR  S  ASSOCIATES  LLC 

\j\  1  urvi  11  1  <_x  nuuv/v/  ir\  1  1  vj  i_i_vj 

2012-8265 

1 1/16/2012 

1     1  /     1  \Jl  L—\J\C— 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  U  1    Vw/  Al 

LAUREN  S  BARR 

1  I  \  vj  1  1 1— _  1  *i  vj  u  /  v  1  11  1 

FOI  DAILY  LOG  10/22-26/12 

1    VJ  1    U/  V  1  1—  1     L_  VJ  VJ     |  V/ /  L—  £_    ^_  V//    1  £_ 

A  C—l   A  TV            1  L 

IH  RARR  R,  ASSOHIATFS  1  1  C. 

U  1  1  l—)f\  1  1 1  1  Ot  /AO O v/ vj  1  /  \  1  l_0  L_ L_Vj 

2012-8266 

1 1/16/2012 

1  1  /  1  \JI  t—\J\i— 

FDA/OF/CFSAN/OCD/EOS/ 

1    U  /  V/  VJ  1    /  VJ  1    VJ/%  1  M/  VJ  VJ  U/  1— —  VJ  VJ/ 

JOHN  LYONS 

V/  VJ  1    1  1  >l    1—  1  VJ  1  M  \  J 

5-HOUR  ENERGY  MONSTER  ENERGY  VITAMIN  WATER 

v_y    1   1  VJ  VJ  |  1    1  I  M  l__  I  I  VJ   1    ,    IVI  VJ  1  *J  VJ  1  1  1  1    l_  1  VI  l_  1  1  VJ   1  .     VII  1  \  1  V 1  1  1  VI    V  V  /  V  1  1  1  I . 

12/14/2012 

FDA/OC/OES/DFOI/ 

John  Lyons 

ETC-AERS  (11/01/2007-  11/15/2012) 

2012-8267 

1 1/16/2012 

0M/0MP/D0DM/ 

Desmond  Jenson 

FDA-2010-N-0568  -  COMMENTS  NOT  AVAILABLE  ON 

12/14/2012 

Tobacco  Control  Legal  Consortium 

REGULATIONS.GOV 

2012-8268 

11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Joy  Frestedt 

K1 12342 

12/14/2012 

FRESTEDT  INCORPORATED 

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Total  Records:  9990 


V_/UI  III Ul  tt 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  nULjUtJolci 

OUUJtfOl 

Due  Date 

2012-8269 

11/16/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

elizabeth  matovinovic 

ADVATE  -  AERS  07/15/03  TO  PRESENT 

12/14/2012 

1  C—l  1  *~r/  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  A— 1 1   \i  Vw/  1  V  1  1       1  /  V_/  L/  |       |    1/  V_/  III     /  [_/  |  j  1  |  / 

1  1  1  CI  l\J  V  1 1  1  \J  V  1  K-r ,   CI  1  liaUC  LI  1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 

a  i  i- n  / 

ALFB/ 

2012-8270 

1 1/16/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

ROBERT  MOSIER 

n  a  mi  iri  /~\  a  mh  hiA-ri  ihai  \/~t  i —      n \/  a     i  r~\         \  \  i —  is  itd  a  ~r  i — 

GRANUFLO  AND  NATURALYTE  DRY  ACID  CONCENTRATE  - 

4  r\  14   A  ll~Af\  4  o 

12/14/2012 

DO/NWE-CB/ 

1  |  /-\  1 — \  I —  O    h  fl  1 1    II  AM   1    1  I —  n  I —  /~>  \S 

HODES  MILMAN  LIEBECK 

RECALL  RECS 

FDA/OMPT/CDER/ORP/DIDP/ 

MOSIER,  LLP 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  V/  L*/  1  1  1/  \-s  III    /  1 — /  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1  1      1  /  \J  A—i  1  1  1/  V/  III    /  1— '  1  1— '  1  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

O  A  H  O  00"7  ^ 

201 2-8271 

4  H           /OA  ^  O 

1 1/16/2012 

rUA/UMr  1  /OUKH/UOtK/UrOI/ 

Reed  Kathrein 

ADiArflcn           n n         ao/o>i/ho  r/1"t/^ 

AdIUMcU  -  OUKK  Kt  02/24/1 2  Ivl  I  \j 

12/14/2012 

HAGENS  BERMAN  SOBOL 

SHAPIRO  LLP 

2012-8272 

11/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Reed  Kathrein 

ABIOMED  -  FOLLOW  UP  TO  WARNING  LETTER  (04/12) 

12/14/2012 

HAGENS  BERMAN  SOBOL 

SHAPIRO  LLP 

2012-8273 

1 1/16/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Reed  Kathrein 

a  n  i/*^  r  a  i —  r~\      aii       s~\  n  n  n  i —  i  h  d  n  i —  i  i  a      i  a  i  k  a  o    r~i  n     i\  a  f~\~r        i  o 

ABIOMED  -  ALL  CORR  RE  IMPELLA  CLAIMS,  PROMOTIONS, 

12/14/2012 

HAGENS  BERMAN  SOBOL 

MARKETING  ETC  (01/12/2009  -  1 1/15/20121 

1 V  11   VI    I  1  \  1— —  1    1  1  *l         ,     1        1   Vw"    \  \J    1  /    1  C—l  C—  \J  V/  v/           1     If    1  v//  L—  \J   1  L—  J 

SHAPIRO  LLP 

2012-8274 

1 1/16/2012 

I    I  /  I  \Jf  L-  \J  1 

FDA/OMPT/CTP/OD/ 

1  A— 1 1  \i  Vw/ 1 V  1  1      1  /  \J  1  A    1  Vw/  L/  / 

Raphpl  .lohnQon 

1  IQ<jI  lul  UUI  II  IOUI  1 

OTP  REPORT  RE  MENTHOL  CIGARETTES 

V/  1    1        1   11  1     Vw/ 1   l   1      1   11         IVII  1  \   1   1    1  Vw/ 1        V  /  1  V  j|  /   \  1    11        1     1    1  \J 

12/14/2012 

FOI  Services,  Inc. 

Of~H  O  007C 

4  H  HC  /OA  ^  O 

1 1/16/2012 

rUA/UG/Uhb/DrUI/ 

Reed  Kathrein 

ADlOMhU  -  HtOo  ritLtAbtU  UNUtH  rUIA  IN  dQ\2. 

12/14/2012 

HAGENS  BERMAN  SOBOL 

SHAPIRO  LLP 

2012-8276 

1 1/19/2012 

1     1  /     1   xjl  t—\J\l— 

FDA/OF/CFSAN/OCD/EOS/ 

1  i — '  1  \l  Vw/  1    /  V/  |    v//\  1  M/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Ppfpr  H^ll 

1     v7        1     1  IOU 

CAERS  REPORTS  139012  139013 

W/   \  1  1    I  Vw/    1    1 1_  1     Vw/  1    1  1   U      1  W«JU   1  L_  ,      1  v/  v/  v/   1  \J 

12/17/2012 

1  C—l   A  1  1  C—\J  A  C— 

I   CLCI    1  IOU 

2012-8277 

1 1/19/2012 

1     1  /     1   \JI  L—\J\C— 

FDA/OF/CFSAN/OCD/EOS/ 

1          1  /  /      V/     Vw/   |        /    Vw/  1         ^/  /      \  1     *J/     Vw/  Vw/  1  /  /     l_  Vw/  *w// 

FCN  899  FCN  915  -  SAFETY  EVALUATION 

12/17/2012 

Scott,  Michael 

2012-8278 

1 1/19/2012 

i  i  /  i  \jt  t —  v/  i  l — 

ORA/ 

Tom  Burton 

AMERIDOSE  LLC,  NEW  ENGLANG  COMPOUNDING  CENTER 

12/17/2012 

ORA/ 

WALL  STREET  JOURNAL 

-  ORA  RECS  (01/03/2005  -  10/01/2012) 

2012-8279 

11/19/2012 

FDA/OC/OES/DFOI/ 

MADHU  SONI 

MONSTER  ENERGY  DRINKS  -  CAERS  1/12  TO  PRESENT 

12/17/2012 

SON  1  &  ASSOCIATES  INC 

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 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8280 

11/19/2012 
12/17/2012 

FDA/OC/OES/DFOI/ 

RACHEL  A  AVAN 
LABATON  SUCHAROW 

MONSTER  BEVERAGE  CORP  HANSEN  NATURAL  CORP)  - 
ENERGY  DRINKS  CAERS 

2012-8281 

11/19/2012 
12/17/2012 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

TOTAL  NUMBER  OF  ORDERS  OF  SUBSTANTIAL 
EQUIVALENCE  ISSUED  UNDER  FAMILY  SMOKING 
PREVENTION  AND  TOBACCO  ACT  09/01/12  TO  10/31/12 

2012-8282 

1 1/19/2012 

1  1  /  1  \JI  t—\J\i— 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  Vw/  1 V  1  1      it  \S  \S  1  11   1/  \-s  \-S  1—  1  1/  1 — /  1    Vw/  1/ 

ALELXANDER  FILATOV 

1  \  1  1  1  /\l  \  1  M  IS  1  III     1 1  1  \  1  Vw/  V 

PARASCRIPT  LLC 

ICAD  -  SECONDLOOK  CAD  SYS  P010038/S013  USER 

1  V/ 1  \ IS       \j  1  Vw/  Vw/ 1  N  IS  1  V_/ \s  1  \  V/ 1  \  \S  \w>  1  \J   1    \J  1  \J\J\J\JI  \J\J  1  Vw*   \s  w  1  1  1 

MANUAL  LBLG,  SS&E 

2012-8283 

11/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Michelle  Minton 

CAERS  -  ALL  FOOD  AND  DRINK  PRODUCTS  LAST  FIVE 

12/17/2012 

The  Competitive  Enterprise  Institute 

YEARS 

2012-8284 

1 1/19/2012 

1     1  /    1  \JI  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

.lakp  Narhmani  F^n 

RISPERDAL  -  OFF-LABEL  MARKETING  RECS 

III  \S  1     1—  1  I  IS  1  \  1            Vw/  1     1       1  /  V  IS  l_  1       1  V 1 1  \  1  11  \  1       1  111  \S\    1  1 1  V/  V/ 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

i    i  /  /  v/  \w/ 1  v  1 1     i  /  v  '  l/  i  i  i/  > — /  ill   /  i — '  1 1  /  i  / 

FDA/OMPT/CDER/ORP/DIDP/ 

MORELLI  RATNER  PC 

2012-8285 

11/19/2012 
12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALEXANDER  FILATOV 
PARASCRIPT  LLC 

VUCOMP-  MULTIPLE  DIGITAL  MANNOGRAPHY  SYS 
P100005/S001  MANUAL,  LBLG,  SS&E 

2012-8286 

1 1/19/2012 

1     1  /    1  \JI  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

Kpvin  Koprnpr 

1  V t7  VIII    1  \             1  IUI 

DMF  2343 

L/ 1  v  1  1      £_  *_/   l  w 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Ineos  Barex 

2012-8287 

1 1/19/2012 

1     1  /     1   \JI  L—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  v  1  1          1    /   \  '  L/  1  1     1/   \w/  III       /    1  '   1  IS  1  / 

Sponn^oo  Park 

NDA019594  -  MEDICAL  RVW  CLINICAL  TRIALS 

1  M  IS  1  \  \J  1  *_/  -S  -^J    i         1  V 1  1  1 — /  1  > — /  J  \  1       1  IV  V  V  ,    \S  1—  1  1  *l  1  \S  i\  1—     1  1  I  1  /  1 1  \S 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DAEWOONG  AMERICA  INC 

2012-8288 

1 1/19/2012 

1     1  /    1  \J!  L—\J\L— 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  \S  1  1  1/  Vw/  III    /  1— /  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Kri^tan  Phillin^ 

1  \  1  1 0  LCI  1  1    1     1  1 1 1 1 1  k/O 

MacroGenics 

DR  YUNG-JUE  BANK  SEOUL  NATIONAL  UNIVERISTY 

\S  11     1  V/  1  *l  Vwi    <_J  V/  1        iS  I  \  1  *l  1  V  ,    U  1— —  \  '  V/  l_   1  *J  /  V  1  1  V_/  1  N  1  \  l_    V/  1  >J  1  v  1— —  III  V/  1  1 

HOSPITAL,  SEOUL,  KOREA  -  EIR,  483  05/27/2011 

2012-8289 

1 1/19/2012 

1     1  /    1  \JI  L—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

Annplia  Slavtnn 

i  \ i  iy \d 1 1 ex.  v/iuy  iui  i 

SBA  201739 

Vw/  IS  1  V  £_  V/  1  /  \J\J 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-8290 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Angelia  Slayton 

SBA  090358 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

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Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8291 

1 1/19/2012 

i  i  /  i  \Ji  t—\j\i— 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Annplia  filavtnn 

INC  RESEARCH  CONSULTING  & 

CI  IDrVIICCI/^MC 

oUdMIooIUIno 

K1 10753 

2012-8292 

1 1/19/2012 

1     1  /     1   \JI  L—\J\l— 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Annplia  PJavton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

K101612 

1  \    I   W    1   \J    1  L— 

2012-8293 

11/19/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Hannah  Cheng 

PIG  WHIPWORMS  -  SUBMISSIONS  PRIOR  TO  201 1 

12/17/2012 

ALFB/ 

MASSACHUSETTS  INSTITUTE  OF 
TECHNOLOGY 

2012-8294 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Mark  Wavrek 

ACCUTANE  - AERS 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Mark  Wavrek 

2012-8295 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Michelle  Nuez  /  David  Appleby,  Esq. 

INDIVIDUAL  RECS 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Hickey  Law  Firm 

12/17/2012 

rUA/UunUr/UH/VNt-rU/NYK- 

DO/NYK-DCB/ 

Debra  Sweitzer 

Kythera  Biopharmaceuticals,  Inc 

AM  HI,  HtlNootLAtH,  NY  -  tlH  (Ul/Ul  /tUUo  -  \  \  l\  OltL\j\  tL) 

2012-8297 

11/19/2012 
12/17/2012 

CVM/OCD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

NADA  97222,  NADA  1081 14  -  SUPPLEMENTS 

2012-8298 

11/19/2012 
12/17/2012 

CVM/OCD/ 

Algal  Scientific  Corporation 

GRAS  APPLICATIONS  FOR  YEAST  OR  MUSHROOM- 
DERIVED  BETA  GLUCAN  PRODUCTS  FOR  USE  AS  ANIMAL 
FEED 

2012-8299 

11/19/2012 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

Myron  Levin 

C  A  1  D\A/ A  DMIMP 

REVECOMED  INTERNATIONAL,  FULLERTON,  CA; 
ADVANCED  AESTHETIC  CONCEPTS,  FORT  WORTH,  TX  - 
EIR,  483,  WARNING  LETTER  (07/01/2012  -  11/16/2012) 

2012-8300 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Angelia  Slayton 

SBA  203214 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-8301 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Angelia  Slayton 

BLA  125276  S049 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

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Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8302 

11/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

RICHARD  KELLER 

AMERIGLIDE,  HANDICARE  ACCESIBILITY,  MAC  LIFTGATE 

12/17/2012 

BRUNO  INDEPENDANT  LIVING 

INC,  ETC  -  WHEELCHAIR  ELEVATORS  MARKETED  IN  THE 

AIDS 

US  NOT  COMPLYING  WITH  FOOD  DRUG  &  COSMETIC  ACT  & 

UU    1             1     V_/v_/IVll     l_  1   II  1VJ    VVI  1  1   1    1    Vw/  \w/  L-/    1  /  1  IUVJ    LX   WWOIVII       1  1  \J  1  \  v-/  1  t_X 

21  CFR  PART  800  TRADE  CMPLNT  INTERNAL  OR  EXTERNAL 

RECS,  CORR,  MAIL,  ETC 

2012-8303 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

THOMAS  CLUDERAY 

SUNSCREENS  -  CMPLNTS,  AERS,  CORR  1/08  TO  PRESENT 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ENVIRONMENTAL  WORKING 

FDA/OMPT/CDER/ORP/DIDP/ 

GROUP 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

2012-8304 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CHARLES  F JOHNS 

HYDROCODONE  -  FAERS  RPTS,  CMPLNTS, 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

STEPTOE  &  JOHNSON 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8305 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PATRICIA  BOGERT 

TRELSTAR  -  TRIPTORELINE  AERS 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

BOGERT,  PATRICIA 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8306 

11/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

KATE  PURCELL 

AUVI-Q  NDA  201  -739  -  SBA 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

DOCUTRIEVAL  INFORMATION 

FDA/OMPT/CDER/ORP/DIDP/ 

SERVICES 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8307 

11/19/2012 

FDA/OGROP/ORA/SE-FO/NOL- 

KYLE  SMITH 

NEEDLE  SPECIALTY  PRODUCTS  CORP,  BOYLE,  MS  -  EIR 

12/17/2012 

DO/NOL-CB/ 

NEEDLE  SPECIALTY  PRODUCTS 

07/07/09 

CORP 

2012-8308 

11/19/2012 

ORA/ORM/ 

KIM  C  CAPONE 

LIST  OF  ALL  INSP  PURSUANT  TO  THE  PRESCRIPTION 

12/17/2012 

ORA/ORM/ 

PORZIO  LIFE  SCIENCES 

DRUG  MARKETING  ACT  (PDMA)  1/07  TO  PRESENT 

2012-8309 

11/20/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

WAYNE  GAJADHAR 

ENTRY  NO  AMG-0093132-3  LAB  RPTS 

12/18/2012 

DO/FLA-CB/ 

TROPICAL  MARINE  LTD 

2012-8310 

11/20/2012 

FDA/OF/CFSAN/OCD/EOS/ 

WILLIAM  A.  OLSON,  Ph.D. 

NYLON  MXD-6  RESINS  (CAS  REGISTRY  NO  25718-70-1) 

12/18/2012 

Center  for  Regulatory  Services,  Inc. 

PETITIONS 

2012-8311 

11/20/2012 

ORA/ 

CLAUDIA  HORNBACK 

GOLDEN  STAR  WHOLESALE  INC  -  ENTRY  NO  G1 71 01 47845 

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Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

12/19/2012 

ORA/ 

n  / — \  a  n  i  /~\i/  i —  ~r"n  a  \~ \  i —  ni —  i — \  \  /  ■  ■ —  o  im 

ROANOKE  TRADE  SERVICES  INC 

i — \  i —  i —  i  i  o  a  i      r~t  i —  r~\  i —  i  i\  a —  n\ / 

REFUSAL,  REDELIVERY 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 

DO/DET-CB/ 

2012-8312 

1 1/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \l  \w/  1  v  1  1      1  /  \  '  L/  1  11   1/  V_/ \J  l__  1  1/  1  /  1    Vw/  1/ 

BRIAN  BELL 

U  1  1  11  VI  *J    1  }  \—  1  1  

TABLE  OF  MDRS  AND  PATIENT  PROBLEM  CODES  2006  TO 

1  I  1 1  1 1  1        Vw/  1      1  V 1  l—r  1  I V/  1  \  \  N  lw/    1     /  V  1  1  l_  INI     1     1  1  Vw/ 1— J  I  1  1  v  1    \J  Vw/  t — /       V/   t_  \J  \J  \J     1  V_/ 

1       /    1  \JI  L-\J  1  £_ 

BOSTON  SCIENTIFIC  CORP 

1  ' \J  w  1  Vw/  1  N    vJUM  IN  1  II     1  V/    V/  Vw/  1  11 

PRESENT 

2012-8313 

11/20/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

HIROHIKO  MURASE 

NSK  AMERICA  CORP,  HOFFMAN  ESTATES,  IL  -  K052700 

12/18/2012 

NSK  AMERICA  CORP 

2012-8314 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PABLO  PERHACS  JD,  PhD 

TEVA  PHARMACEUTICALS  -  PROPOFOL  INJECTABLE 

12/18/201? 

FnA/OMPT/nnFR/DRP/nmp/ 

i  vj  t\i  v_/ivi  \    \  1  \j  vj  \  rv     ill  /  vj  i i_/ 1  / 

^FARHY  HFNNFY  FT  Al 

O  1  f\  1  1  \J  I     VJ  \  1  N  1     1       I     1       1  l\\  

EMULSION  TESTING  &  ANALYSIS  2005  TO  2009 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

2012-8315 

1 1/20/2012 

1    1  /  i—  v//  i—  \J  1  J— 

FDA/OMPT/CDER/ORP/DIDP/ 

PABLO  PERHACS  JD  Ph  D 

1    I  \  \  '  \  V_/    1     1  1  1 1   11  V  Vw/  Vw/  .   VJ  L/    1     lla  L/ 

TEVA  PHARMACEUTICALS  -  PROPOFOL  INJECTABLE 

i  i     v  I  \  i    i  1 1  v  i  1 1  vinvj  i  v/  i  i  v_/ 1  \  \  i    ii  Vw/ 1   v/ 1  v/ 1      1 1  \u  i_ _  v/  i  /  \  i  >  \  i_ 

12/18/2012 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \_/  1— •*  1  1  1/  \J  III    /  L/  1 1  '  1  / 

SEARCY  DENNEY  ET  AL 

w  1  1  \  1  I V/  1     l_/  1  INIMI       1     1       1    1  \  1  

EMULSION  ANDA 

FDA/nMPT/nnFR/DRP/nmp/ 

n  vj  t\i  v_/ivi  n  i  /  o  i— /  r__  rv     i  \  i  /  i_/  i  vj  i  i 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8316 

11/20/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

PABLO  PERHACS  JD,  Ph.D. 

TEVA  PHARMACEUTICALS  -  PROPOFOL  INJECTABLE 

12/18/2012 

DO/PHI-CB/ 

SEARCY  DENNEY  ET  AL 

ri  ni  ii  oi am  rm    ^no    i~*f~\  ni —  on    ^r\nn  h  /r\ c  ~r/^\  nnrorMT 

EMULSION  EIR,  483,  CO  REbP,  CORR  1/05  TO  PREbENT 

rUA/OuKUr/UKA/rA-rU/LUb- 

DO/LOS-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  LJ  1  1  1/  Vw/  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8317 

1 1/20/2012 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    VJ  i  \i  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  \J  III    /  LJ  1  L/  1  / 

LAMICTAL  -  AERS  2007  TO  PRESENT 

1  1  \  1  V  1  1  V/   1  1  \  1             1  \  1  1   I \J    L—\J\JI       1  Vw/    1      1   11  \J  1  IN  1 

12/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

DISSELKAMP,  ROBERT  S 

FnA/DMPT/nriFR/nRP/ninp/ 

i  vj r\i  v_/ivi  i   \  1  \j vj  r__  n/  v/ 1 1 1  /  vj  i  vj i  i 

FDA/OMPT/CDER/ORP/DIDP/ 

o  a  -i  o  oo^ 
^01  ii-Oo1  O 

^  H  /OA  /OA  ^  o 

rUA/Ur/UrbAN/UGU/EUb/ 

JUMN  UUnbri  1  Y 

CnDTUAMC     UCr  flAD  1  IOI_l     CACTIM     CTP  ACDO 

rUn  1  HANb,  HblVIUHUon,  rAo  1  IN,  b  1  U  -  AbHb 

12/18/2012 

IOVATE  HEALTH  SCIENCES 

INTERNATIONAL  INC 

2012-8319 

11/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Angelia  Slayton 

BLA  125057  S0232 

12/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 

FDA/OMPT/CDER/ORP/DIDP/ 

SUBMISSIONS 

Page  1 1 9  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8320 

11/21/2012 
12/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALEXANDER  FILATOV 
PARASCRIPT  LLC 

ICAD  -  SECONDLOOK  CAD  SYS  P010038/S013  USER 
MANUAL,  LBLG,  SS&E 

2012-8321 

11/21/2012 
12/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALEXANDER  FILATOV 
PARASCRIPT  LLC 

VUCOMP  -  MULTIPLE  DIGITAL  MAMMOGRAPHY  SYS 
P100005/S001  USER  MANUAL,  LBLG,  SS&E 

i  h  /oi  /orn  o 
\  \  1  tL\  1  iL\j\  iL 

12/19/2012 

1  t—l    1  \JI  L—\J\S— 

rU/VUbnUr/Un/Vot-rU/rLA- 

DO/FLA-CB/ 

nAMAI  n  M  Ql  1  IC 

UUINALU  N  bLUt 

ZETETIC 

OnUOULA  1  to  -  tIN  1  hi Y  oMLUol  oo9o4A  rnU  1  UuHAbno, 

OASIS  SCREEN  SHOTS,  CBP  FORM  3461 

2012-8323 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

DONALD  N  BLUE 
ZETETIC 

ENTRY  D82-21 238636  -  PHOTOGRAPHS,  OASIS  SCREEN 
SHOTS,  CBP  FORM  3461 

Of*H  O  QO.O/1 
d\J\  drOOdA 

12/19/2012 

rUA/UMr  1  /UUnn/UUtn/UrUI/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  MtU  tlvlloUlN 

EMISON  HULLVERSON  LLP 

Un  IVML/MAtL  UAr\L,  o  1  ANrUriU  UNI V tnol  1  Y  -  UnnUNIU 

CEREBROSPINAL  VENOUS  INSUFFICIENCY  IN  THE  USA 
COMM,  INVESTIGATIONS,  RPTS,  ETC 

2012-8325 

11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

TOPOTECAN - AERS 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

VICINO,  WILLIAM 

2012-8326 


11/21/2012 
12/19/2012 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


DOMPERIDONE  -  AERS 


COX,  JAMES  E 


2012-8327 


11/21/2012 
12/19/2012 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 


CHARLES  SEIFE 

NEW  YORK  UNIV  ARTS  & 
SCIENCE 


FABRICATED  REC  IN  CLNCL  TRIALS  MUNNI 
SELAGAMSETTY  2/2/10,  GHANDI  SAADEH  12/08/08, 
HOWARD,  MARKER  4/28/08,  ETC  -  EIRS,  483S 


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Control  # 

Reed  Date  / 

UUc  LJdLc 

Action  Office 

Signature/  Requester 

Subject 

DO/BLT-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

2012-8328 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

KYLE  SMITH 

NEEDLE  SPECIALTY  PRODUCTS 
CORP 

NEEDLE  SPECILTY  PRODUCTS  CORP,  BOYLE,  MS  -  EIR 
7/07/09 

2012-8329 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

ONA SCANDURRA 
COUNTRY  LIFE  LLC 

RESPTO  483  1/10/12 

2012-8330 

11/21/2012 

ORA/ 

ANTONIO  MERCANTE 

CHOCOLATE  HAZELNUT  SPREAD  -  RESULTS 

12/19/2012 

ORA/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

DELIZIA  FOODS  INC 

2012-8331 

1 1/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/OGROP/OIP/ 

GARDINER  HARRIS 

I  \  1  1  1 — /  1  1  *l  l_  1  1    1   1 1  \  1  1 1  1 1  \J 

NEW  YORK  TIMES 

SPICE  FARMS  INDIA  -  PROFILE  RECS  NOTES 

Vw/  1       1  Vw/  1—     1     1    \  1    1 1  V  1  W  j     1  1  M  \—s  1  /    V           1       11  Vw/  1      1  1  1           1    I  l__  > — /  K-f  ,     1   *J  \w/    1    1—  K-f  , 

SUMMARIES,  WARNING  LTRS,  ETC 

2012-8332 

11/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

KRISTI  0  SMEDLEY 

Center  for  Regulatory  Services,  Inc. 

MONSANTO  -  ETHOXYQUIN  FAP  00001 

2012-8333 

11/21/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

JOHN  CREWDSON 

ZOSTAVAX  -  VAERS 

12/19/2012 

ALFB/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

2012-8334 

^  h  /oh  o 

1 1/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Merle  Zimmermann 

AMERICAN  HERBAL  PRODUCTS 
ASSOCIATION 

MrpTi  1 —  1  io  A     l/n  A  ITT  ITAARO      1  r  n  OH/II                              ^  A  1 —  r~>  O 

NESTLE  USA,  KRAFT  FOODS,  JM  SMUCKERS  -  CAERS 
(11/01/2010-  10/31/2012) 

2012-8335 

A  H  /OH  /OOH  O 

1 1/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Merle  Zimmermann 

r~\ /~\ o  a  /~» /~\ i  a      /™v it  « n  a  n i\/   n  i —  no  i/~»/-\         a  i —  no  / h  h  /o h  /oo h  h 

COCA  COLA  COMPANY,  PEPSICO  -  CAERS  (1 1/01/201 1  - 

12/19/2012 

AMERICAN  HERBAL  PRODUCTS 
ASSOCIATION 

10/31/2012) 

2012-8336 

11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Patrick  Moriarty 

RELISTOR  -  AERS;  FOIA  REQUESTS 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1 V  1  1      1  /  \w/  L/  1  1  1/        III    /  I — '  1  L*/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/DFOI/ 

HEALTHCOR  MANAGEMENT  LP 

1   1  l—  l  \  L_  1  1   1  w  \S  11    1 V  1 1  V 1  4 1  \  K-A  1—  1  v  1  1  1       1     1  1 

2012-8337 

11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Gary  J.  McGarity 

LUNESTA- AERS 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Gary  J.  McGarity,  PharmD 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8338 

11/21/2012 

FDA/OMPT/CBER/OCOD/DDOIW 

Christine  Ringler 

INDIVIDUAL  RECS 

12/19/2012 

ALFB/ 

Esdaile,  Barrett,  Jacobs  &  Mone 

2012-8339 

11/21/2012 
12/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Valerie  Franck 

STRYKER  INSTRUMENTS 

K081047 

2012-8340 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

Andrew  Han 
VISIUM  FUNDS 

INVACARE,  ELYRIA,  OH  -  483  (01/01/2012  -  12/19/2012) 

12/19/2012 

rUA/UMr  I  /OUtrl/Urir/UIUrV 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

John  Lewis 
ACROMED  CORP 

CUfMA/              I"1!  IMI^AI    TDIAI  DADTIPIDAMTC 

onUVV  rUn  OLINIOAL  1  KIAL  rAH  1  lUlrAN  1  b  - 

INVESTIGATION  RECS 

2012-8342 

11/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Michelle  R.  Minton 

The  Competitive  Enterprise  Institute 

GORTON'S  CRUNCHY  BREADED  FISH  STICKS,  GENERAL 
FOODS  POP  ROCKS,  HERSHEY'S  PAYDAY,  ETC  -  CAERS 
(Ul/Ul/1  U-U1/U1/1  d.) 

2012-8343 

11/21/2012 

FDA/OGROP/ORA/CE-FO/DET- 
DO/DET-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ross  Brooks 
oanToro  neisier,  i_i_r 

DEPUY  ORTHOPAEDICS,  INC  ASR  XL  ACETABULAR  HIP- 
REPLACEMENT  SYSTEM  -  COMMUNICATIONS  BETWEEN 
FDA  AND  DEPUY  (1 0/07  TO  10/11) 

2012-8344 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OF/CFSAN/OCD/EOS/ 

Mary  Clare  Jalonick 

THE  ASSOCIATED  PRESS 

MARTE  RICOTTA  SALATA  FRESCOLINA  CHEESE  -  RECALL 
RECS,  INSPECTIONS 

2012-8345 

11/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

John  Shoemaker 
Visium 

5  HOUR  ENERGY  -  ADVERTISING  INQUIRY 

2012-8346 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/CE-FO/DET- 

UU/Ut  I  -L>b/ 

Tyler  Kenyon 

NORTHCOAST  RESEARCH 

STRYKER  INSTRUMENTS,  PORTAGE,  Ml  -  483  (6/18/2012); 

o  I  r(YI\bri  IVItUIUAL  Ul  VIolUN  Ur  o  I  riYI\bri  L/UrlrUriA  I  IUIn, 

PORTAGE,  Ml  -  483  (6/26/2012);  STRYKER  INSTRUMENTS, 
PORTAGE,  Ml  -  483  (11/09/2012) 

2012-8347 

11/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Julie  Myers 

G.D.  SEALE  &  COMPANY  ORAL  CONTRACEPTIVE  - 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Columbia  University  Medical  Center 

PACKAGE  INSERT  (1970) 

2012-8348 

11/21/2012 
12/19/2012 

F  D  A/OG  ROP/O  R  A/C  E-  FO/B  LT- 
DO/BLT-CB/ 

FDA/OC/OES/DFOI/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

COMPLAINT  RECS 

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Total  Records:  9990 


V_/UI  III Ul  tt 

Due  Date 

MO  LIU  1 1  WIMOti 

QinnQtiiro/  R0/-11  loctoi* 

oiyiidiuit;/  ncmjcoici 

OUUJtfOl 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

V_/ 1  1  / v  v_/  V_/ 1  / 

ORA/OCI/ 

2012-8349 

11/21/2012 
12/19/2012 

FDA/OC/OES/DFOI/ 

Benjamin  Lesser 
Benjamin  Lesser 

ENERGY  DRINKS  ADVERSE  EVENTS  -  FOIA  REQUESTS 
M  1/01/2011  -  11/20/20121 

2012-8350 

1 1/21/2012 
12/19/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Merle  Zimmermann 

AMERICAN  HERBAL  PRODUCTS 
ASSOCIATION 

COFFEE  BEVERAGEb  AND  CAFFEINE  PRODUCTS  -  CAERS 
(11/1/2010  TO  10/31/2012) 

2012-8351 

1 1/21/2012 

1    1  /  £_  1  /  £_  W  1  i— 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  V- /  III    /  L/  1  L/  1  / 

Mahidhar  Hhintp 

IVIdl  1 IVJ  1  1  O.I    Vw/ 1  III  1  LCI 

EFAVIRENZ  LAMIVUDINE  TENOFOVIR  DISOPROXIL 

1  1    n  V  II  1 1  1  N  i—  .    1  /  V 1  v  1 1  V  VJ  l_/  1 1  M  1  ,     1  1  n  Vw/  1    v_/  VIII  1— /  1  V/  Vw/  1    1  I  Vw/  /  \  1 1  

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MICRO  LABS  USA  INC 

FUMARATE-  SBA 

2012-8352 

11/21/2012 
12/19/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

F  D  A/OG  ROP/O  R  A/S  W-  FO/D  AL- 
DO/DAL-CB/ 

Tyler  Kenyon 

NORTHCOAST  RESEARCH 

NORLAND,  FORT  ATKINSON,  Wl  -  483  (7/30/2012); 
COOPERSURGICAL,  STAFFORD,  TX  -  483  (8/06/2012) 

2012-8353 

1 1/21/2012 
12/19/2012 

FDA/OGROP/ORA/CE-FO/DET- 

1    1  /  /  V/  Vw/  \J  1  1  Vw/  1    /  Vw/  1  1/  V/  \J  l__    1    Vw//  L/  1   1 

DO/DET-CB/ 

.lanp  M  Ha^tpdt 

w  CI  1  1  \j    Ivl.    1  luOlv^Ul 

G  C  HANFORD  MFG  CO 

DOW  CORNING  HEALTHCARE  INDUSTRIAL  MATERIALS 

i  /  Vw/  v  v  v/  Vw/ 1  1 1  m  1 1  n  \w/  i  1 1—  /  \  i—  i  i  i  v/ni  1 1— _  1 1  ii  iw/  v/  v/  ill  i/  v  i_  i  v  i  /  \  i  i_  i  1 1  /  v  i_  v/ 

SITE,  HEMLOCK,  Ml  -  EIR,  483  (05/01/2012  -  05/31/2012) 

2012-8354 

1 1/21/2012 
12/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  11   1/  V»/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

Sfpnhpn  Innlp^p 
Sleep  Group  Solutions 

K011329  K921452 

1  \U    1      1  Vw»  L—  \J  1     1  \|/U    1      1^  \w*  L_ 

2012-8355 

1 1/21/2012 
12/19/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  l__  1  1/  1  /  1    Vw/  1/ 

Dari  Darahhpini 

Persyst  Development  Corporation 

K092625 

2012-8356 

1 1/23/2012 

1     i  1  L—  \JI  C—\J\L— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

Vpr^ahond  AR  Ronp  Opmpnt 

V  \j  1  O  Clks \J  1  1  V-J   /  V I  >    1  } V/  1  1  \j    Vw/  V_-  1  1  1  V_-  1  1  L 

K022688 

12/21/2012 

FDA/OC/OES/DFOI/ 

Laboratories  SL  S.A. 

2012-8357 

1 1/23/2012 
12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    1  /  /  V/  Vw/  1    /  V/  1    V/  /  V 1  M/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

Kpvin  1  C-ioldhprn 

1  V  V^  VIII    la    Vw/  V/ 1 V/  UUI  V_J 

Goldberg,  Finnegan  &  Mester,  LLC 

MONSTER  ENERGY  DRINKS  -  FULL  ADVERSE  EVENT 

1 V  1  Vw/  1  M  V/  1  1— —  1  1    1  1  N  1  1  1  Vw/   1      L/  1   II  1  VI  |  V  V/        1    V/  1  1       /  \  L/  V  1  1  \\J  \        l_  V  1— —  1  M  1 

REPORTS  (01/01/2004  -  10/23/2012) 

2012-8358 

11/23/2012 
12/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Versabond  AB  Bone  Cement 
Laboratorios  SL  S.A. 

K022688 

2012-8359 

1 1/23/2012 

1     1  /  t—\JI  L—\J\C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

Amhpr  Mvnakha 

I  \  1  1  1  k/ 17  1     1  V  1  y  1  1  Ct  1 V 1  1  CI 

DAPTOMYCIN  -  AERS  (01/01/2003  -  11/01/20121 

1  >  1  \\      1  Vw/ 1 V  1   1  V/  1  1  V        1  V l_  1  I V/    \  V/  1  /  \J  11  L—  V/  v/ V_J          1    1  /  V/  1  /  £_  V/  1  L_  J 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Northeast  Regional  Medical  Center 

2012-8360 

11/23/2012 

ORA/ORM/ 

David  Mangione 

LISTOF483S  ISSUED  08/29/2012  TO  1 1/21/2012 

12/21/2012 

ORA/ORM/ 

Govzilla,  Inc. 

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Subject 

2012-8361 

11/23/2012 

ORA/ 

William  Figueroa 

594-0230269-5  -  COLLECTION  REPORT,  ANALYST 

12/21/2012 

ORA/ 

Southwind  Foods  LLC  DBA  Great 
American  S 

WORKSHEET 

20 1 2.-8302. 

^  H  /OO  /OA  ^  o 

1  \l2il20\2 
12/21/2012 

rUA/UIVlr  I  /O  I  r/UU/ 

Hagens  Berman  Sobol  Shapiro  LLP 

HAGENS  BERMAN  SOBOL 
SHAPIRO  LLP 

1  OBAOOU  HKUUUC  1  MANUrAG  1  UKtKb,  IMPUK  1  tKb, 
AGENTS  -  REPORTS  SUBMITTED  2012 

2012-8363 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L_/  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

Adrian  Chpw 

FDA  INACTIVE  INGREDIENT  GUIDE  (1993} 

1  1 — '  1  \    1  1  N 1  \ Vw/  1  1  V  1—    II  il  Vwi  1  1 1_  IS  1  1  INI     Vwi  \S  1  \S  1        I    1  \J\J\J  1 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Pinsent  Masons 

2012-8364 

11/23/2012 
12/21/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Michael  Pan 
Michael  Pan 

K1 22260 

2012-8365 

11/23/2012 
12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

F  D  A/OG  ROP/O  RA/P  A-  FO/S  E  A- 
DO/SEA-CB/ 

SHELDON  T.  BRADSHAW 
HUNTON  &  WILLIAMS  LLP 

AVID  HEATLH  INC;  NORTHWEST  NATURAL  PRODUCTS  INC; 
SUPPLEMENT  SCIENCES  INC  VANCOUVER  WA  -  EIR  483 

<s vj  i   i   i  i  i  vi  i  w  i          1 1  i   Vw/ 1  v  '  1 1  >j  v_/ ,   v  ni  ni  \j  \s?  Vw/  vi  iii  v  v  i \       i  1 1  i .  tuJ) 

RECALL  11/20/10  TO  PRESENT 

2012-8366 

11/23/2012 
12/21/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

IS  \  '    /  V  1  E       Vh/  \S ! 

Lesley  Valle 
Boehringer  Ingelheim 

RODOLFO  BORDONI,  MARRIETTA,  GA  -  483  (08/28/95) 

2012-8367 

1 1/23/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

John  Crewdson 

ZOSTAVAX  -  ACTION  PACKAGE 

12/21/2012 

ALFB/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

2012-8368 

11/23/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

David  Dortch 

PLEXUS,  BAYAN  LEPAS,  MALAYSIA  (01/01/2012  -  11/01/2012) 

12/21/2012 

QIAGEN  SCIENCES 

-  EIR 

2012-8369 

1 1/23/2012 

1     1  /  t—\JI  L—\J\S— 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \S  1 V  1  1      11  \  '  IS  1  1  1/  \S  III    /  1 — '  1  l  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  1  1  1/  W  III    /  \S  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Cuhi^t  Pharmarputirpite 

VJUUIOl    1     1  IUI  1  1  lUUUUlluUlO 

Cubist  Pharmaceuticals 

DAPTOMYCIN  -  RPTS  FOR  CASES  OF  EOSINOPHILIC 

\S  1  VI      1  Vw/ 1  v  1   1  Vw/  1  1  V        III      1  K-f    1    Vw/  1  I  i — /  /  \  \_J  l_  \S   Vw/  1       l_  Vw /  \S  1  1  N  Vw/  1     1    1  1  L_  1  \S 

PNEUMONIA  (01/01/2004  -  12/31/2010) 

2012-8370 

1 1/23/2012 

1     1  /  L—\JI  L—\J\C— 

12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  \s  1    /  \S  1    *S  J  \  \  Hi  \S  Vw/  IS f  I—  \s  *s/ 

.In^pnh  Wilson 

UUOUUI  1    VVIIOUI  1 

joe  wilson 

MOUNTAIN  DEW  -  CAERS  (01/01/2000  -  1 1/21/20121 

1 V  1  Vw/  Vw/  1  M  1  1  V 1  1  *J    IS  l_  V  V         Vw/  /  V  l_  1  I  w    1  \J  1  /  V/  1  /  L—  \J  \J  \J          1    1  /  £_  1  /  L—  \J  1  L_  1 

2012-8371 

11/23/2012 
12/21/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

William  McPhail 
Woodard  &  Curran 

EVERGREEN  ORCHARD  FARM,  HAMILTON,  NJ  -  EIR 
ATTACHMENTS  (03/22/12) 

2012-8372 

1 1/23/2012 

1     1  /  £ —  V//  L —  V/    1  L — 

FDA/OMPT/CDER/ORP/DIDP/ 

Amber  Mynakha 

NOVOLOG,  LANTUS  -  AERS  (01/01/2000  -  1 1/01/2012) 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Northeast  Regional  Medical  Center 

Page  1 24  of  895 


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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8373 

11/23/2012 
12/21/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DOUGLAS  N.  BLUE,  II 
ZETETIC 

BAUSCH  &  LOMB  -  34  BUNDLES  CONTAINING  OTC  ENTRY 
NO  51620481492 

2012-8374 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

Mahidhar  Ohinta 

1  v  1  d  1  1 1  \A  1  lUl     Vw/  1  1 1 1  1  LCI 

NDA  203076  -  SBA 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MICRO  LABS  USA  INC 

2012-8375 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  1 — /  I  J  /  I  / 

Mahidhar  Ohinta 

1  v  1  d  1  1 1  \A  1  1  CI  1     Vw/ 1  1 1 1  1  LCI 

NDA  021971  -  SBA 

1  N  1—/ 1  \  Ul.  1  h/(    1         V/ 1  it  \ 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MICRO  LABS  USA  INC 

2012-8376 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

Mahidhar  Ohinta 

1  v  1  CI  1  1 1  \A  1  1 CLI    Vw/ 1  1 1 1  1  LCI 

NDA  022461  -  SBA 

1  *J  I — /  /  V  v/  £_  £_     v/  1         *w/  !  '  1  \ 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MICRO  LABS  USA  INC 

2012-8377 

L_ \_/  1  £_    V*JvJ  /  / 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

CIPRO  -  AER 

Vw/  1  1        1     1  Vw/              /     \  1         1  i 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MATHERNE,  MICHAEL  MARK 

2012-8378 

11/23/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Alec  White 

STARBUCKS  -  ADVERSE  EVENTS,  CONSUMER 

12/21/2012 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

HEALTHCOR  MANAGEMENT  LP 

COMPLAINTS 

V/  Vw/  1 V  1  1     l_/  V  1  1  M  1  V/ 

2012-8379 

11/23/2012 
12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Alec  White 

HEALTHCOR  MANAGEMENT  LP 

TEAVANA  -  CONSUMER  COMPLAINTS,  ADVERSE  EVENTS, 
STUDEIS  RE  POTENTIAL  PESTICIDE  CONTAMINATION 

2012-8380 

1 1/23/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  l_/  1  1  1/  V_/  III    /  ( — '  1  J  /  1  / 

Mahidhar  Ohinta 

1  v  1  CI  1  1 1  \A  1  1  CLI    Vw/ 1  1 1 1  1  LCI 

NDA  022459  -  SBA 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  \—/  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

MICRO  LABS  USA  INC 

2012-8381 

11/23/2012 
12/21/2012 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

James  Hurley 
HURLEY,  JAMES 

VEGETABLE  JUICES,  INC,  BEDFORD  PARK,  IL  -  483, 
COMPANY  RESPONSE,  EIR  (03/01/2012  -  1 1/20/2012) 

2012-8382 

1 1/23/2012 

1     1  /  C—\Jl  L—\J\S— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/ 1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

MICHELE  L  BUENAFE 

1  v  1 1  w  1  1 1—  1  1       1  ■    I—/  V/  1—  1  *J  1  V  l  l__ 

SANTYL  fCOLLAGENASE^  APRVL  LBLG  CO  RESP 

Vw/  /  VI  Ml     1   1       I  \w/  Vw/  1_  l_/ \  \Si  1  1  V|  /  V  Vw/  1      1   / \  1     1  I  V  Li  ■    1—  1  )  L-  Vw4  ,    V/  V/    |  1 1__  I 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MORGAN  LEWIS 

Page  125  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8383 

11/23/2012 
12/21/2012 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

F  D  A/OG  ROP/O  RA/P  A-  FO/S  AN  - 
DO/SAN-CB/ 

CooperVision,  Inc. 
CooperVision,  Inc. 

COOPERVISION,  PLEASANTON,  CA  -  483  (0  5/17/2012); 
COOPERVISION,  W  HENRIETTA,  NY  -  483  (05/29/12) 

2012-8384 

1 1/23/2012 

1     i  1  L—  \JI  t—  \J  1  C— 

12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  w  1    Vw^  1  V 1  N/  Vw/  Vw/  1 — /  /  l_  Vw/  V_// 

Shailini  Rao 

1  IClllll  II    1  LQU 

Eton  Patrk  Capital  Management 

STARBUCKS  - AERS 

*S  1  I  \  1   IUUV/1  \U        l  \  1  1  \\J 

2012-8385 

1 1/23/2012 
12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Sontakay,  Suresh 

FOOD  CONTACT  SUBSTANCE  15  4/00 

1    Vw/  Vw/  IS    V/  Vw/  1  >J   1  /  V  w  1     yS  V/  IS \J  1  1  V 1  M  \J  l_     1  v/      i  /  w  V/ 

2012-8386 

1 1/23/2012 

1     i  1  L—  \JI  C—\J\L— 

12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  \S  1    0 1  \  1  >!/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Sontakay,  Suresh 

FOOD  CONTACT  SUBSTANCE  685  3/20/07 

1    Vw/  Vw/  lw/    V/  Vw/ 1  *J  1  /  VV/  1     \S  \S  IS  \s  1  1  \  1  M  V_/  L        vUU   O    L_  w    V/  / 

2012-8387 

11/23/2012 
12/21/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Sontakay,  Suresh 

FOOD  CONTACT  SUBSTANCE  889  7/3/09 

2012-8388 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  10/29/12-11/2/12 

o/~n  o  ooon 

<?01<;-8o89 

12/24/2012 

rUA/OO/Utb/UhOI/ 

KtN  KtlU 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  11/5-9/12 

2012-8390 

C—  V/  1  C—  \J\J\J\J 

1 1/26/2012 

1     1  /  C—\Jl  L—\J\S— 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V_J  1  \     1  t  \  1  11  11  *S  \s  1  N    <S  Vw/  1   1  1  1 1  \  1  v  1  1 

CLOSED  FOIA  REQUESTS  11/12-16/12 

\JLV/U  1  L/    1    Vw/  1  /  \    1  1 1— —       \S>  1  V/  1  V/     1    1  /    1  £_     1  \J/  1 

12/24/2012 

FDA/OC/OES/DFOI/ 

CanReg,  Inc. 

2012-8391 

t—\J   1  L—    \J\JsJ  1 

1 1/26/2012 

1     1  /  l—  \JI  L—\J\t— 

FDA/OC/OES/DFOI/ 

1    L/ 1  \!  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V_J  1  \     1  t  \  III  11  \J  \S  1  N         Vw/  1   1  1  I  /  \  1  V 1  1 

CLOSED  FOIA  REQUESTS  11/5-9/12 

Vw/  l_  Vw/  Vw/  1  (_/    1     V-/  1  /   V    1    l  1— —  \_K  *S  1  VwJ   1   U      1     1  /  \J    \J1    1  L_ 

12/24/2012 

FDA/OC/OES/DFOI/ 

CanReg,  Inc. 

2012-8392 

1 1/26/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \     1  1  1 1  1 1  1 1  \S  V_/  1  v    \s  Vw/  1   1  1  1 1  \  1  V  1  1 

CLOSED  FOIA  REQUESTS  10/29/12-11/2/12 

Vw/  l— Vw/  Vw/  1  1  J     1     Vw/  1  /   \    1    1  1— —         \S>  1  V/   1  V/      1  V/  L_  *_//    1  L—      1     \  1  ^1    1  L_ 

12/24/2012 

FDA/OC/OES/DFOI/ 

CanReg,  Inc. 

2012-8393 

1 1/26/2012 

1     i  1  L—  \JI  L—\J\L— 

12/24/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  'Six     1  /  \  1  11  11  \S  V-/  1  i|    \S \J  1   1 1  1 1  \  \  V 1 1 

CanReg,  Inc. 

FOI  DAILY  LOG  10/29/12-11/2/12 

1    Vw/  1  1 — '  1  VI  1       1     1  \S  \S     IV//              1  L-      1    1  /  ^/    1  L_ 

2012-8394 

1 1/26/2012 

1     1  /  C—\Jl  L—\J\C— 

12/24/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \     \  1  \  1  1 1  1 1  \S  \S  1  >l    \s  Vw/  1   1  1  1 1  \  1  V 1  1 

CanReg,  Inc. 

FOI  DAILY  LOG  11/5-9/12 

1    Vw/  1  1 — '  1  \  \  \       1     1  \S  ^S     1    11  \J    \J1    1  L_ 

2012-8395 

1 1/26/2012 

1     1  /  L—  \JI  L—\J\t— 

12/24/2012 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

BARBARA  JONES 

IS  I  \  \  l  IS  I  \  J  1 1  \  \j  Vw/  1  *J  1  ^s 

DOMINION  GROUP  INC 

FOI  DAILY  LOG  10/29/12-11/2/12 

1    Vw/  1    \S  1  VI  1       1     L_  Vw/  V^l     IV//  L—  \J  1    1  £_     1    1  /  ^/    1  L_ 

2012-8396 

1 1/26/2012 

1     11  £ —  V//  L —  \J    1  L — 

12/24/2012 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

FOI  DAILY  LOG  11/5-9/12 

2012-8397 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

GLADYS  B  TONKIN 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  10/29/12-1 1/2/12 

Page  126  of  895 


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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8398 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

GLADYS  B  TONKIN 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  11/5-9/12 

2012-8399 

11/26/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

CLOSED  FOIA  REQUESTS  1 1/1 2/-1 6/1 2 

12/24/2012 

FDA/OC/OES/DFOI/ 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

OAHO   C\  A  C\C\ 

2012-8400 

1 1/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

nrni  O  f~\  1  II —  K  I 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOIA  REQUESTS  11/5-9/12 

2012-8401 

1 1/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  L-/  I  / 

REO  TANOSHIMA  MD 

1  1 1—  Vw/     1  /  VI  VJ  Vw/  O  1   III  VI/  V   1  v  1  L/ 

COPAXONE  - AERS 

Vw/  Vw/  1    /  V  /  V  V_/  1  M  l_        1  \  1  1  IVJ 

12/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L_/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

HOSPITAL  FOR  SICK  CHILDREN 

2012-8402 

11/26/2012 

FDA/OC/OES/DFOI/ 

DIETARY  SUPPLEMENTS  RECALLED  DUE  TO  IMPROPER 

12/24/2012 

DAYTON, KATHRYN 

LBLG 

2012-8403 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOIA  REQUESTS  10/29/12-11/2/12 

2012-8404 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  10/27/12-11/2/12 

2012-8405 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  11/5-9/12 

2012-8406 

i—  \J    1  L—     V/    I  \J  \J 

1 1/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

1    L/  1  \l  WW/  Vw/  1 —  \JI  1— /  1    VwX  1/ 

DAVID  MCFARLAND 

1  s  1  \  V  1  1  /    1  v  1  Vm/  1    t  \  1  I  I—/ \  1  *l  1 — / 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  11/12-16/12 

Vw*  l_  Vw/  *w/  1  1  /     |      Vw/  1  /    \     1    I  1— —  \J  K-)  1  Vw/    |    Vw/       1     1  /     1  £—       1  V//     1  £— 

2012-8407 

1 1/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

i    i—ti\i  Vw/  Vw//  Vw/ 1 —  vj/  i— /  i  Vw/ 1/ 

DAVID  MCFARLAND 

1  J  1  \  V  1  1 — /    1  v  1  Vm/  1    / x  1  1 1  1  \  1  VI  1 — ' 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  10/29/12-11/2/12 

Vw/ 1— Vw/  Vw/  1  1 — ^    1    V_/  1  /  V   1  1 1__  V_x  \-)  1  U  1  U     IV//              \  t—      \    lit—/    1  L_ 

2012-8408 

1 1/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

1  1— '  *V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J  1  \  V  1  1  /    1  v  1  Vw /  1    /  \  1  1 1  /  \  1  *l  1 — / 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  11/5-9/12 

Vw/  l— Vw/  Vw/  1         1  S       |       \  '   |  1    V      |     I  l__  V_X  Vw^  1         Vw/     1    Vw/        I       1    /   \_/             /      i  l 

2012-8409 

L—\J    1  t—    v/    i  V/  \J 

1 1/26/2012 

1     i  1  L—  \JI  C—\J\L— 

12/24/2012 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

1  / \  V_/  1  l  1  1  VI    Vw/    L_J  /  V 1  11  I 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REQUESTS  11/5-9/12 

Vw/ 1_  Vw/  Vw/  1  1 — ^    1    V_/  |  /  \   |  1 1__  V_x       1  U  1  VwJ     1    1  /  \w*    \J1    1  L_ 

2012-8410 

1 1/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REQUESTS  10/29/12-11/2/12 

2012-8411 

11/26/2012 
12/24/2012 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

CLOSED  FOIA  REQUESTS  1 1/12-16/12 

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Control  # 

Reed  Date  / 

Action  Office 

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Subject 

Due  Date 

2012-8412 

1 1/26/2012 

FDA/OC/OES/DFOI/ 

CLOSED  FOIA  REOUESTS  10/29/12-11/2/12 

Vw/ 1  V/  O  1  , !_/   1    v_/  1  /  \  I  1 1  VjIU  1  VJ  1  w    1  \J!  C-\JI  \  C—     \    II  L—l   1  C— 

12/24/2012 

FOI  Services,  Inc. 

2012-8413 

1 1/26/2012 

1     i  1  L—  \JI  t—  \J  1  C— 

FDA/OC/OES/DFOI/ 

CLOSED  FOIA  REQUESTS  11/5-9/12 

>  '  1  ' — /  \  >  1  L_/    1           1  /  V   1  1 1   — J   '  1  •  '  1  •  '     1    11  \J    \JI    1  £_ 

1  t—l  C—^l  L—\J\C— 

FOI  Rprvipp^  Inr 

Of~\  -1  O  O  A-i  A 

11/26/2012 

ORA/OCI/ 

KAREN  C  KOSKI 

ABIUMEU  -  bUBrUENA  lU/^b/1^  KEOo 

12/24/2012 

ORA/OCI/ 

LAZARD  CAPITAL  MARKETS 

2012-8415 

11/26/2012 

FDA/OC/OES/DFOI/ 

THEO  EMISON 

DR  MICHAEL  DRAKE,  STANFORD  UNIV  -  DIAGNOSIS 

12/24/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

EMISON  HULLVERSON  LLP 

AND/OR  TREATMENT  OF  CHRONIC  CEREBROSPINAL 

VENOUS  INSUFFICIENCY  (CCSVI)  CORR,  RPTS, 

INVFc?TlfiATir)Nc?  FTH 

1 1  NJ  V  1  O  1  1  vj f  \  1  IUI  MO,   I—  1  V_/ 

2012-8416 

C\J  I  C    Ot  1  \J 

1 1/26/201? 

FDA/DMPT/nnRH/nnFR/nFm/ 

MFfiANI  9TORRIF 

1 V 1 1  Vj  A\  1  >J  O  1  v_/ 1  1 1  ill  

INDIVIDI IAI  RFH^  -  MAI  IDF  RPT 

1 1  N  VJ  1  V  1  L/  \J r\ L_  1  1 1  v_/  v_>      IVlrAU  \—J  1   nil 

12/24/2012 

MELLINO  ROBENALT  LLC 

2012-8417 

1 1/26/2012 

FDA/OGROP/ORA/CE-FO/CIN- 

GABRIEL  F  ZAMBRANO 

n  i —  u  n  i  iv,      i~  n  \w  i/^  1 —  i  i  1 1 —  i  r  a  nuAnuA  /™*  mdu  o      f~\     n  n  a  nv  a  \/  a 

BOEHRINGER  INGELHEIM  PHARMA  GMBH  &  CO  -  PRADAXA 

12/24/2012 

DO/CIN-CB/ 

i —  a  n r  a i —  n   i  a  i —  i —  i —  ia/itiooim 

FARMER  JAFFE  WEISSING 

CAPS  (DEBIGATRAN  ETEXILATE)  NDA  22-512  RECALL 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  1— /  1  ]  /  1  / 

EDWARDS  FISTOS  &  LEHRMAN 

l__  L/  V  V  1  \  \  1 1  /  Vw/    1    1  Vw/  1  Vw/  Vw/   t_X    1_  I  |   I  I  11  VI/  VI  M 

RECS 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  / V/  Vw/ 1 V  1 1      1  /  V/  !_/  1  1  1/  V_/  III    /  [_/  1  L/  1  / 

PL 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8418 

1 1/26/2012 

FDA/OF/CFSAN/OOD/EOS/ 

i— \  a  \  / 1  nv  \  a/  ni  i  ini iy — r   in   \w  a 

DAVID  W  PLUNKETT  JD  JM 

\  / 1 n n i r~\  \  /i  ii  niiit'i^,,i  io  nioi/      a  i      i  1 1  a ~\~ f~\ n     r  a ^ ^  a /^v o       ^  ji  a  i i  o 

VIBRIO  VULNIFICUS  RISK  CALCULATOR  -  MEMOS,  EMAILS, 

12/24/2012 

CENTER  FOR  SCIENCE  IN 

TRANS  ETC  2007  TO  PRESENT 

i  i  irvi  »*—/,  i     i  \j  L—\j\ji    i  Vw/  i   i  ii  \_j  \  i  vi  i 

PUBLIC  INTEREST 

2012-8419 

1 1/26/2012 

1    1  /  £_ V//  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

JOHN  BLOCH 

VJ  W  1   1  1  VI    l  >  Lw  Vw/  1  1 

LORAZEPAM  INTENSOL  -  ANDA  RECS 

i_  Vw/  |   1/  \ L  1  1    t  VI V  1    Mil  1  1  vV/V/  1            /  \  1  VI  l_>  /  V    1  1 1  V/  Vw/ 

12/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JOHNS  HOPKINS  MEDICINE 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  L/  1  L/  1  / 

DEPT  OF  NEUROLOGY 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8420 

11/26/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CHRISTOPHER  HENDEL 

ENERGY  DRNKS  -  CAERS  4/12/12  TO  PRESENT 

12/24/2012 

CONSUMERS  UNION  OF  THE 

U.S.,  INC 

2012-8421 

11/26/2012 

FDA/OC/OES/DFOI/ 

David  Mangione 

PFIZER,  PEARL  RIVER,  NY;  HOSPIRA,  ROCKY  MOUNT,  NC; 

02/01/2013 

FDA/OGROP/ORA/SE-FO/ATL- 

FDAZILLA 

f\  a  ~T  A  1  | —  K  |~r  0/-\|   I  ITIAMP     nri  Oil  IK  A  ACfi 

CATALENT  SOLUTIONS,  BELGIUM  -  483 

DO/ATL-OB/ 

FDA/OMPT/CBER/OOOD/DDOM/ 

ALFB/ 

ORA/ 

ORA/ 

FDA/OGROP/ORA/NE-FO/NYK- 

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Action  Office 

Signature/  Requester 

Subject 

DO/NYK-DCB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-GB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L_/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/DFOI/ 

2012-8422 

1 1/26/2012 

1    1  /  C—\Jl  t—\J  1  t_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L_/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

GJ  MrGaritv 

IVIV^VwtCll  1  L  y 

LYRICA  -  AERS 

1       1   1  LlVuS/%        t  \  1  1  l\J 

12/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

GJ  McGarity 

2012-8423 

11/26/2012 
12/24/2012 

OM/OMP/DODM/ 

ronald  piana 
Ronald  Piana 

ADVISORY  COMMITTEE  MEETING  MINUTES  -  HYBRITECH 

INC  (06/29/93^ 

2x>\2.-ii'\2.'\ 

1 1/26/2012 
12/24/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Maryalice  Gill 

The  Telegraph  of  Nashua,  NH 

SMARTPHONE  APPb  -  COMPLAINTS  FROM  NEW  ENGLAND 
RESIDENTS  (11/08/2012  -  11/14/2012) 

2012-842S 

t_VJ  1  £—  vJT^CiJ 

1 1/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  \_/  1— /  1  1  1/  V- /  III    /  1— /  1  L>  1  / 

MARIA  GRAZIA  VIMERCATI 

\v\r\\  1 i 1  \  \_i  i  \i  \£—  i i  \  v  iivii  I  lun  i  I 

APTALIS  PHARMA  SRL  ITALY  -  OLJALITY  ASSURANCE 

nl      1  1  \  1  IO  1    1  In  1  II  v  1 1  \  \J  1  1 1  ,    II  I  \  1      1         v_><  kw/ 1  \  1  1  1    1    nuvJU  1  I/t  1  N  Vw/ 1  

12/24/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V_/  L-/  |  |  1/  V_/  III    /  [_/  |  ]  1 1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

APTALIS  PHARMA  SRL 

PROFILE  (QAP) 

2012-8426 

1 1/26/2012 
12/24/2012 

CVM/OCD/ 

V_/  V  1 VI/  v_/  V_/  La '/ 

FDA/OC/OES/DFOI/ 

LYNNE  TERRY 
OREGONIAN 

JERKY  PET  TREATS  FROM  CHINA  -  INVESTIGATION  RECS 

<J  1  1  11  \  1     1     l__  1       III  L  1  \  1  \J    1     1   1  \—s  1  V  1    W  1   1  1  1  M 1  V        1  1  >l  V  1— —  \—i  1  1     1  f  \  1  1  Vw/  1  >l    11 1  Vw/  Vw/  y 

LAB  TESTS,  NAMES  OF  MFRS,  ETC  2007  TO  PRESENT 

2012-8427 

11/26/2012 
12/24/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

MURIEL  ASHIE 
MEDTRONIC  INC 

OSTEOTECH  INC,  SHREWSBURY,  NJ  -  EIR  10/6/10-12/9/10 

201  2-8428 

1 1/26/2012 
12/24/2012 

rUA/OO/Utb/UFOI/ 

Brian  Lester 

MANNING  &  NAPIER  ADVISORS 
INC 

NOVAH  I  lb,  bANUUZ  -  48o  (06/1 1  1  O  rHEbEN  1 ) 

2012-8429 

11/27/2012 

ORA/ 

Michael  McBride 

INDIVIDUAL  RECS 

12/26/2012 

ORA/ 

FDA/OGROP/ORA/NE-FO/NWE- 

Michael  McBride 

Page  129  of  895 


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Subject 

Due  Date 

DO/NWE-CB/ 

2012-8430 

11/27/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 

Nicole  M.  Oliynyk 

ASH  STEVENS,  RIVERVIEW,  Ml  -  EIR  (01/01/2012  - 

12/26/2012 

UU/Ut  I  -Ob/ 

ARIAD  Pharmaceuticals  Inc. 

\  eLlo\ld\j  \  (L) 

2012-8431 

11/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Meredith  Reynolds 

K090995 

12/26/2012 

EPIMED  INTERNATIONAL  INC 

2012-8432 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Peter  Breggin,  M.D. 

ACZONE  -  AERS  (01/01/2004  -  1 1/26/2012) 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Peter  R.  Breggin,  M.D. 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8433 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Sarah  Sorscher 

COMPOUNDING  PHARMACIES  -  483S  (04/01/2002  TO 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PUBLIC  CITIZEN 

PRESENT) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L-/ 1  V        1 V  1  1      1  /   -        1  1  1/  V  /  III    /  1  '  1  1_/  1  / 

OKA/ 

ORA/ 

FDA/OGROP/ORA/CE-FO/CHI- 

DO/CHI-CB/ 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 

DO/PHI-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

FDA/OGROP/ORA/SE-FO/FLA- 

DO/FLA-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 

DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 

DO/DAL-CB/ 

FDA/OGROP/ORA/SW-FO/DEN- 

DO/DEN-CB/ 

2012-8434 

11/27/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

Ashlea  Surles 

BAXTER  HEALTHCARE,  MARION,  NC  -  CORR,  483, 

Page  130  of  895 


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Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

12/26/2012 

DO/ATL-CB/ 

WLOS-TV 

WARNING  LETTER,  ETC  (01/01/2012-  11/26/2012) 

2012-8435 

11/27/2012 
12/26/2012 

ORA/ 
ORA/ 

Andrew  Kahn 
UNITE  HERE 

ST  JUDE  MEDICAL,  ARECIBO,  PR  -  UNREDACTED  483 
(09/17/2012  -  11/25/2012) 

2012-8436 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

in^pnh  harton 

JUOCUI  1    UUI  Wj\  1 

CORTICOTROPIN/ACTH  -  ANNUAL  FILINGS 

\S^S  1    I  J    1  V  '  \  '    1    1    I  \w/  1      1  1  \/  1   \W   1    1    1         1  V 1  11  1  N  \S  I  \  1        1     1  l_  1  1  *l  \—A  \—> 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

barton,  joseph 

2012-8437 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

Mark  Thomas 

1  v  1  d  1  l\     III  \J  1  1  1  CIO 

TENOFIR  1%  GEL  -  PROTOCOL 

1  1  1  N  Vw/  1     III     1    /  O    V-^  1  1—        1     1  I  \S  1  Vw/  > — /  \S  1— 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Noseweek  Magazine 

2012-8438 

11/27/2012 
12/26/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

IS  \  / 1  1  il  V  VU    \w/  1  ^/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

RICHARD  N  SHAPIRO 

RICHARD  N  SHAPIRO  LAW  OFCS 

HOWMEDICA  OSTEONICS  CORP  -  ABG  II  MODULAR  HIP 
REPL ACEMENT  K092406 

1  11  1    1  1  \\S  1  Ivll  1  M  1     I  \u  JLTUU 

2012-8439 

11/27/2012 
12/26/2012 

FDA/OC/OES/DFOI/ 

CROSBY  T50417,  COURTNEY 

ENERGY  DRINKS  -  WARNINGS 

2012-8440 

11/27/2012 
12/26/2012 

FDA/OMPT/CTP/OD/ 

AUSTIN  G  STEEVES  IV 

AUSTIN/TRAVIS  COUNTY 
HEALTH  AND  HUMAN  SERVICES 

GENERAL  SNUS,  AUSTIN,  TX  -  INVESTIGATION  RECS 

2012-8441 

1 1/27/2012 
12/26/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

l  A  f  A  \  /  K  1  1 —    OA  l"~\  /~M  A 

WAYNE  SADOWSKI 

NOVARTIS  PHARMACEUTICALS 
CORP 

h  i  e~\  \  /  a  n~ri  o  ni  i  a  r~>  k  n  a  /~>  i —  i  iTir>  a  i  o  /"■>  f~\  nn  i —  «  ox  i  i  a  k  i  s~\  \  it—  i— >    k  i  ■ 

NOVARTIS  PHARMACEUTICALS  CORP,  EAST  HANOVER,  NJ 
-  EIR,  483,  CORR  8/13-23/12 

2012-8442 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  L*/  1  J  /  1  / 

DAVID  C  WEBER 

IS  l  \  V  1  \S    W    V  V  1— —  I  I  1—  1  I 

MUTUAL  PHARM  -  PREDNISONE  ANNUAL  RPT  1955  TO 

i  v  i  *s  i  \s  i  v  i      i    ii  i  \  i  1 1  v  i      i    ii  i— _  is  i  n  i  Vw/  Vw/ 1  *j  i_  I  \  i  n  i  n  ur\L  ill    i     i             i  Vw / 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BEHREND  &  ERNSBERGER  PC 

PRESENT 

2012-8443 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      11  \J  IS  1  1  1/  W  III    /  L*/  1  1  /  1  / 

DAVID  C  WEBER 

IS  I  \  V  1  \S    \S    V  V  1— —  IS  l_  1  I 

UPJOHN  PHARMS/PHARMACIA  -  DELTASONE  ANNUAL 

kw7  1    VJ  Vw/  1   111    1     II  l  \  1  1 1  V 1  \JI  1     1   1 1  \  1  1 1  V  1 1  \  \—/  1 1  V        L*S  1  l_  1  1  \  \S  \S  1  V  1        /  V 1  >l  1  M  *S  /  \  1  

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BEHREND  &  ERNSBERGER  PC 

RPTS  1955  TO  PRESENT 

2012-8444 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  J  /  1  / 

DAVID  C  WEBER 

IS  I  \  V  1  \S    \S    V  V  1— —  I  I  1—  1  I 

ROXANE  LABS  -  PREDNISONE  ANNUAL  RPT  1955  TO 

1     l  \S  /  \  1     \  1   >l  l_      1  1    \  IS)  \S              |        |     1  1         IS  |    *J   |  \S  \S  1    *J  1            /    V  |   >|  |   >|  lS  I     \  Itm.      1     I  1           1           1    \J\J\J  1 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BEHREND  &  ERNSBERGER  PC 

PRESENT 

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12/26/2012 

FDA/OGROP/ORA/PA-FO/LOb- 
DO/LOS-CB/ 

n  A  MM      hJI  I —  I —  DM  A  K  1  r"\/~\ 

RANIL  M  FERNANDO 

BIOSCREEN  TESTING  SERVICES 
INC 

A  A  1      n  /"\  /~\  1  1  A  1    1  T\/  1    ADO    INI          Dl  mOAMI/           A  I —  |  [— >  O      ^  OOO 

MICRO  QUALITY  LABS  INC,  BURBANK,  CA  -  EIRS,  483b, 
WARNING  LTRS  LAST  5  YRS 

V  V  1  V 1  1 1  VI  1 1  v|          L  1  1  I \J    1  /  \  \—>  1     v/     1   1  I V/ 

2012-8446 

1 1/27/2012 

ORA/ 

DAVID  BLOCH 

1  J 1  \  V  1  1 — /    1  J  Lww  1  1 

ST  JUDE  MEDICAL  SYLMAR  CA  -  483  CO  RESP  10/17/12 

Vw*  1     \J  V/  1  /  1        1  v  1 1  L/  1  V_/ /  \  1  j    Vw/  1   ^  1  V  1  /  V 1  I .    V_/ 1  \          t  *_/  v/  ?    V/  Vw/    1  1 1  V/  1        1  V//   1  /  /    1  £— 

12/26/2012 

ORA/ 

MEDTRONIC 

2012-8447 

11/27/2012 
01/07/2013 

FDA/OO/OFBA/OAGS/ 

JEFF  STACHEWICZ 
FOIA  GROUP  INC 

HHSF223200850014I  -  TASK  ORDER  HHS0001 ,  AWARD 
TYPE,  2011  SPENDING,  ETC 

2012-8448 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  IS  1  L/  1  / 

Kpnnpth  Wnlinpr  MD 

1  \tj  1  II  1  Vw*  1 1  |    v  V  \J  1 1 1  1  \j  1  -    1  v  1 1 — / 

HCG  -  AERS  (01/01/1973  -  12/01/2012) 

1   1  Vw/  V_H        /  \  l_  1  l  VwJ    \  v  1  /  V  1  /    1  \J  1  \J          1  £-/  V/  1  /  l_  V/  1  L_  J 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Kenneth  Woliner,  MD 

2012-8449 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

KEITH  STONEBACK 

SEMPRUS  (TELEFLEX)  -  APRVL  OF  NEW  MATERIAL  FOR 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/        III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1—/  1  ]  /  1  / 

FDA/OMPT/CDRH/OCER/DFOI/ 

AGILE  SCIENCES 

CATHETERS 

2012-8450 

1 1/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  11   1/  V-/  \_J  l__  1  1/  1 — /  1    Vw/  1/ 

LISA  ANDERSON 

1  1           \  1   VI  N  l_/  l_  1    I  Vw /  1  VI 

BIRTCHER  MEDICAL  SYSTEMS  INC  -  HYFRECATOR 

i  >  1 1  i  i  \w/ 1  1 1  ii  i  v  1 1— _  i  / 1  v/  v  \  i_  Vw/  i  Vw/  i  i  i  v  i  v/  1 1  >i  v/      i  i  i  i   ii  i_  v/  y  \  i  Vw/ 1  i 

12/26/2012 

CONMED  CORP 

K800617 

2012-8451 

1 1/27/2012 
12/26/2012 

FDA/OC/OES/DFOI/ 

1  1— '  l\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

1  piurpn  Farrunnia 

i —  ciu  iv^ii  i  o.i  i  uy  y 1  w 

Hyman,  Phelps  and  McNamara 

ROCKSTAR  ENERGY  DRINKS  -  CAERS  (01/01/04-10/23/12) 

1  l  Vw/  V/  I  \\J  I  /  V 1  1    1  1  V|  I  |   IV-/   1      L/  1  Hill  V  V/        V  '  /  \  1  1  I V/    1  \J  1  /  V/  1  /  V/ "      IV//  £l_  w  /    1  L—  J 

2012-8452 

1 1/27/2012 
12/26/2012 

FDA/OGROP/ORA/SW-FO/DEN- 

1  1 — '  /  V/  Vw/        1   1 W  1    /  Vw/  1   It  \/  \J  V  V     1    \-S  1  1 — ^  1  1  N 

DO/DEN-CB/ 

.lanip  fiwinn 

\JCkl  1 1  \j    \—A  V V  1 1  II  1 

WATSON  LABORATORIES  INC 

WATSON  PHARMACEUTICALS/LABORATORIES  -  MTG 

V  V  1  V  1  V/  Vw /  1  VI    1     1   1/  VI  1 1  v  1 1  V  V/  1— —  V/  1   1  W  /  V  i—  V//  1  /  VLJV/  1  l/V  1  V_/  1  I  1       V/        1 V  1  1  V_/ 

MINUTES 

2012-8453 

11/27/2012 
12/26/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LAUREN  FARRUGGIA 

Hyman,  Phelps  &  McNamara,  P.C. 

COFFEE  BEVERAGES  -  CAERS  1/1/04  TO  10/23/12 

2012-8454 

1 1/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/  Vh*/  III    /  I — '  1  1  /  1  / 

TONYA  SAUSSER 

i  Vw/ 1  n  i  /  \  o  /  \  v/  Vw/  Vw*  i  i  i 

SANDOZ  GMBH  KUNDL  -  483  10/3-12/12 

Vw*  /  VI  *J  L/  Vw/  L       V_/  1  V 1  E  >  II.    IX  Vw/  1  *J  L/  1              i  w  w     1  \J  I  \J     \  C—l    1  L_ 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

TARSA  THERAPEUTICS  INC 

2012-8455 

1 1/27/2012 
12/26/2012 

1  L—t  L —  V//  L —  \J    1  L — 

FDA/OF/CFSAN/OCD/EOS/ 

ELBEK,  GAIL 

SOY  INFANT  FORMULA  &  FOOD  -  CAERS 

Vw/  Vw/  I      I  I  i|  I    /  VI  HI     1    V/  1  1 1  v  1  V/  1  1  \  VwA    1    V/  Vw/  1 — /        Vw/  /  V  l_  1  1  v/ 

2012-8456 

11/27/2012 
12/26/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

NEELMEGH,  RAMESH 

MEDICVISION  -  SAFECT  PICTURE  ARCHIVING  AND 
COMMUNICATIONS  SYS 

2012-8457 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ZOSTAVAX  -  VAERS 

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FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

SHAPIRO,  ELAINE  L 

2012-8458 

11/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

SILVER  NITRATE  -  AERS 

12/26/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  [_/  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

Doe  J 

2012-8459 

11/27/2012 
12/26/2012 

FDA/OF/CFSAN/OCD/EOS/ 

HELLEN  AOKETCH  PHD 

UNITED  STATES 
PHARMACOPEIA 

AGMATINE  SULPHATE  -  CAERS  1/05  TO  5/12 

2012-8460 

11/27/2012 
12/26/2012 

FDA/OF/CFSAN/OCD/EOS/ 

HELLEN  AOKETCH  PHD 

UNITED  STATES 
PHARMACOPEIA 

N-ACETYL-D-GLUCOSAMINE  -  CAERS  1/05  TO  5/12 

2012-8461 

11/27/2012 
12/26/2012 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

2012-7908 

2012-8462 

11/27/2012 

FDA/OC/OES/DFOI/ 

BRIAN  LESTER 

SANDOZ,  NOVARTIS  -  483S,  WARNING  LTRS  6/1 1  TO 

12/26/2012 

MANNING  &  NAPIER  ADVISORS 
INC 

PRESENT 

2012-8463 

11/28/2012 
12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

K073556 

2012-8464 

1 1/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    I—/ 1  V/  Vw/ 1 V  1 1      1  /  \w/  L-f  1  1  1/  W  III    /  [_/  1  L-/  1  / 

Rarhpl  .Inhn^nn 

1  IQl^l   CI  UUI  II  IOUI  1 

ANDA  090008  -  TENTATIVE  APPROVAL  LETTER 

1  \ \  n  i— / 1  \  \j i  i  w  i  i  \  i  i  v  i     ni   i   i  i Vw/  v  i  \ i     i  i     i  ii  ii 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-8465 

11/28/2012 
12/27/2012 

FDA/OC/OES/DFOI/ 

Amy  Kincanon 

LexisNexis  CourtLink  Document 
Retrieval 

2012-7404 

<i01  ^-8466 

4  4  mo  /OA  ^  f~i 

12/27/2012 

rUA/UG/Otb/DI-UI/ 

Amy  Kincanon 

LexisNexis  CourtLink  Document 
Retrieval 

OAH  O  "7AH  A 

^01<i-7914 

2012-8467 

11/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

AMITIZA  -  AERS  (1 1/02/2009  -  1 1/27/2012) 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

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FDA/OMPT/CDER/ORP/DIDP/ 

2012-8468 

11/28/2012 

ORA/ 

Helena  Mateus-Martins 

ENTRY  97E-0005593-0  -  ANALYTICAL  REPORT 

^  O  /0"7  /OA  ^  o 

1  dl d  1 1 d0\  d 

UKA/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

J&K  hresn  bast  a  div  ot  i £a 
Logistics 

2012-8469 

1 1/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  1  \i  V_/ 1 V  1  1      1  /  W  l_/  1  1  1/  W  III    /  [_/  1  1  '  1  / 

I  vicii  II ov_|  a 

NDA  1 1661!  (MESTINON  ER  TABLETS^  -  SBA 

1  N  L/ 1  \     1    1  UUJ    I  1  VI 1  Vj  1  1 1  4  V  >  INI  II     |  1  \  1  )  [  1       |  v  )  J  uun 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  1  \i  Vw/ 1 V  1  1      1  /  V/  1— /  1  1  1/  V_/  III    /  l_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

LUNDBECK  INC 

2012-8470 

11/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Lauren  Farruggia 

ROCKSTAR  ENERGY  ADVERSE  EVENTS  -  83060,  86399, 

12/27/2012 

Hyman,  Phelps  and  McNamara 

87069,  ETC 

2012-8471 

11/28/2012 
12/27/2012 

ORA/ 
ORA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Marie  Sullivan  and  Suzanne 
Robinson 

Pain  Consultants  of  Wpst  Florida 

1    dill  Wl  IOU 1  LCll  1  lO  Ul    Vfwl  1    IUI  lUQ; 

PA 

SAMPLE  RESULTS 

2012-8472 

11/28/2012 
12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Laura  Boll 
Medovations  Inc. 

K090183 

2012-8473 

1 1/28/2012 
12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/ 1  v  1 1      1  /  V/  l_/  1  1  1/  W  III    /  (_/  1 1_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Paul  .1  Davis 

1     QUI   U.    L'QV  IO 

Paul  J.  Davis 

PHENYTOIN  -  DETAILED  REPORTS  OF  LEFT  BUNDLE 

1     1   1  1  1  *J    1     1  Vw/  1  1  N         1  /  1       1  /  \  1  1  l_  L/    1  1 1  1     Vw/  III  V/   \  '  1       1  1  1      1     I—/  V_/  1  *J  L/  1  l_ 

BRANCH  BLOCK  (01/01/2001  -  12/31/2011) 

2012-8474 

1 1/28/2012 

FDA/OO/OES/DFOI/ 

1    L//V/  V_/\_//  Vw/ 1 — \J/  1— /  1   v_x  1/ 

LuU  1  CI  LJUII 

K061937 

I  \UU  1  CO  1 

12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

MEDOVATIONS  INC 

2012-8475 

11/28/2012 
12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Doe  J 

BIOMET  MICROFIXATION  -  AER 

2012-8476 

1 1/28/2012 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    L/  / V/  Vw/ 1 V  1  1      1  /  V/  L_>  1  1  1/  V/  III    /  1— '  1  l  '  1  / 

FORTICAL  SPR  -  AER 

1    V_/  1  1  1  1  V/ 1  \ 1      \J\    1  I       / V 1  1  I 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  W  l_/  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

GONZALES,  GRACE 

2012-8477 

1 1/28/2012 
12/27/2012 

FDA/OC/OES/DFOI/ 

JACKIE  HERNDON 
ZAREMBA  BROWNELL  ET  AL 

CIPROFLOXACIN  -  RECS  CERT 

2012-8478 

11/28/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

CMPLNT 

12/27/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

Doe  J 

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DO/LOS-CB/ 

2012-8479 

11/28/2012 
12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

KEVIN  STRANGE 

WELLS  FARGO  SECURITIES 

HEARTWARE  VENTRICULAR  ASSIST  SYS  -  SAFETY  & 

trrtU  1  1 V  tINJtoo  rIVIA  r\  UUU4/ 

2012-8480 

11/28/2012 
12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

R.  SCOTT  JENNINGS 
TRANSPHOTON  CORP 

APEX  DETECTOR  ELECTRONICS  &  ACQUISITION 
INTERFACE  MODEL  XL4  K033001 

2012-8481 

11/28/2012 
12/27/2012 

FDA/OMPT/CBER/OCOD/DDOIW 
ALFB/ 

Doe  J 

MERCK  -  HIB  VACCINE  RECALL 

2012-8482 

11/28/2012 

FDA/OO/ 

MARK  L.  FLATTEN 

EMPLOYEE  DATA  -  OFFICIAL  TIME  USE 

12/27/2012 

FDA/OO/OHR/ 

WASHINGTON  EXAMINER 

2012-8483 

11/29/2012 
12/28/2012 

FDA/OC/OES/DFOI/ 

Megan  Pickel 
BEVERIDGE  &  DIAMOND 

CFSAN  FOIA  REQUESTS  (10/26/2012  -  11/28/2012) 

2012-8484 

11/29/2012 
12/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
LP. 

COCA  COLA  -  AERS 

2012-8485 

11/29/2012 
12/28/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Lisa  Anderson 
ConMed  Corporation 

K33497 

2012-8486 

11/29/2012 
12/28/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

E  Neely 

St.  Jude  Medical 

BOSTON  SCIENTIFIC  -  RESPONSE  TO  WARNING  LETTER 
DATED  01/25/06 

2012-8487 

11/29/2012 
12/28/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

E  neely 

St.  Jude  Medical 

MEDTRONIC  CDRM  -  WARNING  LETTER  RECS  (1 1/09/2009  - 
11/01/2012) 

2012-8488 

11/29/2012 
12/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
LP. 

PEPSI  -  AERS 

2012-8489 

11/29/2012 
12/28/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

John  P.  Waters 
Whip  Mix  Corporation 

K925375 

2012-8490 

11/29/2012 
12/28/2012 

FDA/OO/OFBA/OAGS/ 

Gina  T  Weismann 

TD  Equipment  Finance,  Inc. 

CONTRACTING  OFFICER  WARRANT  OF  AUTHORITY 

2012-8491 

11/29/2012 
12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Rita  Choi 

George  Mason  Law  &  Economic 
Center 

APPROVABLE  LETTERS,  NOT  APPROVABLE  LETTERS, 
COMPLETE  RESPONSE  LETTERS  FOR  LISTED  DRUGS 
(06/26/1997-  11/28/2012) 

2012-8492 

11/29/2012 
12/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
LP. 

PEPSI  ENERGY  DRINKS  -  AERS 

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/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8493 

11/29/2012 
12/28/2012 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

L/          1 V  1  1  1  M    \—s  1  // 

E  Neely 

St.  Jude  Medical 

GUIDANT  CORPORATION,  ST  PAUL,  MN  -  RESPONSE  TO 
483  ISSUED  2/09/06 

2012-8494 

11/29/2012 
12/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Shailini  Rao 

Eton  Park  Capital  Management, 
LP. 

PEPSI  -  AERS 

2012-8495 

t—\J  1  t—  v/  i  \J \J 

1 1/29/2012 

1    tit—  \J/  t—\J\C— 

12/28/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    L/  /  V/  Vw/  1    /  Vw/  1         /  V 1  VI/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

Omari  RamirP7 

\S  1  1  1  CI  1  1    1  I  C4  1  1  III  w  i_ 

Water  Island  Capital,  LLC 

TEAVANA  HOLDINGS  -  SAMPLE  ANALYSIS 

1  l—  1  \  V  1  \  1  V/  \   1   1  Vw/  l—  L/  1  1  Ml       v_/        V/  / \  1  VII     1—  1        /  \  1  VI  1  \  1       1  Vw/  1 

2012-8496 

11/29/2012 
12/28/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Kevin  A  Henry 
UNIVERSITY  OF  UTAH 

MAMMOGRAPHY  FACILITIES  -  NUMBERS  OF  MACHINES, 
CAPACITY,  DIFFUSION,  ETC  (01/01/2003  -  12/31/2011) 

2012-8497 

1 1/29/2012 

1     tit—  \JI  L—\J\t— 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — r  1  l  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

KATE  C  BEARDSLEY 

1  \I  \  1  1— —    V/    1  >  1—  1  V 1  1 1  /  V/  L_  1   1 

ZUCKERMAN  SPAEDER  LLP 

SUN  PHARMACEUTICALL  INDUSTRIES  -  SUMATRIPTAN 

Vw/  KJ  I  H    I     II  /  \  1  1 1  VI/  \  W  1  kw/  1  1  V  '  I  \  1  1       II  i|  1  /  V^/  ^/  1  1  1 1  1  VwJ        V/  1 — J  1 V  1  /  V  1  1  1 1  1      1  1  \  1  M 

AUTO-INJECTOR  ANDA  09-0358  SBA,  APRVL  PKG 

2012-8498 

1 1/29/2012 

1     tit—  \J/  L—\J\S— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1 V  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

KATE  C  BEARDSLEY 

1  \I  \  1  1— —    V/    1  >  1—  1  V  1    l  1  '  V./  1  1   1 

INTELLIJECT  -  AUVI-Q  fEPINEPHRINE  INJ  USP^  NDA  20- 

1  1  *l  1  1— —  1  1  lu  l_  Vw/  1         I  \  Vw/  V  1    v_/    1  l_  1     II  il  l_  1     1   1 1  1 1 1  v|  |        j  |  v|  \j    \_j  \S  1     JIM  1  >  1  \  L—  \J 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ZUCKERMAN  SPAEDER  LLP 

1739  SBA,  APRVL  PKG 

2012-8499 

11/29/2012 
12/28/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

HAMILTON,  LEROY  LESLIE 

DESIGNATION  FORM  FDA  3429  -  ALL  VERSIONS  THAT 
EXISTED  PRIOR  TO  THE  ASSIGNMENT  OF  THE  FORM 

2012-8500 

1 1/29/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L*s  1  1  1/  V_/  III    /  t — '  1  l_/  1  / 

JOHN  B  BRAUNSTEIN 

\J  V_/  1   1  1  VI    E  >    1  '  1  1 1  \  \-)  1  VI  \J  1  l_  1  1  N 

ASACOL  (MESALAMINE)  -  AERS 

/  V  Vw/ /  V  Vw/  Vw/  1       1  1  v  1  1  v_/ 1  \  \  /  VI V  1  1 1  <l  1      /        1  \  \  1  I  v_^ 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

VOUTE  LOHRFINK  MAGRO  LLP 
ET  AL 

2012-8501 

11/29/2012 
12/28/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

JENNIFER  GRAMLILNG 
SAMSTER  KONKEL  ET  AL 

WHEATON  FRANCISCAN  HEALTHCARE-FRANKLIN  - 
TETANUS  VACCINE  RECS  (CERTIFIED) 

2012-8502 

11/29/2012 
12/28/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

ORA/ 

ORA/ 

PETER  D  LOFTUS 
Dow  Jones  &  Company 

OHM  LABORATORIES,  NEW  BRUNSWICK,  NJ  -  483'S; 
RANBAXY  LABS  -  ATORVASTIN  CALICUM  ANDA  07-6477 
CO  RESP  1 1/30/1 1  TO  PRESENT 

2012-8503 

1 1/29/2012 
12/28/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  1  }  1—  1  1/  Vw/  \w/  V_/  L/  /  1 — /  (_/  \w /  1 V 1/ 

ALFB/ 

NEIL  SHEEHY 

1  M  1— —  1  I       v/  1   1 1— —  l_  1   1  I 

NEIL  SHEEHY 

ETHICON  (JOHNSON  &  JOHNSON  CO)  -  FIBRIN  PAD  PROD 

1       1  1   1  1  Vw/  Vw/  |  VI    1  U  Vw /  1   1  1  VI  \J  Vw/  |  V|    VJV  KJ  V*/  1   MM  V_/  Vw/  1  N    V/  W  /        1     1  1— '  1  1 1  1  VI    1     /  V 1 — /    1     11 W  lw/ 

LICENSE  APPL  RESP  LTR,  LBLG,  CO  RESP  10/5/12 

2012-8504 

11/29/2012 
12/28/2012 

FDA/OC/OES/ 

HENSON  SR.,  J.  DONALD 

LAURIE  LENKEL  -  NAME  &  POSITION  OF  THE  INDIVIDUAL 
GIVING  THE  ASSIGNMENT,  CORR 

2012-8505 

11/29/2012 

FDA/OF/CFSAN/OCD/EOS/ 

VOLUNTARY  NATIONAL  RETAIL  FOOD  REGULATORY 

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Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

12/28/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

CORBETT,  SUZANNE 

PROGRAM  STANDARDS,  ASHFIELD,  MA  -  RECIPIENTS  OF 

DO/NYK-DCB/ 

FUNDING,  COLLECTION  FORM.  LIST  OF  VENDORS,  ETC 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

2012-8506 

11/29/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Siobhan  Briley 

AMERICAN  DIAGNOSTICA,  STAMFORD,  CT  -  51  OK 

12/28/2012 

DO/NWE-CB/ 

Sullivan  &  Worcester  LLP 

SUBMISSIONS'  483  WARNING  LETTERS  ETC 

\JUUIVMwUIV/llO.    T^UU,    VVrVI   1 1  N  1 1  M  V_>4    1  1       1    1  1  1   1  >— ' .    1       1  \J 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-8507 

L—\J  1  £_    U  JU  / 

1 1/29/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

1  1— /  / V/  Vw/       1                /  V_/ 1  l/x/V_f[        |    \_//  1     1  II 

Tnnv  Tavlnr 
i  \ji  \y  i  ci y  i kj i 

pncMicR  RESEARCH  PHILADELPHIA  PA  -  483  (01  /01  /2008 

1    1  11  Ivlll  1  1  1  11  v  }  1  I  V 1  1  \_/  1  1,    1    1  1  1 1  1  \  L/  1  1  1    1  1  ir\,    1    1  \       ^\J\J   IV/  1  /  \J  \  1  C-\J\J\J 

12/28/2012 

DO/PHI-CB/ 

AESCULAP 

-  11/28/2012) 

2012-8508 

1 1/29/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— /  / V/  Vw/ 1 V  1 1      1  /  \_/  L/  1  11   \l\J\Jl  1  1/  l_/ 1  V_/|/ 

1  ii i  . limin 

l_l  LA   \J  1 1  1  1 1 1  1 

K110186  K12213R 

l\l     1  W   1  UU,     1  \  1  L_L-  1 

12/28/2012 

Hexalotus  Technology  Pte  Ltd 

nvM/or.n/ 

w  v  i  viz  v_y  v_/ l// 

f^arpv  f^illam/Rpi  itPTQ 
ocucy  vjiiiaiii/ncuLCio 

RNFflfini?4  nA9-RR41fi-4    RMFflfimPR  MDN  R770ft 

DNr  UUU  1  tt,  L//\0  UOH  1  U           Dl  NT  UUU  1  L.  J.  IVI\_/I  M  O  /  1  \J\J 

12/31/2012 

1  t—l  \J  1  /  t—\J  1  £_ 

FDA/OF/CFSAN/OCD/EOS/ 

REUTERS 

2012-8510 

11/30/2012 

FDA/OMPT/CTP/OD/ 

elliot  favus 

MENTHOL  IN  CIGARETTES  -  RECS  (01/01/2011  -  12/31/2011) 

03/20/2013 

\J\Jl  C-\JI  C-\J  1  O 

OC/COS/OES/ 

Vw/ v_/  O/  V_/ 1 — vJ/ 

FAVUS  INSTITUTIONAL 

1    i  V  V  W  vJ    1 1  >l  V  '  1  1  1  \J  1  1  Vw/  1  N 1  \  \  

OC/COS/OES/ 

v_/ v_//  \_/V_/0/  v/ 1 — vj/ 

RESEARCH  LLC 

2012-851 1 

1 1/30/2012 

FDA/OMPT/CTP/OD/ 

Elliot  Favu^ 

1 —  1  II  W  L    1     UV  U\J 

MENTHOL  IN  CIGARETTES  -  RECS  (01/01/2012  -  1 1/29/2012) 

\J\JI  C.\Ji  C.\J  i  o 

on/no^/OF^/ 

wo/  owo/  v-*to/ 

FAVII^  IKI9TITI ITIDNAI 

1  t  \  V  UO  UNO  1  1  1  <J  1  IV_/INrAI_ 

0C/C0S/0ES/ 

RESEARCH  LLC 

2012-8512 

1 1/30/2012 

1    1  /  X-/  V//  LU  1  L 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  1 — /  1  1—/  1  / 

nharmarnkinptir  data  of  Pitrp^in 

k/l  IUI  1  1  IClVsWlM  1  1 V?  LI  Vj  \J  C4.  LC4.  V/  1    1     1  L 1  V/OO 1 1  1 

PITRESSIN  -  CLEARANCE  DATA 

1       1    1    1    1  1— —  V_/  V_/  1  1  ^1           Vw/  1  1  /    V  1    1 1    V  1  M  Vw/  1— —     l—r  /    V   1   1  \ 

12/31/2012 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1  1— /  / V/  Vw/ 1 V  1 1      1  /  V_/  l_/  1  1  1/  V/  III    /  1— '  1 1  '  1  / 

(vasopressin  injection) 

FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  HOUSTON 

COLLEGE  OF  OPTOMETRY 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8513 

1 1/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  1 — '  1  ]  /  1  / 

.InNpl  N  Alprria 

NEW  ENGLAND  COMPOUNDING  CENTER  -  MEDWATCH 

1  *J  1      V  V    1  1     V>1  1  /  V 1  N  1 — /    Vw/  Vw/  1  V 1  1     Vw/  \_>  1  >l  1 — '  1  1  i|          Vw/  1— —  1  il  1  l_  II        1  v  1  1— —  1 — '  V  V  1  \  1  Vw /  1  1 

IP/^l/Pfil? 

1  £_/  O  1  /  C\J  1  C 

FDA/nMPT/nnFR/DRP/nmp/ 

r  vj r\i  v_/ivi  n  i  /  v_/ i_/  r__  rv  v_/ i  1 1  / 1_/ 1 1_/ 1  / 

1 V  1  O  1  N  Dv/.  V_/ V_>  1 V 1 

RPTS  (05/21/2012-  11/29/2012) 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    !  '  / V/  Vw/ 1  v  1 1     1  /  V/  l_/  1  1  1/  V/  III    /  1— '  1  1— '  1  / 

i- r-\  a  if~\\.  a n~r //*~> r~\ i —  n  //-\ nn/r\inn/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8514 

1 1/30/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 

Joanne  Matusko 

MIRENA  -  APPLICATIONS,  MANUALS,  CORR,  ETC 

12/31/2012 

DO/NWJ-CB/ 

M-.ii  «...    1  1 

NastLaw,  LLC 

FDA/OMPT/CDRH/OCER/DFOI/ 

OC/COS/OES/ 

OC/COS/OES/ 

0C/C0S/0L/ 

0M/0MP/D0DM/ 

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V_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUI  u/  ricLIUtJoLci 

OUUJtfOl 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1 1      11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8^1 5 

t—  \J  1  C   \J\J  1  \J 

1 1  no/20 12 

I  I  /  \j\jf  C-\J  I  c 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  \J  \—t  1  1  1/  W  III    /  !_/  1 1  '  1  / 

DflviH  Friprlmpn 

L/  d  V  IVJ    1    1  1          1  1  1  CI  1  1 

XIAFL FX  -  STATISTICAL  ANALYSIS  PLAN  FOR  PHASE 

/\  1 l\  1    1  1  /\       \J  1  i  \  1  1  vJ  1  IUmI      r\l  MnL  1  vJ  1  vJ   1    1  i  V  1  M    1    v  '  1  1  1    1  1 1  \  v  J  1  

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  V_/  III    /  L/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Morgan  Stanley 

THREE 

2012-8516 

1 1/30/2012 

1     1  /  \J\Jl  L—\J\l— 

12/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

.lo^h  .lamP9 

UUOI  1   O  CI  1  1  1  o 

BRYAN  CAVE  LLP 

OCEAN  SPRAY  CRAISINS  NISSIN  TOP  RAMEN  SABRA 

Vw/ Vw/ 1_ i  \ i  nj  v/ 1    i  i y  \  i  > — / 1  t /  v i v/ 1 1  nj \_/ ,  i  4i v/ v/ 1 1  n    i  Vw/ 1     i  i /  v i v 1 1_ _ i  *i ,  \—) i  \ \  > i  i /  \ 

HUMMUS,  ETC  -  CAERS 

2012-8517 

11/30/2012 
12/31/2012 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DAVID  SCOTT  BLUE 
ZETETIC  INC 

SEXY  HAIR  STYLING  AND  TREATMENT  PRODS  ENTRY 
#EHP00759408  -  RECS 

TT  1 — 1   II     \J\J  1             i                  1  11 — V*/  V — ' 

2012-8518 

11/30/2012 
12/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALISON  M  AGNEW 

PILLSBURY  WINTHROP  SHAW 
PITTMAN  LLP 

2012-6833 

2012-8519 

11/30/2012 
12/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

GUBEN,  ALISON 

COCA  COLA/DIET  COKE,  PEPSI  COLA/DIET  PEPSI,  JOLT 
COLA  ETC  -  CAERS 

W  Vw/  L_  /  V  y    I       1  V/        Vw/  /  V  l_  1  1 

2012-8520 

1 1/30/2012 
02/01/2013 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/00/OFBA/OAGS/ 

r~\  a  k  1 1 r~  i          i  a  n  r*i  i  i 

DANIEL  G  JARCHO 

MCKENNA  LONG  &  ALDRIDGE 
LLP 

IEH  LABORATORIES  &  CONSULTING  GROUP  -  PATHOGEN 
PREVALENCE/BASELINE  STUDY  IN  FRESH  PRODUCE 
CONTRACTS,  INVOICES,  CORR,  ETC 

2012-8521 

1 1/30/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  V/  III    /  !_/  1  1— /  1  / 

TENECIA  SULLIVAN 

1  1  1  M  1  \J  In  v  '  \_r  1  1  IV  i  \  1  N 

McjuYLENE  BLUE  -  ISRS  3236013-5  3839924-2  3989080- 

I  V  1 1       1  1  1  1  1  1  INI       \—i  \  \->  1           1  v  '  1  \  v  '  \JC-\J\J\J  1  \J    \J  ,   JUvJi/i/l.^   C—  ,  \J  \J\J\J\J\J\J 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  V— III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SALAMANDRA  LLC 

5,  ETC 

2012-8522 

11/30/2012 
12/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

GUBEN,  ALISON 

COFFEE  - CAERS 

2012-8523 

1 1/30/2012 

1     1  /  \J\JI  L-\J  1  £_ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  / V/  Vw/ 1 V  1 1      11  \J  1— /  1  1  1/  V_/  III    /  L/  1  L/  1  / 

.  Iovpp  1  pp 

LSD  -  APPROVALS  WARNING  DISCLOSURE 

i  ul/      i  » i    i    i  iw  v  nLw,   v  v  r\i  inn  nu,  l/iuv/lv/uui  ii  

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MORRISON  &  FOERSTER  LLP 

2012-8524 

1 1/30/2012 

i  if  v/  v/  /  l —  v/  i  l — 

FDA/OMPT/CDER/ORP/DIDP/ 

KATE  PURCELL 

PAR  PHARMS  -  ANDA  91-340,  ANDA  91-341  APRVL  LTRS 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DOCUTRIEVAL  INFORMATION 
SERVICES 

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Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8525 

11/30/2012 
12/31/2012 

ORA/ 
ORA/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

R  IAN  KLUGE 

Hyman  Phelps  and  McNamara  PC 

FRESH  FISH  FILETS  ENTRY  #235-1509680-0  -  SHIPPING  & 
PACKING  RECS 

2012-8526 

11/30/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

MCKENZIE  CATO 

FLORIDA  BIOLOGIX,  ALACHUA,  FL  -  RECS 

12/31/2012 

DO/FLA-CB/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Hyman  Phelps  and  McNamara  PC 

2012-8527 

11/30/2012 
12/31/2012 

FDA/OO/OFBA/OAGS/ 

FOI  Services,  Inc. 

NATIONAL  ENVIRONMENTAL  HEALTH  ASSN  AWARD 
NUMBER  U45FD  004325  -  COOPERATIVE  AGREEMENT 
9/1 6/1 1 ,  8/1 4/1 2,  8/29/1 2,  ETC 

2012-8528 

1 1/30/2012 
12/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L- /  1  11   1/  V_/  Nw/  l_  1  1/  1 — /  1    Vw/  1/ 

FOI  Services,  Inc. 

PROSURG  -  EVA  K001576 

1     1   l  V_/  *S  *S  1  1  Vw/         1       v  1  \    \WJ\J  1  \J  1  \J 

2012-8529 

11/30/2012 
12/31/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

KRISTI  0  SMEDLEY  PHD 

Center  for  Regulatory  Services,  Inc. 

SPARHAWK  LABORATORIES  INC,  LENEXA,  KS  -  EIRS,  483S 
6/1/05  TO  PRESENT 

2012-8530 

11/30/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

KIM  C  CAPONE 

PFIZER  INC,  NEW  YORK,  NY  -  EIR,  483  101/15/12 

12/31/2012 

DO/NYK-DCB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

PORZIO  BROMBERG  &  NEWMAN 
PC 

2012-8531 

1 1/30/2012 
12/31/2012 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

DANIEL  STEIN 

RICHARDS  KIBBE  &  ORBE  LLP 

ABIOMED  INC,  DANVERS,  MA  -  IMPELLA  RECOVER  LP  2.5 
PERCUTANEOUS  CARDIAC  SUPPORT  SYS  CORR  1/1/08  TO 

i    i  i  i  Vw/  \s  i  /  vi  n  i— _  v_/  %s  \s  v/y  vi  v  is  1 1  \  v_/  \s  \s  i    i   v/ 1  i  i    u  i  u  \s  v/  iiii    \  i  i  /          i  \s 

PRESENT 

2012-8532 

12/03/2012 

1  I—/  \J\J/  L—\J\C— 

FDA/OGROP/ORA/PA-FO/LOS- 

1    IS  1  \l  Vw/  Vw^  1  1  Vw/  1    /  Vw/  1  IV  V/  1    / \    1    Vw//  LV/w 

MIJIB  U  QIDWAI 

1  V  1  lu  1  IS    \S  .            1  IS  V  V  I    \  1 

BAXTER  LOS  ANGELES  CA  -  EIR  483  10/12 

IS  1  \/\  1  1  1  l  j    LV/U   1  V 1  M  V_/  l_  1  l_  \S  ,    VJ/t        1  11  I  n    "LJ  w     IV//    1  £— 

01/02/2013 

DO/LOS-CB/ 

GRIFOLS  BIOLOGICALS  INC 

2012-8533 

12/03/2012 

i  C—l  \J \JI  C—\j\l— 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \h/  Lp/  1  11   1/  V_/  V^/  l__  1  1/  \S  1    Vw/  1/ 

ROBBI  PERRY 

1  l  \S  IS  IS  1    1     1  1  11  I  1 

NORTH  AMERICAN  RESCUE  LLC 

BELMONT  INSTRUMENT  CORP  BILLERICA  MA  -  BUDDY 

L/  1  1  1  V 1  Vw/  1  *J  1     II  i|  V/  1  1  1  KJ  1 V  1  1— —  1  il  1     \S  Vw/  111     ,    t  J  1  1  I  l__  1  11  Vw/ 1  \  «    1  v  l/«        L_/  V/  1 — '  IS  1 

PLUS  FLUID  WARMER  -  K062774 

2012-8534 

12/03/2012 

1  t—l  \J\JI  L—\J\S— 

01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    1  /  /  V/  Vw/  1    /  \S  1         1  \  1  >!/  Vw/  Vw/  l_//  l_  Vw/  V-// 

ALVIN  J  LORMAN  LAW  OFC 

FCN  1 177 

1    \S  IN     1    1  /  / 

2012-8535 

12/03/2012 
01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  / v  Vw/  1    /  \w/  1    v//\  1  >!/  Vw/  Vw/  1 — /  /  l__  Vw/  U/ 

ALVIN  J  LORMAN  LAW  OFC 

FCN  1 188 

1    V/  \  M     II  VJ  V/ 

2012-8536 

12/03/2012 
01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ALVIN  J  LORMAN  LAW  OFC 

FCN  1 145 

2012-8537 

12/03/2012 
01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JIM  KUSTERS 
MORIA  INC 

K090626 

Page  139  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8538 

12/03/2012 
01/02/2013 

FDA/OGROP/ORA/CE-FO/CHI- 

i  i— / 1  \i  Vw/      i  i  v_/  1   /  V_/ 1  in/  \J  1       1    V_//  \J  1  II 

DO/CHI-CB/ 

MrKENZIE  CATO 

1  v  1  L»  1  \  I  IN£_II       Vw/ / V  1  Vw/ 

Hyman,  Phelps  and  McNamara 

ORGAN  RECOVERY  SYSTEMS  INC  -  RECS 

Vw/  1  I  \w/ / V 1  M    1  1 1  W  Vw/  VI  III     VwJ  1  VwJ  1  1  1  V 1  Vw/    1 1  N  V_/        1  1 1  Vw/  v  ) 

2012-8539 

L—\J    1  t—  \J^J\J\J 

12/03/2012 
01/14/2013 

FDA/OGROP/ORA/CE-FO/DET- 

1  1 — '  1  \l  \w/        1   I  \-s  1    /  \w/  1  1/  V/  V_/  l_    1    \_s  1  ]—/  1   1 

DO/DET-CB/ 

STEVEN  D  BROCK 

\—J     1     l_    V  1— —  1    *J       I  '   m       \—>  1     I  Vw/  *w/  |  \ 

JOHNSON  LAW  PLC 

INDIVIDUAL  RECS 

1  1   M  lw/  1    V    1  lw/  Vw/  / \  1            |     I  1         Vw/  Vw/ 

2012-8540 

12/03/2012 

1  t—l  \J\JI  S—\J\t— 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/  1  \l  Vw/  1 V  1  1      1  /  Vw*  L/  1  11   1/  Vw/  W  1— —  1  1/  1  /  1    Vw/  1/ 

Jinn  fip 
Ge,  Jing 

HEARTWARE  VENTRICULAR  ASSIST  DEVICE  -  STUDY  DATA 

1   1  1  /  VI  11    V  V  1  V 1  1 1_     V  1  1  i  1  1  11  Vw/  Vw/  1  /  1 1  I   /  VVw/  Vw*  1  w  1     lw/  1       V  1  V-/  l_        V/  1  Vw*  lw/  1     lw/  /  V  1  1  \ 

FOR  100  PATIENTS 

2012-8541 

12/03/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Megan  Mularcyzk 

INDIVIDUAL  RECS 

01/02/2013 

ALFB/ 

Pretzinger,  Liz 

2012-8542 

12/03/2012 

1  t—l  \J\JI  S—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

Rophpi  .Inhn^on 

1  IClVvl  1  Vj  1   Uvl  II  IOV/1  1 

NDA  21951 

1  M  1  '  1  \  L—  1  \J \J  1 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  lw/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-8543 

12/03/2012 

1  t—l  \J\Jl  S—\J\t— 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1      L/  /    V/  Vw/  1  v  1  1        1  /  Vw/  lw/  1    11     1/  Vw/  Vw/  1— —  1    1/  1  /  1      Vw/  1/ 

Carpv  Fnlk 

V/Cll  t/V    1    V/ 1 1\ 

New  Country,  LLC 

K052732 

1  V  V/  v/ t—  1  Vw*  £— 

2012-8544 

12/03/2012 
01/02/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Dominic  DeMuro 
PFIZER,  INC 

PFIZER,  SANFORD,  NC  -  EIR  (1 1/201 1 ) 

2012-8545 

L—\J  1  t—              i  «J 

12/03/2012 

1  t—l  \J\JI  S—\J\t— 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  1    \l   Vw/  |  V  1  1          1    /  Vw/  lw/  1         |     1/   Vw/  III       /    |_/  |  |w/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  /    V/   Vw/  1  V  1  1          1    /  Vw*  lw/  1         1     1/   Vw/  III       /    lw/  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

KAVITA  SRIVASTAVA 

1  V/  \  V  1  1  1  \   KJ 1  1 1  V  1  \  Vw'  1  1  \  V  1  \ 

TARO  PHARMACEUTICALS  USA 
INC 

GLENMARK  GENERICS  -  FLUTICASONE  PROPIONATE  SBA 

Vw/  1  1  1  VJ  1  V  1 1  V 1  1 1  \   Vw/  1  1  *J  1  III  Vw*  \w/        1    1—  Vw/  1  1  *wT\WVy  1  *l  1— —    1     1  I  Vw/  1     1  Vw/  1  N  /  \  1  1        Vw/  1  '  i  \  - 

CHEMISTRY  RVW,  LBLG,  ETC 

2012-8546 

12/03/2012 
01/02/2013 

FDA/OC/OES/DFOI/ 

Silvia  Gambardella 
WTVD-TV/  ABC 

PET  JERKY  TREATS  -  COMPLAINTS  FROM  NORTH 
CAROLINA 

2012-8547 

12/03/2012 

1  t—l  \J \JI  t—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  1    \l   Vw/  |  V  1  1          1    /  Vw/  lw/  1         1     1/   Vw/  III       /    lw/  1  lw/  1  / 

Annplia  Slav/ton 

ni  iuuiiu  vj iciy  I v/ 1  i 

HYCAMTIN  -  APPROVAL  LABELING  MEDICAL  REVIEW  ETC 

1   1   1  Vw/  /  II V  1  1   1  1  VJ        /  \  1     1     1  l  Vw/  V  1  V 1  „    l—i  \  1—/  1  1  1  1  M  Vw/  ,    1 V  1  1— —  lw/  1  Vw/ /  V 1       1   1 1_  V  1  1      V  V  -    l_  1  Vw/ 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  1    \l   Vw/  |  V  1  1          1    /  Vw/  |w/  1         1     1/   Vw/  III       /    L/  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2012-8548 

t_v/  1  £—  Uu"U 

12/03/2012 

1  t—l  \J \Jl  L—\J\C— 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       lw/  /    V/   Vw/  1  V  1  1          1    /  Vw*  lw/  1     11      1/   Vw/  Vw*  1— —  1     1/    lw/  1       Vw/  1/ 

Fmilv  Nunpnt 

l_  1  1  1 1 1  y    1  MUU  \j  1  1  L 

Dickson  Geesman  LLP 

K091057  K092356  K1 00403 

1  V  V/  \Z  1  \J\J  I  1    l\u  *_/  £_  Vw*  V-/  V/  .    1  V  1  \/  V/    l  v/  O 

2012-8549 

12/03/2012 
01/02/2013 

V_>   1  /  \J  t—l  L —  \J    1  \_J 

FDA/OF/CFSAN/OCD/EOS/ 

Anna  Edney 
BLOOMBERG  NEWS 

STARBUCKS  COFFEE,  HOSTESS  TWINKIES  -  CAERS 
(01/01/2004-  10/19/2012) 

2012-8550 

12/03/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Yu-Ju  Chiang 

K033474 

01/02/2013 

FDA/OC/OES/DFOI/ 
FDA/OC/OES/DFOI/ 

Chung  Yuan  Christian  University 

Page  140  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8551 

12/03/2012 
01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Robert  Blinn 
Pura  Vida  Funds 

P950022  S014 

^01/i-o55<i 

1 2/03/^01 2. 
01/02/2013 

rUA/UO/Utb/Dr(JI/ 

\  / 1  r~\  a    i  /~\  i  i  k  i  o  /~\  k  i 

VIDA  JOHNSON 

WONDER  FIBER  MASSAGE 
PRODUCT  INC 

HtAL  1  H  OAKt  1  HtKAI-'tU  1 10  LIQUID  -  ArKVL 

2012-8553 

12/03/2012 

FDA/OC/OES/DFOI/ 

Yu-.lii  Ohiann 

K01 1 144 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Chung  Yuan  Christian  University 

2012-8554 

12/03/2012 
01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

GUBEN,  ALISON 

RED  BULL-  AER  1/04  TO  11/1/12 

2012-8555 

12/04/2012 
01/03/2013 

ORA/ 
ORA/ 

FDA/OGROP/ORA/SW- 
FO/SWID/SWID-CB/ 

BENJAMIN  ENGLAND 

BENJAMIN  L  ENGLAND  & 
ASSOCIATES  LLC 

HAINAN  QINFU  FOODS  CO  LTD  -  ENTRY  #316-7043761-0 
COLLECTION  RPTS,  STORAGE  RECS,  INVESTIGATIONS, 
ETC 

2012-8556 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
UU/NWJ-Cd/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

PAUL  W  TRIPP 
LINCARE  INC 

MEDILINK  HOMECARE  INC,  NJ,  PA  -  EIRS,  483S,  WARNING 
L 1  Kb  1/1 05  I  U  rhitbtN  I 

2012-8557 

12/04/2012 

1  L—l  V/T7  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1 V  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

ANNE  MUTASHI 

I  \  1  vj  I  V!  l__  l  v  1  V/  1  1  \      1  1 1 

FIRST  VERSION  FINAL  VERSION  OF  FORM  FDA  356H 

1     III  *_/  1      V  1  1  l  Vw/  1  Vw/  1*1,    1     1  1  N  i  \  1—    V  1  1  I  Vw/  1  Vw/  1  VJ    Vw/  1       1    Vw/  1  1 1  V 1    1    L/  / \  OJUI  1 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HOGAN  LOVELLS  LLP 

2012-8558 

12/04/2012 

1  C-l  \J'-rf  C—\J  1  t— 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  I  \i  Vw/ 1  v  1 1     1  /  V/  L/  1  1  1/  V/  III    /  1— '  1 1— '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  MUTASHI 

1  \  1  il  1  N  1       1  v  1  \J  1  / V  v  )  I  1 1 

HOGAN  LOVELLS  US  LLP 

MARINOL  NDA  18-651  DESYREL  NDA  1 8-207  BUPRENEX 

1 V  1 1  \  1  1  1 1  N  Vw/  1       I  M  L/  / V    IV/   UJ  1  t    L/  1  w  1  1  11  L      IN  1  '  n    1  U   L—\JI  .    1  >  V/  1    111  [  vj  I  /  V 

NDA  18-401  -  APRVL  LTRS,  FORM  FDA  356H 

2012-8559 

12/04/2012 
01/03/2013 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      11  \J  1—/  1  1  1/  V/  III    /  \—r  1 1— '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  V/  L/  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  MUTASHI 

1  \  1  il  1  N  1       1  v  1  \J  1  / V  v  '  1  1 1 

HOGAN  LOVELLS  LLP 

CONTROLLED  SUBSTANCES  ACT  -  FDA  DECISION  TO 

v/  Vw/ 1  vi  i  i  iv/ 1  i  i  i  '  w  \j  \  i  u  i  ni  m  v/ 1  v/  / v  v/  i      i  l/  y  \  i_/ 1  v_/ 1  w  i  v_/ 1  vj   i  v_/ 

INCLUDE  ON  THE  FORM  FDA  356H  LANGUAGE  THAT 
APPLIES  TO  PROPOSED  DRUG  SCHEDULING 

2012-8560 

12/04/2012 
01/03/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      11  V/  L/  1  11   1/  Vh/  V/  l_  1  1/  1  /  1    Vw/  1/ 

DANIEL  B  SNELLINGS 

1  / 1  \  1  *l  1  1  I       1  '   \J  1  if  1  1_  1_  1  1  *J  V_H  v_/ 

PENTON  LAW  FIRM 

INTUITIVE  SURGICAL  INC  -  DA  VINCI  SURGICAL  SYS 

1  1  H  1  v/  1  1  1  V  1— —         V/  1  I  V_/  1  V/  /  \  L_    1  1  M  V/  1— /  V  \     V  II  l  V/  1    V/  Vw/  1   I  vi  1  V/ 1  \  I—  O  I  \w/ 

K081207  NOTICES,  CMPLNTS,  MDRS,  ETC 

2012-8561 

12/04/2012 
01/03/2013 

OM/OMP/DODM/ 

KRISTI  0  SMEDLEY  PHD 

Center  for  Regulatory  Services,  Inc. 

DKT  1980N-0218 

2012-8562 

12/04/2012 

OC/OCC/ 

ANDREW  HACK  MD  PHD 

GILEAD  SCIENCES  -  MTG  MINS,  TRANS,  AGENDA,  ETC 
11/8/12 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

01/03/2013 

MILLENNIUM  MANAGEMENT  LLC 

2012-8563 

12/04/2012 
01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      I  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DAVID  C  WEBER 

IS  l  \  V  1  \S    \S    V  V  1—  IS  l__  1  I 

BEHREND  ERNSBEERGER,  PC 

UPJOHN  PHARMS  MUTUAL  PHARM  ROXANE  LABS  - 

\S  1     <J  Vw/  1    1  1  N    [     II  l  \  1  1 1  V 1  Vw/  .    1  V 1  \S  1  V/  /  \  I       1     1   1 1  \  1  1 1  v  1  -    1  I  Vw/  / VV \  1  V|  1        [_/ V  IS 'S 

PREDNISONE  AERS,  LBLG  CHANGES 

2012-8564 

t—\J   1  £—  \J\J\JT 

12/04/2012 

1  C—l  \J  Tl  L—\J  1  i_ 

01/03/2013 

FDA/OGROP/ORA/CE-FO/PHI- 

1    IS  1  \!  \s  \-A  1   V  \-s  1    /  \S  1   1  /  v  \—t  1—    1    Vw/ /  1  III 

DO/PHI-CB/ 

OWEN,  EVAN  D 

MCNEIL  CONSUMER  HEALTHCARE  FORT  WASHINGTON 

1 V  1  Vw/  1  VI  l_  1  l_   Vw/  Vw/  1  >l  \s  V/  1  v  1  1  1  1    1   1  l_  1  \  L_  1  1   1  Vw/ 1  \  1  1 1  j    1    Vw/  III      V  V  /  V  Vw/  1   1  1  1  VI         1  Vw/  1  N  ^ 

PA  -  EIR,  VIDEOS,  IMAGES,  ETC  4/19/12 

2012-8565 

12/04/2012 
01/03/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Yu-Ju  Chiang 

Chung  Yuang  Christian  University 

K033474 

2012-8566 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

Sandy  Stagge 

CTI  Clinical  Trial  and  Consulting 
Servic 

SANDARAM  HARIHARAN,  MEDICAL  COLLEGE  OF 
WISCONSIN  -  483  AND  RESPONSE  (6/12/2000) 

2012-8567 

1  <;/04/^01 
01/03/2013 

rUA/UGHOr/UKA/Ot-rU/OHl- 
DO/CHI-CB/ 

Sandy  Stagge 

CTI  Clinical  Trial  &  Consulting 
Services 

UNIVtKbl  1  Y  Or  CHIOACjU  dIOLOGIOAL  bOltNOtfa  UIVIblUN 
IRB  -  483  AND  RESPONSE  (7/8/2009) 

2012-8568 

12/04/2012 

1  £_/  \JTI  t—\J\l— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/ 1  v  1 1      1  /  V/  L/  1  1  1/  \s  III    /  1 — '  1 1_/  1  / 

TRETINOIN  -  AERS 

1       1       l  1               1       1    1     *l  Vw/   1   1    >J                   1      \  l_  1       l  Vw^ 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \S  IS  1  1  1/  V_/  III    /  (_/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-8569 

12/04/2012 
01/03/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    \—J  / \  1  *!/  Vw/  Vw/  1  / ;  l_  \S  *S/ 

Marvin  Fripdman 

1  v  1  d  1  V  1 1  1    1    1  1      U  1  1  1  C4  1  1 

TR  Services 

CAS  7773-06-0 

V*//  VV — f    1    1    1  yj    \J\J  \J 

2012-8570 

12/04/2012 

1  C—l  \J  Tl  L—\J    1  L. 

01/03/2013 

FDA/OGROP/ORA/SW-FO/DAL- 

1    IS  1  \l  Vw/  V/  1   1  V_/  1    /  Vw/  1  IV  V/  \J  V  V     1    V_//  L/  /  V  1_ 

DO/DAL-CB/ 

Fdward  W  Skpnnpk 

1_      VV  CI  1  \J    V  V    \J  [  Vtj  1— i  \  1  \-i  |\ 

VALNET  INC 

MEDIVATORS  CONROE  TX  -  EIR  (04/03/2010  -  04/15/2010} 

1 V  1  1  IS  1  v  1  \  1  Vw/  1  I  VwJ  ,  Vw /  Vw/  1  N  1  I  Vw/  l_  .     1  /  V        l_  1  1  l    l  V/   i^/  \J\Jt  C—\J  1  V/        V/  1/    1  v//  L_  V/  1  \J  f 

2012-8571 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Christopher  M.  Brown 
Remington  Medical,  Inc. 

REMINGTON  MEDICAL,  INC,  ALPHARETTA,  GA  -  EIR 
(10/19/10-12/17/10) 

2012-8572 

12/04/2012 

1  £_/  V  "T/  L_  W  1  L. 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  !_/  1  ]  /  1  / 

Rqphpl  Johnson 

1   ICIV-'I  1  V/  \              II  IOUI  1 

NDA  22580 

1  *J  IS  1  \   L—  C—  \J  V/  \J 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-8573 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

\S\s!  \S  1  \  !   \^/\s)/ 

Edward  W  Skepnek 
VALNET  INC 

MEDIVATORS,  CONROE,  TX  -  EIR  (02/15/2009  -  03/15/2009) 

2012-8574 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Cindy  Ingold 

AMERICAN  RED  CROSS  BLOOD 
SERVICES 

AMERICAN  RED  CROSS  MISSOURI/ILLINOIS,  ST  PETERS, 
MO  -  EIR  10/27/11 

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 1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

2012-8575 

12/04/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

Glenn  Irish 

pi  1  m  1 —     IK  1  /~>     |    rviK  1  /""•» ~T/~\  ki     i  «  a         inn  1 A  f\  /O  A  /O  f\  4  ^         4  4  ZOO.  /OO  H  o\ 

SHIRE,  INC,  LEXINGTON,  MA  -  483  (10/30/201 1  -  1 1/30/2012) 

01/03/2013 

DO/NWE-CB/ 

Glenn  Irish  Consulting 

2012-8576 

■i  f~\  lf\  A  /OA  ^  O 

FDA/OGROP/ORA/CE-FO/NWJ- 

Ben  Eisler 

ME  1  (JPKOLOL  bUCGENA  1  E,  FUKUbtMIDE, 

f\ H  if\ o  /o  n-(  o 

01/03/2013 

DO/NWJ-CB/ 

CBS  This  Morning 

LEVERTIRACETAM,  ETC  -  AERS,  BIOAVAILABILITY  RECS, 

FDA/OMPT/CDER/ORP/DIDP/ 

INSPECTION  RECS,  ETC 

FDA/OM  PT/CD  E  R/OR  P/D I  DP/ 

1    i  '  / V/  Vw/ 1 V  1 1      1  /  \_/  1— •*  1  1  1/  V- /  III    /  l_/  1  L>  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/CE-FO/BLT- 

DO/BLT-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

n/*\iiii\/i/  i~\/~in/ 

DO/NYK-DCB/ 

FDA/OGROP/ORA/SE-FO/NOL- 

DO/NOL-CB/ 

2012-8577 

12/04/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

John  Crewdson 

SHINGLES  PREVENTION  STUDY  -  INVESTIGATIONS, 

W  1  l\J\JI  C-\J  1  O 

FDA/nMPT/nnFR/DRP/nmp/ 

i  \—Jf\/  v_/ivi  i   i  /  \_/ 1_/  r__  n/  v,/ 1  1 1  / 1_/ 1 1_/ 1  / 

PRO  IFHT  ON  OOVFRNMFNT 

I    n\_/u  1  w  1    V_/l  >l  \J      V  1  1  1 1  N  1 V 1 1  1  *J  1 

AUDITS 

FDA/OMPT/CDER/ORP/DIDP/ 

OVERSIGHT 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 

ALFB/ 

FDA/OGROP/ORA/CE-FO/MIN- 

DO/MIN-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

FDA/OGROP/ORA/SE-FO/FLA- 

DO/FLA-CB/ 

FDA/OGROP/ORA/bW-FO/DEN- 

DO/DEN-CB/ 

2012-8578 

12/04/2012 

FDA/OF/CFSAN/OCD/EOS/ 

BOOST-ULTRA  -  ANALYSIS 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

KANT,  KRISHNA 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  W  l_/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

2012-8579 

12/04/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

BRENDA  M  GARTZ 

ROCHE  CAROLINA  INC,  FLORENCE,  SC  -  483  1/27/10 

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Subject 

01/03/2013 

DO/ATL-CB/ 

ELI  LILLY  &  CO 

2012-8580 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

BRENDA  M  GARTZ 

IS  1  1 1__  1  VI  IS  I  \   1  v  1    \-A  1  VI   1  1  C  

ELI  LILLY  &  CO 

MICROBAC  SOUTHERN  TESTING  RESEARCH  DIVISION 

1 V  1  1  V/  1  I  Vw/  IS  1  \  Vw/   \J  \s  VwV  1  1   1  1  1  11  N     1  1— —  V»J  1  1  1  >J  V_/    1  1 1  \s  1—  1  V 1  1 V/  1   1    L/  1  V  1  \S  1  V_/  1  VI  ^ 

WILSON,  NC-EIR,  483  2/10 

2012-8581 

12/04/2012 
01/03/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

DPT  LABS,  SAN  ANTONIO,  TX  -  EIR,  483  10/18/10-11/12/10 

2012-8582 

12/04/2012 
01/03/2013 

FDA/OMPT/CTP/OD/ 
FDA/OC/OES/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

ROTATIONAL  WARNING  PLANS  FOR  SMOKELESS 
TOBACCO  PRODUCTS  SUBMITTED  BY  ALTRIA  CLIENT 
SERVICES,  PHILIP  MORRIS  USA,  US  SMOKELESS  TOBACCO 
COMPANY  LLC  ETC 

2012-8583 

12/04/2012 
01/03/2013 

FDA/OF/CFSAN/OCD/EOS/ 

STEPHEN  J  WEIN  ESQ 

BATTAGLIA  ROSS  DICUS  &  WEIN 
PA 

ZERXIS  PHARMS  -  METANX,  CEREFOLIN,  DEPLIN,  ETC 
CORR,  SUBMISSION 

2012-8584 

12/04/2012 
01/03/2013 

FDA/OF/CFSAN/OCD/EOS/ 

STEPHEN  J  WEIN  ESQ 

BATTAGLIA  ROSS  DICUS  &  WEIN 
PA 

VIRTUS  PHARMACEUTICALS  LLC  -  METANX,  CEREFOLIN, 
DEPLIN  ETC  CORR  SUBMISSIONS 

\S  1  1     l  1  1  N  ,    l_  1  V/    V/  Vw/  III   I ,    \S  \S  IS  1 V  1  1  *S  \S  1  Vw/  1  VI  *s 

2012-8585 

12/04/2012 
01/03/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Stephen  Slavens 
GE  Healthcare 

K052345 

2012-8586 

12/04/2012 

1  C—l  \J Tl  C—\J\L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      11  \J  \S  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

Kim  Graves  CRNA  ACNP  MSN 

1  \1 1  1  1  V— 1  1  CI  V      O   V/  1  1 1  HI  \  .    fWS  INI     1    1  V 1  *S  1  *J 

PROPOVEN - AERS 

1     1  I  Vw/  1     V/  V  1— —  1  *J        1  \  1  1  I  \S 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \  '  IS  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Dayton  Gastroenterology 

2012-8587 

12/04/2012 

1  C—l  \J "T/  LU  1  L 

01/03/2013 

FDA/OMPT/CTP/OD/ 

1    IS  1  \l  \w/  1  v  1  1      1  /  \w/  1  1    /  Vw/  L/  / 

Rarhpl  Johnson 

1  IdOl  1  V— '  1   UWI  II  IOUI  1 

FOI  Services,  Inc. 

SUBSTANTIAL  EQUIVALENCE  FOR  TOBACCO  PRODUCTS 

\S  Kj  IS  Vw/  1  /  VI  VII 1  V 1       1  V_x  \S  1  V  1  V 1  1  1  VI  V/  1— —    1    Vw/  1  1     1  V/  L//\  Vw/  V/  Vw/    1     II  V_/  L/  V/  V/  1  V/ 

2012-8588 

12/04/2012 
01/03/2013 

FDA/OC/OES/DFOI/ 

Karen  Troutman 
Dewey  Publications  Inc. 

ORGANIZATIONAL  INFORMATION 

^01^-8589 

1  aQAISjM 
01/03/2013 

rUA/Ur/OrbAN/UGD/tUb/ 

b  1  trrltN  J  WtIN  tbU 

BATTAGLIA  ROSS  DICUS  &  WEIN 
PA 

BKtOKtNHIUGt  rHAKMAL/tU  1 IOAL  INO  -  Mt  1 ANX, 
CEREFOLIN,  DEPLIN,  ETC  CORR,  SUBMISSIONS 

2012-8590 

12/04/2012 

1  C-l  \J'-ri  L-\J  I  C- 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \i  Vw/ 1 V  1 1      1  /  \J  IS  1  1  1/  \s  III    /  L/  1  IS  1  / 

Kpvin  Kpnnpv 

■  \    vim  I  \c  i  ii  icy 

INDIVIDUAL  SAFETY  REPORTS 

1 1  M  IS  1  V  1  IS  UrlL  V/ 1  \  1     1       1     1     III  1    Vw/  1  I  1  V  ) 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ENDO  PHARMACEUTICALS 

2012-8591 

12/04/2012 
01/03/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Richard  0.  Wood 

the  Wood  Burditt  group 

CDRH  513(G)  C033022 

2012-8592 

12/04/2012 

FDA/OF/CFSAN/OCD/EOS/ 

STEPHEN  J  WEIN  ESQ 

PAMLAB  LLC  -  METANX,  CEREFOLIN,  DEPLIN,  ETC  CORR, 

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Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

01/03/2013 

BATTAGLIA  ROSS  DICUS  i 
PA 

xWEIN  SUBMISSIONS 

2012-8593 

12/05/2012 
01/04/2013 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  Vw/  1 —  \J/  \—r  1    VwX  1/ 

Joan  Stitt  (UG2CD-16} 

v/V/Clll    WLILL    I  V/  V/  £_  Vw-/  l_/     1  VI 

MERCK  &  CO.,  INC. 

2012-7694  REQUEST  LETTER 

2012-8594 

12/05/2012 

1  t—l  \J\JI  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   IVJVJLULf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7715  REQUEST  LETTER 

2012-8595 

12/05/2012 
01/04/2013 

FDA/OC/OES/DFOI/ 

1  1— fi\l  V/ V//  Vw/ 1 — \JI  1— '  1    V_/  1/ 

Joan  Stitt  (UG2CD-161 

UVJO.II  w  LI  L  L  y  vJ      C  W  L/    1  vj  y 

MERCK  &  CO.,  INC. 

2012-7506  REQUEST  LETTER 

LU  1  L    1  \J\J\J  ll  1  Vx  VJ  1  w  1     1  1      1    II  11 

2012-8596 

12/05/2012 
01/04/2013 

FDA/OC/OES/DFOI/ 

1    L//V/  V_/V_//  V_/l — O/  \-J  1    V_/ 1/ 

Joan  Stitt  CUG2CD-16^ 

uUal  1  wLHL  ^UVJt.V/U    1  \J y 

MERCK  &  CO.,  INC. 

2012-7769  REQUEST  LETTER 

t—  W  1  C    1   1  \J\J    I  \  1  Vj<  w  1  w  1     1  1      1    II  11 

2012-8597 

12/05/2012 

1  C—l  \J \JI  L—\J\L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7782  REQUEST  LETTER 

L—  \J   1  L—     1    1  V/  L—    1    I  1  V_a<  V/  L_  Vw/  1      1  l_  1     1    1  1  1 

2012-8598 

12/05/2012 

1  C—l  \J \JI  L—\J\L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

U</Ul  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-7784  REQUEST  LETTER 

L_ \J    1  L—      1     1    V/     1      1    1  1  VX  V/  1  \-J    1       1  l_    1      1    1  1  1 

2012-8599 

12/05/2012 

1  t—l  \J\JI  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

uUul  1   WLIIL   1  VJV^l.V/L/     1  V/  1 

MERCK  &  CO.,  INC. 

FOI  DAILY  LOG  11/1-30/2012 

1    Vw/  1    L/  /  VI  1       1     L_ Vw/  V^l       1    1  /    1     \J\JI  t—  \J  1  t— 

2012-8600 

12/05/2012 

1  t—l  \J \Jl  t—  \J  1  t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

\J\JCLl  l   WLIIL    IUV<luV/L/  / 

MERCK  &  CO.,  INC. 

CLOSED  FOIA  REQUESTS  11/1-30/2012 

Vw/ 1_  Vw/  Vw/  1  L_/    1    V_/  1  /  V   1  1 1__  V_x  V/  1  V_/  1  O     1    1/    1     O  V//  L-  V/  1  l_ 

2012-8601 

12/05/2012 

1  t—l  \J\Jl  L—\J\S— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl    1  V/V-tLV/L/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7734  2012-7736  201 2-7737  REQUEST  LETTER 

£_  V/  1  £—     1   1  \-J    l  •    L_  V/  1          /    /  v/  V/ ,    L—  \J  1  L—     1    1  \J  1     11  L_\hX  VJ  1—  v_/  1     1  l__  1    1  l_  1  1 

2012-8602 

t—\J  1  C—    \J\J\J t— 

12/05/2012 

1  t—l  \J \Jl  t—\J\i— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

\J\JCLl  l   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-7641  REQUEST  LETTER 

L—  \J  1  t_     /  \J   T  1     11  1  VX  V/  1  1     1  l__  1    1  1  1  1 

2012-8603 

12/05/2012 

1  t—l  \J\JI  t—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 
MERCK  &  CO.,  INC. 

2012-7509  REQUEST  LETTER 

£_  V/  1          /  \_/  V/  *_/    11  1  VX  V/       Vw/  1     1  l__  1    1  1  1  1 

2012-8604 

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1  t—l  \J \Jl  t—\J\i— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

U</Ul  1    WLILL    IVJVJLWL/  / 

MERCK  &  CO.,  INC. 

2012-7693  REQUEST  LETTER 

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2012-8605 

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1  t—l  \J\Jl  t—\J\C— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

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MERCK  &  CO.,  INC. 

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2012-8606 

12/05/2012 

1  t—l  \J \JI  L—\J\L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

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2012-8607 

12/05/2012 
01/04/2013 

FDA/OC/OES/DFOI/ 

Joan  Stitt(UG2CD-16) 
MERCK  &  CO.,  INC. 

2012-7239  REQUEST  LETTER 

2012-8608 

12/05/2012 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16) 

2012-7403  REQUEST  LETTER 

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2012-8609 

L—\J    1  C—     \J\J\J  \J 

12/05/2012 

1  i—  I  \J \Jl  L—\J\L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   wLIlL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-7497  REQUEST  LETTER 

L—  \J    1  L—      1       1^  v/  /       11  1  VX  Vw^  1                 1       1  l_    1      1    1        1  1 

2012-8610 

12/05/2012 

1  t—l  \J\Jl  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  11 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   IVJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-4131 

2012-861 1 

12/05/2012 

1  t—l  \J \Jl  L—  \J  1  t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L>  1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-7026 

2012-8612 

12/05/2012 

1  t—l  \J\Jl  L—\J    l  L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

UUCll  1    WLILl   1  VJVJLV/L/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7444  REQUEST  LETTER 

2012-8613 

fc-V/    1  t—    \J\J  1  >— ' 

12/05/2012 

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FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
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2012-7064   REQUEST  LETTER 

L—  \J   1  L—     1   \J  V/    1^         1    I  l_  \j  K-J  \  U   1      1  1        1     1    1  1  I 

2012-8614 

12/05/2012 

1  t—l  \J\Jl  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    WLILl   IVJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-6950 

t—\J  1  £_  UviJU 

2012-8615 

12/05/2012 

1  t—l  \J \Jl  L—\J\L— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  11 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7016 

2012-8616 

12/05/2012 

1  t—l  \J\JI  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

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MERCK  &  CO.,  INC. 

2012-7198  REQUEST  LETTER 

2012-8617 

L_  \_/  1  £_    L/V/  1  / 

12/05/2012 

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FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-6436 

C—\J  1  i—   V/  ^  v/  \J 

2012-8618 

12/05/2012 

1  t—l  \J\Jl  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    WLILl   1VJVJLV/L/     1  \J  I 

MERCK  &  CO.,  INC. 

2012-6382 

£_  V/  1  L—  \J\J\jt— 

2012-8619 

12/05/2012 

1  t—l  \J \JI  t—\j\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-6538 

L_  V/    1  t—  \J 

2012-8620 

12/05/2012 

1  t—l  \J \JI  t—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7189  REQUEST  LETTER 

t—\J\t—    1    \  \J\J  I  \  \  Vj(U  1  w  1     1  1       1    II  11 

2012-8621 

12/05/2012 

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01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7468  REOUEST  LETTER 

LU  1  L    /  TUU  ll  1  VXU  1  \J  1     1  1      1    II  11 

2012-8622 

12/05/2012 

1  t—l  \J xjl  t—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7199  REOUEST  LETTER 

t—  W  1  t—    1    1  \J  \J  1  1 1  VXU  1  \J  1     1  1       1    II  11 

2012-8623 

12/05/2012 

1  t—l  \J \JI  L —  \J    1  t— 

01/04/2013 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

HOLLISTER-STIER  (JUBLIANT),  SPOKANE,  WA  -  EIRS  2/12 

2012-8624 

12/05/2012 
01/04/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

PATHEON,  CINCINNATI,  OH  -  EIRS  12/11,7/12 

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2012-8625 

12/05/2012 
01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 

LJ 1  II  1  NLT\   Ivl    VJr\l  I  1  t— 

ELI  LILLY  &  CO 

HISUM  PHARMACEUTICAL  COMPANY  LTD  ZHEJIANG 

i  mouivi  i    i  1 1  v  i  iivi/\\_/i  \j  i  iwni     v_yv_/ivii   ni  m  i    i     i  i_/  n  i_i  ii  yini  \i\/] 

CHINA -EIRS  9/11,7/12 

2012-8626 

12/05/2012 
01/04/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

INIUITIVE  SURGICAL  INC,  SUNNYVALE,  CA  -SURGICAL  SYS 
&  ENDOWRIST  K050369,  RESP  LTR  4/29/05  (CERTIFIED) 

2012-8627 

12/05/2012 
01/04/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

M  MELISSA  BALTZ 
BUTLER  SNOW  ET  AL 

DA  VINCI  SURGICAL  SYS-  DAVINCI  SURGICAL  SYS 
ENDOSCOPIC  INSTRUMENTS  K043288,  RESP  LTR  3/3/05 
(CERTIFIED) 

2012-8628 

12/05/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

CHANDRAN  TIRUVATTAR 

WARNER  CHILCOTT  US  -  ESTRACE  ANDA  08-069  SBA 

01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/DFOI/ 

DR  REDDY'S  LABORATORIES 

i  J  i  i  i  1 1  i  *  \  /  i   v»j  i_y  \  i—/  Vw/ 1  ii  \  i  Vw/ 1  1 1 1  K-i 

INC 

2012-8629 

12/05/2012 

1  t—i  \J\JI  t—\J  1  t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

CHANDRAN  TIRUATTAR 

v/ 1  1 1  \  \  >i  i_/  i  i  y  \  ix    i  1 1  i  v/  /  \  i   i  /  \  i  i 

VALEANT  INTL  -  ZOVIRAX  NDA  18-604  SBA 

V  1  \ l—  l—  1  \  1  1  1      IM  1  L        t-  Vw/  VII                 1  X  l—S /  \     1  \J    \J\J^   \J  1  '  1  \ 

01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DR  REDDY'S  LABORATORIES 
INC 

2012-8630 

12/05/2012 
01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    )  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  l_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

JACKSON,  EVA  JO 

ENALAPRIL  MALEATE  METROPROLOL  NORTRIPTYLINE 

1  1  HI  \  1  1  \  1     1  1 1  L*.   1  V  1 1  \  1  1  t  \  1  1  1    Ivl  1       1  1  1  Vw/  1     1  I  Vw/  L_  Vw/  1  ^    1  >J  Vw/  lllllll      1     1            v  1  

HCL,  ETC  -  RECALL  RECS,  PI,  AERS,  ETC 

2012-8631 

12/05/2012 
01/04/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

ANDREA  CLISURA 
FARUQI  &  FARUQI  LLP 

CMPLNT  29667 

2012-8632 

12/05/2012 
01/04/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Doe  J 

CAMPBELL  -  CREAM  OF  SHRIMP  SOUP  CMPLNT 

2012-8633 

12/05/2012 
01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  I — /  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MARIAH  MONTGOMERY 

i  v  1 1  \  \  1 1 1  v  i  i  ivi  Vw/ 1  *j  i  v/  \w / 1  v  1 1  i  i  i 

CHANGE  TO  WIN 

ALMUS  PHARMACEUTICALS  SINGAPORE  PTE  LTD' 

/  \  I  1  V 1       \-J    1     1   1 1  \  1  1 1  VI/  \  Vw/  1  kw7  1  1  V_/ 1  \  \  V_J  1  1  M       /  \  1     Vw/  1  1 1        1      1  1        1       1  1 — '  , 

IMPORTS  REFUSALS,  EIRS,ETC  2005  TO  PRESENT 

2012-8634 

12/05/2012 
01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

MARILYNN  WHITNEY 
COVINGTON  BURLING  LLP 

CAFFEINE  INTAKE  BY  THE  US  POPULATION  9/09 

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/"V  1  1  If 

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2012-8635 

12/05/2012 
01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

VERONICA  S  KNAPP 

V  1  1  1 VJ 1  >l  1  VJ 1  V  vj    1  \l  *•  / V 1  1 

HOGAN  LOVELLS  US  LLP 

SE  RICHARD  J  DURBIN  CAFFEINE  INTAKE  BY  US 

*_>  1        III  W  1   1 1  \  \  1  \—f   \J    ]—/  VJ  1  lt—f  MM,    V-*/\  1     1    1  1  1  N  1        1 1  VI  1  1  \  1  \  1        l—f  1           '  ' 

POPULATION  9/09 

2012-8636 

L—\J    1  L—  \J\J\J\J 

12/05/2012 

1  L—  1  \J \JI  L—  \J    1  t— 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  1  \i  Vw/  1    /  w  1  ^— //%  1  VI/  \w/  Vw/  1 — /  /  l_  Vw/  u/ 

Dp^mnnnp  Rpnnptt 

L/t7  0l  1  1 V/ 1  1 1  1  v»>    E-J  ^7  1  1 1  1  V_-  L  L 

BRYAN  CAVE  LLP 

ONE  COCONUT  WATER  ONE  WORLD  ENTERPRISES  ONE 

Vw/  .  1  M  .  1  .    Vw/  Vw/  Vw/  Vw/  1  VI  Vw/  1      V  V  /  V  II  11,    Vw/  1  VI 1        V  V  \_/  1  1 1— l—f    1  1  N  1   1  111     111  w  1  w  ,    \_/  1  M  1  

NATURAL  EXPERIENCE  -  CAERS  (03/01/2008  -  12/04/2012) 

2012-8637 

12/05/2012 

1  t—l  \J\Jl  L—\J\t— 

ORA/ 

Nathan  Rallard 

1  Null  lUl  1  1 — ' CI  1  lul  U 

SAMPLE  RESULTS 

\wi/\IVII    1  1       1  11  UUL  1  >  ' 

01/04/2013 

ORA/ 

Sunrise  Produce  Inc. 

2012-8638 

L—\J  1  L—  UUuU 

12/05/2012 

1  t—l  \J \JI  L—\J\L— 

01/04/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Fdward  W  Skpnnpk 
VALNET  INC 

FLEX  MEDICAL  ASHEVILLE  NC  -  EIR  03/31/201 1 

i  i  i  y\  i  v  1 1  I—/ 1  Vw/ 1  \  l  ,  r\w  i  ii  vii  i  i  ,  i  n  w      i  ii  i         \j  i  /  C—\J  i  i 

2012-8639 

12/05/2012 

1  t—l  \J\JI  L—\J\t— 

01/04/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  LJ  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUul  1   WLIIL   1  VJ\^Il.V/L/     1  \J  j 

MERCK  &  CO.,  INC. 

2012-7056   REQUEST  LETTER 

L—  \J    1              /    \J  \_t  \J           1    I  l_  \J  Vw^  1  \_l    1       \  1          1      1    1        1  I 

2012-8640 

12/05/2012 

1  t—l  \J \JI  t—\J\C— 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  \w/  1    V//V  1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Fdward  MrPikp 
Stifel  Nicolaus  &  Co 

ENERGY  DRINKS  -  FULL  CAERS  REPORTS  LISTED 

1  1  N  1  1  1  \-A   1      l—f  1  1 1  1  VI  1  \\J        1    Vw^  l_  1       \S  1  \  \  1  I  Vw/    1  1 1_  1     Vw/  1  1  1  U    1—  1  V-^  1  1— —  l — ' 

2012-8641 

12/05/2012 

1  t—l  \J\JI  t—\J  1  C— 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    ]  /  /  V/  Vw/  1    /  Vw/  1    VJ /  V 1  HI  Vw/  Vw/  l_//  l_  Vw/  V-// 

Rarhpl  .Inhn^nn 

1  IdVwfl  lul   \J\J\  II  loul  1 

FOI  Services,  Inc. 

FCN  546 

1  Vw / 1  v|    v/  V/ 

2012-8642 

12/05/2012 

1  t—l  \J \JI  t—\J\t— 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  \J  1    'S 1  \  1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Charlp^  5*lnhn 

Vw /  1  1  CI  1  1      O   Vw/  V/  1  II  1 

Sohn,  Charles 

FAP  3B3713 

1    1  V 1       \J            /    1  w 

2012-8643 

12/05/2012 

1  t—l  \j\Ji  t—\j\t— 

01/04/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

i    J  / /  v/  Vw/  vj  i  i  Vw/ 1   /  Vw/ 1  \i  \t  \j  v  v    i          i  w vi 

DO/KAN-CB/ 

David  Manninnp 

lw/  CI  V  1 VJ    1  V IQI  IUIUI  1  v 

FDAZILLA 

HOSPIRA  MCPHERSON  KS  -  483  MO/24/201 2} 

1   1  Vw/  V»J  1     II  1 V  \ ,    1  V 1  Vw/  1     1   1  1  1  l  Vw/  Vw/  1  VI  ,    1  \                 V/  V-/    \    IV//  £l_    l  /  L_  V/  1  L_  f 

2012-8644 

12/06/2012 

1  t—l  \j \ji  t—\j\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ7  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J  1  \  V  1  1 — /    1  v  1  Vm/  1    /  x  1  1 1  /  \  1  *l  1 — / 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  11/19-13/12 

Vw/ 1— Vw/  Vw/ 1  i — f  i   v^/  i  /  v  i  1 1— _  \_k  Vw/  i  u  i  VwJ    i  i  /  i  \j    i  v//  i  C— 

2012-8645 

12/06/2012 

1  t—l  \J\JI  t—\j\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1— /  /  \  V  1  1  /    1  v  1  Vw /  1    /  \  1  1 1  l  \  1  *l  1 — / 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  11/26-30/12 

V/LV/U  L_  l_/    1    Vw/  1  /  V   1  1 1— —  V_x  VJ  1— —  *w/  1  *w/     1    1  /  t—  w    v/  v//    1  L_ 

2012-8646 

12/06/2012 

1  t—l  \j \JI  t—\j\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ7  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

1  1     \  \J  \     l  1         1    ll      Vw/      1  1 1     \  1      ii  i 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REQUESTS  11/19-23/12 

Vw/ 1— Vw/  Vw/  1  (_/    1    V-/  1  /  V   1  1 1— —  \_K  Vw/  1  U  1  VwJ     1    1  1    1  \J    L—  V-//    1  L_ 

2012-8647 

12/06/2012 

1  t—l  \J\JI  t—\j\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  LJ  1    Vw/  1/ 

LAUREN  S  BARR 

1—1  \  V_/  1  1 1  1  VI    v_J  1— '  /  V 1  I J  I 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REQUESTS  11/26-30/12 

V/LV/W  l_  L/    1    Vw/  1  /  V   1  1 1— —  V_x  VJ  1— —  *w/  1  *w/     1    1  /  t—  w    v/  V//    1  l_ 

2012-8648 

12/06/2012 

1  t—l  \j \ji  t—\j\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

CLOSED  FOIA  REQUESTS  11/19-23/12 

Vw/ 1— Vw/  Vw/ 1  i_/  i   V-/  i  /  v  i  1 1_  \j  Vw/  i  VwJ  i  VwJ    i  1 1  i  \j  L—  v//  i  £_ 

2012-8649 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

CLOSED  FOIA  REQUESTS  1 1/26-30/12 

2012-8650 

12/06/2012 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

CLOSED  FOIA  REQUESTS  1 1/9-23/12 

01/07/2013 

FDA/OC/OES/DFOI/ 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

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Signature/  Requester 

Subject 

2012-8651 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOIA  REQUESTS  1 1/26-30/12 

2012-8652 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \     1  / \  1  11  11  V_/  V-/  1  v|    v_/  Vw/  1   1 1  I  /  \  1  v  1 1 

CanReg,  Inc. 

CLOSED  FOIA  REQUESTS  11/19-23/12 

Vw/  LwU  1  L/    1    V_/  1  /  V   1  1 1— —  V_x  V/  1  V_/  1  VwJ     1    1  /    1  \J    t—  V//    1  t_ 

2012-8653 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

CLOSED  FOIA  REQUESTS  1 1/26-30/12 

2012-8654 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  1— /  1  1—/  1  / 

BRENDA  M  GARTZ 

1  '  1  1 1__  1  VI  1  J 1  \   1 V  1    V_/  /  VI   l  1  £  

PATHEON  FERENTINO  ITALY  -  483S  5/1 1  11/11 

1     /  V  1  1   1  1  \w/  IN-    1     1  1  1 1  1  N  1   1  1  *l  V-/  ,    1  1  V \  l       1            i  V/     \J   \JI   1    1  -  11/11 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  l—S  1  l  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2012-8655 

12/06/2012 
01/07/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

PHILIPS  PLASTICS  CORP,  MENOMONIE,  Wl  -  EIRS  1 1/1 1 

2012-8656 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  \—s  1  1  1/  \w/  III    /  1 — '  1  !_/  1  / 

BRENDA  M  GARTZ 

1  f  1  1 1__  1  VI  1  /  1  \   1 V  1    \-A  /  VI  I  1  i.  

BOEHRINGER  INGELHEIM  VIENNA  AUSTRIA  -  EIRS  3/12 

l_J  Vw/  1  1   II  1 1  1  x  \-A  1  11    1  1  V        1  1  1   1  1  1  1  V  1  ,     VI  1  1  N  1  \  1  V  ?    /  V  KJ  Vw/  1  1  1 1  /  \        1  III  v/   V-/  /    1  t— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  \—J  1  1  1/  V_/  III    /  ( — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2012-8657 

12/06/2012 

1  t—l  \J\JI  t—\J\(— 

01/07/2013 

FDA/OGROP/ORA/SE-FO/NOL- 

1    1  /  /  V/  Vw/  \J  1  1 V-/  1    /  Vw/  1  I  /  \i  \J  l__    1    Vw//  1  VI  W  1— 

DO/NOL-CB/ 

PATRICIA  L  REGENYE 

1    1  \  1  1  l  1  V/  1 1  V   l_    1  1 1  1— —  1  VI   1  1  

Celgene  Corporation 

FARRELLL  MENDELSOHN  CARDIOLOGY  PC  BIRMINGHAM 

1    t  \  1  1 1  1 1  1  1  1       1 V  1  1— —  1  *l  J  /  l_  1  K-)  V-/  1   1  1  il  ■    V//i  1  I  L*S  1  Vw/  L_  Vw/  Vwl   1     1     Vw/  ^    1  1  II  I  1  V  1  1  1  VJ        1    1  /  V I  V  1  3 

AL-483S6/04  TO  11/1 2 

2012-8658 

12/06/2012 
01/07/2013 

FDA/0GR0P/0RA/SE-F0/N0L- 
DO/NOL-CB/ 

PATRICIA  L  REGENYE 
Celgene  Corporation 

RICHARD  KRAUSE,  PARKRIDGE  PROF  PLZ  SOUTH, 
CHATTANOOGA,  TN  -  483S  8/06  TO  1 1/12 

2012-8659 

12/06/2012 

1  t—l  \J\Jl  L—\J\t— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    i  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SANJAY  H  SHARMA 

v/ni  vi u i  v  i    i  i  vj i  1 1  \ i  1 1 v 1 1  \ 

HETERO  USA  INC 

MEPRON  (ATOVAQUONE^  ORAL  SUSPENSION  fMEPROM  - 

1 V  1  1  1     11  V_/  1  *l    \  l  \  1  Vw/  V  /  \       V/  Vw/  1  M  1      J    Vw/  1  I  /  V  L_  \w*  Vw/  V/  1  1— —  1  *l  V/  1  Vw/  1  VI    1  1 V 1  1— —  1     11  Vw/  1  x  f 

CHEMISTRY  RVW,  BIOQV  RVW,  ADMINSTRATIVE  RECS 

2012-8660 

12/06/2012 

1  t—l  \J\Jl  t—\J\C— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  11   1/  Vw/ \J  l__  1  1/  1  /  1    Vw/  1/ 

M  MELISSA  BALTZ 

Ivl    1  V  1  1  1  1  V_/  V_/ 1  \   1—}  1  V  l_  1  £.  

AMS  APOGEE  VAULT  SUSPENSION  SYS  K040537 

/  VI V  1         '  \  1     V  '  Vw/  1  1         V  /  \  V/  [_  1     V/  Vw^  V/  1     1  1  N  Vw/  1  Vw/  1  VI    Vw/  1  V/    1  V  W      V/ \_/  v/  / 

01/07/2013 

FDA/OC/OES/DFOI/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      It  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

FDA/OC/OES/DFOI/ 

BUTLER  SNOW  ET  AL 

(CERTIFIED) 

2012-8661 

12/06/2012 

1  t—t  \J  V//  L —  \J   1  L — 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

CHRISTIE  EVANS 
HILL  ROM 

STRYKER  -  IBED  WIRELESS  WITH  IBED  AWARENESS 
K1 03536 

2012-8662 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

WASHINGTON,  MARK  A 

POLICIES  &  PROCEDURES  FOR  THE  GENERAL  DISCHARGE 
OF  ALL  DEBT 

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Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8663 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

GABRIEL  FZAMBRANO 

BOEHRINGER  INGELHEIM  PHARMS  -  PRADAXA  CAPS 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FnA/OMPT/nnFR/DRP/nmp/ 

\  vj  t\i  v_/ivi  \   \  1  \j  is  \  rv  \j  iii  /  \s  1 1— j  \  i 

FARMER  JAFFE  WEISSING 
EDWARDS  FISTOS  &  LEHRMAN 
PL 

(DABIGATRAN  ETEXILATE  MESYLATE)  RECALL  RECS, 
CORR,  NOTICES,  ETC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

2012-8664 

12/06/2012 
01/07/2013 

FDA/OF/CFSAN/OCD/EOS/ 

MICHELE  MITAL 

OLSSON  FRANK  WEEDA 
TERMAN  MATZ  PC 

CAFFEINE  INTAKE  BY  THE  US  POPULATION  -  RPT  9/09 

2012-8665 

12/06/2012 

FDA/OF/CFSAN/OCD/EOS/ 

n  a  ~\ — ri  \  a  /  a  i  i  i —  n 

PATTI  WALLER 

t~\  u  AUDrni  aim  i —  a  ni  no  n  n  /~\    i  ipr  i n  i        o  a  i  h  i\     k  i  i —  i  i  a 

CHAMBERLAIN  FARMS  PRODUCE  INC  -  SALMONELLA 

01/07/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

MARLER  CLARK  ATTYS 

TYPHIMURIUM  AND  SALMONELLA  NEWPORT  MULTISTATE 
OUTBREAK  CORR,  LAB  RESULTS,  TRACE  BACK,  ETC 

2012-8666 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  L- /  1  1  1/        III    /  I — '  1  IS  1  / 

PARAKKAL  DEEPAK  MD 

1    / \  1   1 1  \  1  \  1  \  I  \  1       \S  1  1  1     /  VI  \   1 V 1  IS 

ISRS  3910189  3931338  3931346  ETC  1/03  to  6/12 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  W  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

CENTER  FOR  THE  STUDY  OF 
COMPLEX  DISEASES 

2012-8667 

12/06/2012 
01/07/2013 

FDA/OF/CFSAN/OCD/EOS/ 

DIANNE  L  CHAMBERS 
HOGAN  LOVELLS  US  LLP 

DKT2012F-0480  -  FAP 

2012-8668 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

ELLIOT  FAVUS  MD 

FAVUS  INSTITUTIONAL 
RESEARCH  LLC 

HEARTWARE  VENTRICULAR  ASSIST  SYS  -  MDRS 

^01^-8669 

1<;/06/^01<; 

UKA/OHM/ 

(jAIL  LtSSIOK 

UUMtS  1 IU  ANU  FUFitKjN  UKUb  GUMPANItS,  MtUIL-AL 

01/07/2013 

ORA/ORM/ 

LACHMAN  CONSULTANT 
SERVICES  INC 

DVC  MFRS  BIORESEARCH  MONITORING  (BIMO^  ETC  - 

IS  V  W    1  V  1  1     11  Vw^  j     IS  1  Vw/  1    l  l__  \S  1—  1  V  1    l  > — /  1    1    1  V  1  \S  1  *l  1    1    \S  1    I  1  1  *l  \v4    \  1  ^  1  1  V  1  Vw/  /  ,     1        1  w 

INSPS  10/1-31/12 

2012-8670 

12/06/2012 

ORA/ 

PURINA  DOG  FOOD  -  ALUMINUM  POISONING  CMPLNT 

01/07/2013 

ORA/ 

Doe  J 

2012-8671 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

TERAZOSIN,  HYTRIN  -  AERS 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

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/"V  1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8672 

12/06/2012 

FDA/OC/OES/DFOI/ 

BRODY  MULLINS 

SAC  CAPITAL,  CR  INTRINSIC  -  RECS,  CORR  1/1/05  TO 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

WALL  STREET  JOURNAL 

12/1/12 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/ 1  \l  Vw/  1 V  1  1      11  \  '  L/  1  11   1/  V-/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

OC/COS/OES/ 

OC/COS/OES/ 

v_/\_//  Vw/  Vw/  v — '/  \w/ 1 —  v — f/ 

OC/COS/OL/ 

2012-8673 

12/06/2012 

OC/OM/OMP/DDM/ 

V_/ \J1  Vw/  1 V 1/  Vw/  1  v  1  1    /  1 — /  1 — '  1  V 1/ 

COLLEEN  CAMPBELL 

Vw/  \  '  l_  L_  l_  l_  1  VI    Vw/  /  V 1  V  1  1     1  '  l__  1  1  

DKT  1998P-0610 

l  /  i  \  i     i  \j  \j  \J  i      \J\J  1  \J 

01/07/2013 

SIDLEY  AUSTIN  LLP 

ORA/ 

RANRAXY  -  MFDinATIDN  nDNTAMINATIDN  P.MPI  NT 

1          >l              I        1 V 1 1  !_/  1  Un  1  1  V_/ 1  N  v_/ V_/ 1  M  1  rAI  VI 1 1  >J  f  \  1  1  v_/ 1  \J  v_/  IV 1  H  1—1  M  1 

01/07/2013 

ORA/ 

Doe  J 

2012-8675 

12/06/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1 1  i  r~\\/  t~  /"^/"n  n  r^/™\N  i        /h  a 

JUDY  F  GORDON  DVM 

TRUEVIblOIN  SYSTEMS  INC  -  K101861 

01/07/2013 

FDA/OC/OES/DFOI/ 

CLINREG  CONSULTING 

SERVICES  INC 

^01^-8676 

1<;/06/<;01<; 

UC/U  M/UM  r/ U  U  M/ 

1  HOMAS  rl  1  ZGtHALU 

UK  I  1985N-0548,  1976G-007o 

01/07/2013 

FSI  RESEARCH  &  SERVICES, 

INC. 

2012-8677 

12/06/2012 

1  £_/  W  V//  LU  1  L 

FDA/OMPT/CDRH/OCER/DFOI/ 

1          IS  1      \i    \w/  1  V  1   1             1     /    \m/  L/   1       11       1/    V_/  \w /  l_  |       1/     1  /   |         Vw/  1/ 

Virninia  Anplln 

V  11  \A  1  1  II  CI  #\l  1  Vs  1 1 V/ 

K8231 15 

1  \  V/  £_  O  1    1  v/ 

01/07/2013 

DOUGLAS  &  LONDON 

2012-8678 

12/06/2012 

1  t—l  \J\JI  S—\J\t— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    J  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/ \J  1—  1  1/  1  /  1    Vw/  1/ 

Virninia  Anplln 

v  ii  Vwj 1 1  ii ci  1  y i  ivi i v/ 

K852310 

1                       1  V/ 

01/07/2013 

DOUGLAS  &  LONDON 

FDA/DMPT/nnRH/nnFR/nFm/ 

i  \—jf\/  v_/ivi  n  i  /  \j  lj  rii  i/  v_/  \_/ 1  i  i/  L/  n  v/ 1/ 

\/irninip  Anpllrj 
v  1 1  y  1 1  ii d  r\\  i c 1 1 u 

Kn7f)177 

01/07/2013 

FDA/OC/OES/DFOI/ 

DOUGLAS  &  LONDON 

2012-8680 

12/06/2012 

1  t—l  \J\Jl  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/ 1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

Annplia  Slavtnn 

i  \  i  iy  vj  i  i  ci  v/ 1  ca  y  iv/ 1  i 

NYCOMED  GMBH  BADEN-WUERTTEMBERG  GERMANY  - 

1  M    1  V/  Vw/  1 V 1  1— —  L/          1 V 1  1  '  1   1  ,    1—/ 1  V  L/  l_  IN     V  V  Vw/  l_  III     1  l_  1  V 1 1— J  1  1  I  Vw/  j    Vw/  1  1  1 1  v  1 1  V 1  VI  1 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

INC  RESEARCH  CONSULTING  X 

1 1  V]  V/    1  1 1  v_>  1  7  \  1  l  V_f  I   I    V/  Vw/  1  M  \w>  V/  1       1   1 1  \|  \_A  vx 

EIR  (04/19/12) 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L*/  1  J  /  1  / 

SUBMISSIONS 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8681 

12/06/2012 

0C/0ER/0PA/ 

XIN  GE 

DR  SHIMIN  FANG  -  RECS  RE  INVITATION  TO  SPEAK  AT 

01/07/2013 

INDIVIDUAL 

FDA  ON  11/10/12  SPEECH 

2012-8682 

12/06/2012 

0M/0MP/D0DM/ 

Mehul  Govani 

1995-S-0039 

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PL  DEVELOPMENTS 

2012-8683 

L—\J  1  C—  UUUu 

12/06/2012 

1  C—l  \J  \Jl  L—\J\L— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \l  Vw/  1  v  1  1      1  /  \J  \—J  1  1  1/  \-s  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \!  Vw/  1  v  1  1      11  \  '  IS  \  1  1/  \S  III    /  IS  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Anna  Fdnpv 

l  \  1  II  ICl    1_ \JK  1  1  v/  V 

BLOOMBERG  NEWS 

SIDNEY  GILMAN  -  FINANCIAL  DISCLOSURE  FORMS 

Vw^  i  is  i  vi  i_  i    v_h  i  ^i  v  1 1  \  i  vi       i    1 1  vi  I  \  i  vi  v/  i  /  v i_  i — '  i  v_/  v/ 1_ Vw/  Vw/  v_/  i  1 1       i   \s  i  1 1  v  i  Vw^ 

(01/01/2002-  12/05/2012) 

2012-8684 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \  '  IS  1  11   1/  \S  \S  1— —  1  1/  \S  1    \S  11 

KYOCERA  Meriiral  Cornoration 

E  \  1  Vw/  V/  1  1  L  V  \    1  V  1  \J  \-A  1  O  CI  1    V/  V/  1  k/  V/  1  CI  L 1 V/ 1  1 

KYOCERA  Medical  Corporation 

K01 1533 

1  V  V/  1    1  \J\J\J 

2012-8685 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Virginia  Anello 
DOUGLAS  &  LONDON 

K922005 

2012-8686 

12/06/2012 
01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  \  1  1/  \S  III    /  \S  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  IS  \  1  1/  > — /  III    /  IS  1  IS  1  / 

OM/OMP/DODM/ 

Jennie  Laton 

HASSARD  BONNINGTON  LLP 

1   1 1  \  V/  \S  I  \  1  l  IS    IS  Vw/  1  >l  1  il  1  1  V  V_H  1  Vw/  1  >l    1_  L_  1 

SKIN  BLEACHING  OTC  DRUGS  -  PROPOSED  RULE, 
TENTATIVE  FINAL  MONOGRAPH,  NOTICE  OF  PROPOSED 
RULEMAKING,  ETC 

2012-8687 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  L-/  1    Vw/  1/ 

MARY  SCHWAGER 

i  vin  i  i  i    v/  v/ 1  i  v  v  i  \ \~a  i  i  i 

WHDH-TV  INC 

AIRLINE  CATERERS  -  INSP  LAST  3  YRS 

1  \  II  1 1_  1  1  ^1  1        Vw/ 1  \  1  1  1  1 1  1  l  V/        1  1  VI  V/  1       l_/  \  v^/  1     v/     III  V/ 

2012-8688 

12/06/2012 

1  t—l  \J\JI  L—\J\t— 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  \w/  V/  l_  1  1/  IS  1    Vw/  1/ 

Virninia  Anplln 

V  II  \A  1  1  II  d  /  \  1  1^1 1 V/ 

DOUGLAS  &  LONDON 

K030497 

2012-8689 

L—\J    1  L—  \J\J\J\J 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  IS  1    Vw/  11 

Virninia  Anplln 

V  II  \A  1  1  II  CI  #\l  IUI 1 V/ 

DOUGLAS  &  LONDON 

K810925 

1  V  V/  1  V/  \J  t—  \J 

2012-8690 

12/06/2012 

1  t—l  \J\JI  L—\J\t— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

KRISTI  O  SMEDLEY  PHD 

1  V  1  11  Vw/  1  1    Vw/    V/  1 V 1  1— —  L/  1  l_  1     III  IS 

Center  for  Regulatory  Services,  Inc. 

201 1-9188 

t_  V/  11    \J  1  v/  V/ 

2012-8691 

L—\J    1  L—    \J\J\J  1 

12/06/2012 

1  t—l  \J \Jl  L—\J\L— 

01/07/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L-/  1    Vw/  1/ 

KRISTI  O  SMEDLEY  PHD 

E  \  1  11  Vw/  1  1    Vw/    V/  1 V  1  1— —  L/  1  l_  1     III  IS 

Center  for  Regulatory  Services,  Inc. 

201 1-4550 

£_  V/  1    1       I  \J  ^J\J 

2012-8692 

L—\J    1  t—    \J\J\J  L— 

12/06/2012 

1  t—l  \J\Jl  L—\J\S— 

ORA/ 

Rrittanv  Frppman 

is)  1  1  LIC4.I  ly    1    1  vZ vZ  1  1  IUI  1 

AMERIDOSE  -  COMPLAINTS  REFERENCED  IN  483 

i  \  i  v  1 1_  i  ii  \s  Vw/  Vw/ 1          v/  Vw/ 1  v  1 1    I  i  \  nil  Vw/  i  1 1_  i    i_  i  1 1_  i  vi  v/  i  i — /   1 1  vi  ^ryij 

01/07/2013 

ORA/ 

WSMV  TV 

2012-8693 

12/06/2012 
01/07/2013 

FDA/OC/OES/DFOI/ 

KRISTI  0  SMEDLEY  PHD 

Center  for  Regulatory  Services,  Inc. 

2011-8937 

2012-8694 

12/06/2012 
01/07/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

CAERS  151606,  151607,  151881,  ETC 

2012-8695 

12/06/2012 
01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Willard  Bond  Wells  III 
PRIVATE  CITIZEN 

AMARIN  VASCEPA  -  RESPONSE  LETTER  CIRCULATED  BY 
CDER  EXCLUSIVITY  BOARD 

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Reed  Date  / 
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Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  i  \l  V_/ 1 V  1 1     II  \J  Is  1  1  1/  W  III    /  IS  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8696 

L—\J    1  t—  \J\JsJ\J 

12/06/2012 

1  t—l  \J  \JI  t—  \J  1  t— 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  Vw/  1  v  1  1      It  \-S  IS  1  11   If  \S  \S  1—  1  1/  IS  1    \S  11 

Rphprra  Shplhurnp 
Ellipse  Technologies,  Inc. 

K031219 

1  \\J  Kj    1  L_    1  \J 

2012-8697 

12/06/2012 

1  t—l  \J\JI  S—\J\t— 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  \S  1  v  1  1      II  \J  IS  1  11   If  \S \J  l_  1  1/  IS  1    \S  II 

Rphpppa  Shplburnp 
Ellipse  Technologies,  Inc. 

K0 10322 

1  V  V/  1  v/  Vw»  £_  £— 

2012-8698 

L—\J    1  t—  \J\J\J\J 

12/06/2012 

1  t—l  \J  \JI  t—\J\t— 

01/07/2013 

ORA/ 
ORA/ 

Brittany  Frppman 

1 — '  1  1  L  LCI  1  IV    1    1  V/ V/  1  1  IUI  1 

WSMV  TV 

NECC  AMERIDOSE  -  PHOTOS  VIDEOS  TAKING  DURING 

1  *J  1  Vw/  Vw/  ,    /  VI V  1  1— —  1  II  L/  Vw/  Vw/  1             1     1   1  \S  1  V-/  V_J  ,     V  1  IS  1  \S  v_/     1  / \  1  \  1  1  *J  Vwl    !_/  V*/  1  1 1  1  VI  V—i 

INSPECTIONS 

2012-8699 

12/06/2012 

1  t—l  \J\JI  S—\J\t— 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  \w/  1  v  1  1      11  \  '  IS  1  11   If  \S  \  '  l_  1  1/  IS  1    Vw/  1/ 

John  Oodv 
Medi  USA,  LP 

K941926 

2012-8700 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Virginia  Anello 
DOUGLAS  &  LONDON 

K823115 

2012-8701 

12/06/2012 

1  t—l  \J\JI  S—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \s  III    /  IS  1  L/  1  / 

Rrittanv  Frppman 

IS  1  1  Lldl  ly    1    1  UUI  1  IUI  1 

ZZZQUIL  -  AERS  (01/01/2010  -  12/05/20121 

£    *    *   v  l|  V/  1  1            / \ l_  1  I V/    l  U  \  I  \J  \  1  s—\J  1  v/          1  L—l  \J  -SI  i—\J  1  L—  J 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WSMV  TV 

2012-8702 

12/06/2012 

1  t—l  \J\JI  S—\J\t— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  l_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  SOLKINEN 

I  \  1  *l  1  *l  l_   \S  Vw/  1  1  VII  N  1— —  1  "J 

ORION  PHARMA 

DR  KIMMO  INGRAM  ORION  PHARMA  R&D  ESPOO 

IS  1  l    1  V  1  1  v  1  1  v  1  V- /    1  1  N  Vwi  1  1 1  \  \  VI,    Vw/  III  \w/  INI     II  /  V 1  1 1 V 1  /  \    1   \  l_X.  1  /  ,         Vw/  1     Vw/  V_/  , 

FINLAND  -  ALPRAZOLAM  TABS  ANDA  200-818  EIR  10/18- 
22/10 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  1— /  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8703 

12/06/2012 
01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

FERNANDO  SABA 
Laboratories  SL  S.A. 

K103816 

2012-8704 

12/06/2012 

1  t—l  \J \JI  t—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  IS  1  J  /  1  / 

1  aurpn  Tornptt3 

NDA  18401  -  SBA 

1  *J  \S  1  \     1  V/     V/  1         Vw/ 1_/  /  V 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Endo  Pharmaceuticals  Inc. 

2012-8705 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

John  Crewdson 

ZOSTAVAX  -  CORR,  MEMOS,  EMAIL  ETC  RE  RISK 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

\S  V  1— —  1  1  \S  1  V_H  1   1  1 

ASSESSMENT 

2012-8706 

12/06/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  SOLKINEN 

DR  F  H  VAN  HEUVELN,  XENDO  DRUG  DEVELOPMENT  BV, 
BIOTECH  CENTER,  GRONINGEN,  NETHERLANDS  - 

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Subject 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ORION  PHARMA 

ALPRAZOLAM  TABS  AN  DA  200-818  EIR  10/4-8/10 

2012-8707 

L_  \J    1   t—     \J  1    \J  i 

12/06/2012 

1  t—l  \J\Jl  t—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1          1  /  1      \l    Vw/  |  V  1   1             If     \  '    L/    1            1       1/    \w/  III         /     1  '    1   IS   1  / 

Tom  Rurtnn 

COMPOUNDING  PHARMACIES  -  AERS 

Vw*  Vw/  1 V 1  1     Vw/  Vw^  1  V|  I — /  |  |  VI  Vwl    1     1   li  \  1  1 1 V  1 J  \  \—S  1  1  V/        /  V  l_  1  I 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WALL  STREET  JOURNAL 

2012-8708 

12/06/2012 

1  t—l  \J\Jl  L—\J\C— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  SOLKINEN 
ORION  PHARMA 

STEPHAN  M  JAKOB  MD  INSELPITAL  BERN  SWITZERLAND 

V/  1  1  1     1   1  /  \  1  M    1  V 1  V/  /  \  1  V  Vw/         1  V 1  L*S  ,    1  1  M  VtJ  l_  1  1     II  1  \  \  ,  I— J  1  1  1 1  VI  .    Vw/  V  V  1  1  ^  1  1  I  l_V  \  1  V|  I — / 

-  RECEDEX  (DEXMEDETOMIDINE  HCL  INJ)  NDA  21-038  EIR 
3/26-29/12 

2012-8709 

12/06/2012 

1  t—l  \J\Ji  t—\J\(— 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  l_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ANNE  SOLKINEN 

i  \  i  *i  i  *i  i__  Vw/  Vw/ 1  1  vii  vi  i— _  i  vi 

ORION  PHARMA 

ANTHONY  DUGARD  MD  HOSPTIAL  DUPUYTREN  LIMOGES 

/  \  1  *J   1   1    1  Vw/  1  VI   1  1 — /  V/  V—i  /  \  1  1  L/    1  v  1  L/  j    1   1  Vw/  V/  1      1  1  /  V 1       L/  V/  1     V/   1     III  1  IN.    L_  1  1  v  1  V/        1  V/  . 

FRANCE  -  RECEDEX  (DEXMEDETOMIDINE  HC;  INJ)  NDA  21- 
038  EIR  3/19-23/12 

2012-8710 

12/07/2012 
01/08/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

JOHNATHAN  RICKMAN 

i — I- V  A    h  1  i — ia/o 

FDA  NEWS 

KUTOL  PRODUCTS  CO,  SHARONVILLE,  OH;  ACCUPAK 
MIDWEST  INC,  CINCINNATI,  OH;  MEDICAL  QUANT  USA  INC, 
SOLON,  OH  -483S  10/1-31/12 

2012-8711 

12/07/2012 
01/08/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

GRESCO  PRODUCTS  INC,  STAFFORD,  TX;  ADVANCED 
AESTHETIC  CONCEPTS  LP  (PROFITSOLUTIONS  MD),  FT 
WORTH,  TX  -  483S  10/1-31/12 

2012-8712 

12/07/2012 
01/08/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

CODY  LABORATORIES  INC,  CODY,  WY;  CERAPEDICS  INC, 
WESTMINSTER,  CO  -  483S  10/1-31/12 

2012-8713 

12/07/2012 
01/08/2013 

FDA/OGROP/ORA/CE-FO/DET- 
DO/DET-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

DANMAR  PRODUCTS  INC,  ANN  ARBOR,  Ml;  KREMERS 
URBAN  PHARMACEUTICALS  INC,  SEYMOUR,  IN;  ENZYME 
SOLUTIONS  INC,  GARRETT,  IN  -  483S  10/1-31/12 

2012-8714 

12/07/2012 
01/08/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

THEOCHEM  LABORATORIES  INC,  TAMPA,  FL;  SRI 
SURGICAL,  TAMPA,  FL;  ASO  LLC,  SARASOTA,  FL,  ETC  - 
483S  10-1-31/12 

2012-8715 

L—  \J    1   t—     \J  1      1  \J 

12/07/2012 

1  t—l  \J  1  1  t—\J  \  C— 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JOHNATHAN  RICKMAN 

\j  v»/ 1  1 1  vi  I  \  i  i  1 1  \  i  vi  iii  \j  i  \  i  v  1/*  i  X 

FDA  NEWS 

EXCELLA  GMBH  FEUCHT  GERMANY' SANDOZ  GMBH 

1  /  V  V/  1  1  1  1  \   Vw4  1 V 1  1  J  1   1  .    1    l_  V/  V/  1    1  1   ,    Vwi  1— —  1  1 1  VI/  11  *J    1    n    V/ 1  \  1  V|  l_/  Vw/  L       V_-1  1  V 1  I  l  1   1  . 

KUNDL,  AUSTRIA;  UMAN  PHARMA  INC,  CANDIAC,  CANADA, 
ETC-483S  10/1-31/12 

2012-8716 

12/07/2012 
01/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

MALEM  MEDICAL,  NOTTINGHAM,  UK;  OY  A  J  AT  LTD,  ESPOO, 
FINLAND;  CREASPINE  SAS,  PESSAC,  FRANCE,  ETC  -  483S 
10/1-31/12 

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Subject 

2012-8717 

12/07/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

JOHNATHAN  RICKMAN 

HOSPIRAINC,  MCPHERSON,  KS  -  483S  10/1-31/12 

01/08/2013 

DO/KAN-CB/ 

FDA  NEWS 

2012-8718 

12/07/2012 

FDA/OGROP/ORA/PA-FO/LOS- 

JOHNATHAN  RICKMAN 

NEOMPS  INC,  SAN  DIEGO,  CA;  DAKO  NORTH  AMERICA  INC, 

01/08/2013 

DO/LOS-CB/ 

FDA  NEWS 

CARPINTERIA,  CA;  INNOVATIVE  MED  INC,  IRVINE,  CA,  ETC  - 
483S  10/1-31/12 

2012-8719 

12/07/2012 

FDA/OGROP/ORA/CE-FO/MIN- 

JOHNATHAN  RICKMAN 

CONKLIN  COMPANY  INC,  SHAKOPEE,  MN;  ZYGA 

01/08/2013 

DO/MIN-CB/ 

FDA  NEWS 

TECHNOLOGY  INC,  MINNEAPOLIS,  MN;  DANE 

TECHNOLOGIES,  BROOKLYN  PARK,  MN,  ETC  -  483S  10-1- 
31/12 

2012-8720 

12/07/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 

JOHNATHAN  RICKMAN 

ORTHO  CLINICAL  DIAGNOSTICS  INC,  RARITAN,  NJ;  PACON 

01/08/2013 

DO/NWJ-CB/ 

FDA  NEWS 

MFG  CORP,  SOMERSET,  NJ  -  483S  10/1-31/12 

2012-8721 

12/07/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

JOHNATHAN  RICKMAN 

RADIUS  MEDICAL  LLC,  HUDSON,  MA;  IKONISYS  INC,  NEW 

01/08/2013 

DO/NWE-CB/ 

FDA  NEWS 

HAVEN,  CT;  KEYSTONE  DENTAL  INC,  BURLINGTON,  MA, 
FTP.  -  48'3C;  1  (1/1 -T1  /1  ? 

2012-8722 

12/07/2012 

FDA/OGROP/ORA/SE-FO/NOL- 

JOHNATHAN  RICKMAN 

HOWARD  INSTRUMENTS  INC,  TUSCALOOSA,  AL  -  483S 

01/08/2013 

DO/NOL-CB/ 

FDA  NEWS 

10/1-31/12 

2012-8723 

12/07/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

JOHNATHAN  RICKMAN 

CHEMBIO  DIAGNOSTIC  SYSTEM  INC,  MEDFORD,  NY; 

01/08/2013 

DO/NYK-DCB/ 

FDA  NEWS 

PROPPER  MFG  CO  INC,  LONG  ISLAND  CITY,  NY;  BUSSE 

HOSPITAL  DISPOSABLES,  HAUPPAUGE,  NY,  ETC  -  483S 
10/1-31/12 

1  \JI     1       O    1  /     1  L. 

2012-8724 

12/07/2012 

FDA/OGROP/ORA/CE-FO/PHI- 

JOHNATHAN  RICKMAN 

BEST  MEDICAL  INTERNATIONAL  INC  (BEST  NOMOS), 

01/08/2013 

DO/PHI-CB/ 

FDA  NEWS 

PITTSBURGH,  PA  -  483S  10/1-31/12 

2012-8725 

12/07/2012 

FDA/OGROP/ORA/PA-FO/SAN- 

JOHNATHAN  RICKMAN 

AESTHETIC  AND  RECONSTRUCTIVE  TECHNOLOGIES  INC, 

01/08/2013 

DO/SAN-CB/ 

FDA  NEWS 

RENO,  NV;  TERARECON  INC,  FOSTER  CITY,  CA;  SCITON 
INC,  PALO  ALTO,  CA  -  483S  10/1-31/12 

2012-8726 

12/07/2012 

FDA/OF/CFSAN/OCD/EOS/ 

SEAN  HIGGINS,  Esq 

MONSTER  REHAB  GREEN  TEA  &  ENERGY;  DIETARY 

01/08/2013 

ANDREWS  THORNTON 

SUPPLENMENTS  CONTAINING  EPIGALLOCATECHIN  3 
GALLATE  -  AER 

2012-8727 

12/07/2012 

FDA/OM  PT/CD  E  R/OR  P/D I  DP/ 

I    I  '  I  \i  \w/ 1  v  1 1     ll  \j  1— •*  I  I  1/  v_y  in   /  L-/  i  L>  i  / 

PATRICK  E  LLJPINETTI 

1    1  \  1  1  1 1  W  I  \   1  .    1  V.J  1     1 1  M  1       1  II 

BULK  INGREDIENTS  FOR  HUMAN  RX  COMPOUNDING  - 

1  >  kJ  \  l\    1  1  *J  U  1  11  L~/  1 1  IN  1  VJ    1    Vw/  1  1    1   lUIVInl  M    1  l/\    WWIvll     V/UI  >IL/IIN\J 

\J  1  f\J\J/  <—\J  1  o 

FnA/OMPT/nnFR/DRP/nmp/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    111  O  1    LJ  f  \  1  f\  \—)f\  WW 

LBLG 

2012-8728 

12/07/2012 

FDA/OGROP/ORA/PA-FO/SEA- 

JOHNATHAN  RICKMAN 

CUSTOM  OCULAR  PROSTHETICS  INC,  SEATTLE,  WA; 

01/08/2013 

DO/SEA-CB/ 

FDA  NEWS 

ELIXIR  RESEARCH  LLC,  VASHON,  WA;  DE  HOKANSON  INC, 
BELLEVUE,  WA-483  10/12 

2012-8729 

12/07/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

JOHNATHAN  RICKMAN 

ABC  COMPOUNDING  CO  INC,  MORROW,  GA;  CAROLINA 

01/08/2013 

DO/ATL-CB/ 

FDA  NEWS 

MEDICAL  PRODUCTS  CO,  FARMVILLE,  NC;  CRYOLIFE  INC, 
KENNESAW,  GA  -  483  10/12 

2012-8730 

12/07/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 

JOHNATHAN  RICKMAN 

AG  ESSENCE  INC,  RICHMOND,  VA;  PHARMACEUTICALS 

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DO/BLT-CB/ 

FDANEWS 

INT'L  INC,  HUNT  VALLEY,  MD  -  483  10/12 

2012-8731 

12/07/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

JOHNATHAN  RICKMAN 

AKORN  INC,  DECATUR,  IL;  RAANI  CORP,  BEDFORD  PARK, 

01/08/2013 

DO/CHI-CB/ 

FDA  NEWS 

IL;  HOME  ACCESS  HEALTH  CORP,  HOFFMAN  ESTATES,  IL  - 

48^  10/1? 

too  I  \JI  1  c 

2012-8732 

12/07/2012 

1  C—l  \J  1  1  t—\J  1  £_ 

FDA/OMPT/CTP/OD/ 

DESMOND  JENSON 

L*S  1—  \—J  1  v  1  Vw/  1  *J  L/   1/  l_  1  >l  v_/  V/  1  N 

SMOKEMATE  -  ECIGARETTES  INVESTIGATION 

'  >  1 V  1  V_/  |  \  ■  |  V 1 1  1  1  1             1  \J  1  V  A  t  \  1  1 1       1    1  1  v  1    |  |  M  V  1  i  1  1  1  \^AI  V  1  1  V  J  |  M 

01/08/2013 

Tnharro  Control  1  pnal  Oon^ortium 

1  V/k/aWV>V/    V/  V/  1  III  V/  1  I — Cll    V-/  V/ 1  IOV/  1  LI  LI  1  1  1 

Of~H  O  0700 

12/07/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

PATRICIO  T.D.  BARRERA 

l/DAH^CD  1    ADO  IMP           f~\  I-)  I-)    I  hi  A  D)  K 1 1  M/~*  1  TD          ft  O  CT  Dl    A  A^* 

KKAMtH  LABb  INO  -  OOHK,  WAKNINfj  L  1  K,  L-Abt  rLA  06- 

01/08/2013 

DO/FLA-CB/ 

BARRERA  &  ASSOCIATES 

05 

2012-8734 

12/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1 V  1  1      1  /  \m/  L-/  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

RAVI  DESHPANDE 

1  1 1  \  V  1    J  /  l_  V/  1   1  1    /  \  1  *l  \—J  1  

TARO  PHARMACEUTICALS  -  TERCONAZOLE  VAGINAL 

1  1  \  1  1  Vw/    1     1   1 1  \  1  1 1  VI/  V  Vw/  1  V/  1  1  V/  /  \  L_  O          1  1  1  1  V/  Vw/  1  *J  /  V  £  Vw/ 1_  1         V  f\  V_/  1  1  HI  V 1— 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ACINO  PRODUCTS  LLC 

SUPPOSITORY  ANDA  077553,  PROMETHAZINE 

HYDROCHLORIDE  SUPPOSITORY  ANDA  040603, 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

PPPlMCTI-l UIVRPPtPUl  PiPIRP  Ql  IPPflQITHRV  AMRA 

r riVJivic  1  riMZ-HMC  n Y UnwL/nLL^riiiJc  oUrrUol  1  vjrii  minum 

FDA/OMPT/CDER/ORP/DIDP/ 

040603  -  SBA 

2012-873'S 

12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/ 1  \i  \w/ 1 V  1 1      1  /  V/  L/  1  11   l/\*r\Jl  1  l'l_/l    Vw/  1  / 

JAY  WINCKLER 

w !  \  1      V  ¥  1 1  M  \J  1  \l_l  1  I 

LANX  SPINAL  FIXATION  SYS  K09328'i 

1  1  \  1  N/\   V  '  1     1 1  N  l\  \       1     l/\n  1  1  Vw/ 1  V    \  )  1  \  )    1  \\J\J\JC-\J\J 

01/08/2013 

WINCKLER  &  HARVEY  LLP 

2012-8736 

12/07/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1    J  /  /  V/  Vw/  1    /  Vw/  1    ^w*  /  V 1  >!/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

ERIKA  DUTHELY 

l_  1    III  \l    \     }  /  Vw^    i    I     1  l_  1   i 

BRAZILIAN  BLOWOUT  -  CMPLNTS  AER  SINCE  1/1 1 

l— J  1   It  \ L  1  1  1 1  \  1  N    l—J  I—  Vw/  V  V  Vw/  Yw^  1          Vw/ 1  v  1  1     1  1  v  1  \—>  ,    /  \  1  1  I   v/  1  1  M  Vw/  l_     1  /    1  1 

01/08/2013 

OC/COS/OES/ 

ENVIRONMENTAL  WORKING 

OC/COS/OES/ 

GROUP 

OC/COS/OL/ 

2012-8737 

12/07/2012 

FDA/OF/CFSAN/OCD/EOS/ 

CHRISTOPHER  HENDEL 

RELAXATION  -  AER,  1/04  TO  PRESENT 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

CONSUMER  REPORTS 

V/  \  '  1  N  *w/  LJ  1  V 1  1  1  1    1  1 1_  1     Vw/  1  1  1  V/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  ( — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8738 

12/07/2012 

1  t—l  \J  1  1  t—\J  1  t— 

FDA/OGROP/ORA/CE-FO/NWJ- 

1    1  /  /  V/  Vw/  \J  1  1  V_/  1    /  Vw/  1  1/  V/  V/  l__    1    Vw//  M  V  W  U 

VICTORIA  SCOTT 

V  IV/  1  Vw/  1  1 1  / \  V/  Vw/  Vw/  1  1 

HEMISPHERX  BIOPHARMA  INC  -  INSP  1 1/27-28/12 

1   1  1  1 V  1  1  V/  1     1   1  1  1   1  /  V    1  >  1  Vw/  1     1   1/  VI  1 1  v  1  /  V    1  1  M  V/        1 1  i|  v»/  1        ll/^i     L—  \JI    1  L_ 

01/08/2013 

DO/NWJ-CB/ 

HEMISPHERX  BIOPHARMA 

i  1 1— _  i  v  1 1  ^h/ 1    i  1 1— _  i  i  /  v  i— J  i  v/ 1    i  1 1  \  i  1 1  v  1 1  \ 

2012-8739 

12/07/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

MICHAEL  LOUIK 

DEPUY  ORTHOPAEDICS  INC  -  3  PEG  MOD  ROT  PATELLA 

01/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

ROSEN  LOUIK  ET  AL 

CEMENTED 

2012-8740 

12/07/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

IVANO  FRANKOVSK  REGIONAL  FORENSIC  MEDICAL 

01/08/2013 

W  1  /  UU/     V/  1  o 

FDA/OMPT/CDER/ORP/DIDP/ 

1    I  '  / V/  Vw/ 1 V  1  1      1  /  V/  L/  1  1  1/  V/  III    /  1— '  1  1— '  1  / 

WILSON  KATE 

V  V  1 1  Vw^  Vw/  In.    1  V/  V  1  1  

BUREAU,  UKRAINE  FEI  3007016079 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 

ALFB/ 

2012-8741 

12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 

UNITED  STATES  SURGICAL  CORP  -  LETTER  FROM  FDA  RE 

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01/09/2013 

FOI  Services,  Inc. 

RECLASSIFICATION  OF  NONABSORBABLE  PET  SUTURES 

(07/05/1990) 

2012-8742 

12/10/2012 
01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— '  1    \i  \w/  1  V  1  1         It   \-S  L/  1    11     1/  \S  \m/  1— —  1    1/  1 — /  1      Vw/  1/ 

FDA/OC/OES/DDM/ 

Rqphpl  Johnson 

1  IClvl  1  v/ 1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

ADVANCED  BIORESEARCH  ASSOCIATES  -  PETITION  FOR 

/  V  L/  v  /  VI  *J  Vw/  l_  1 — '  I— J  1  Vw/  1  1 1_  U  l_  I  \  \  1  Vw/  1   1    /  V  Vw/  Vw/  Vw/  V/  1  /  \  1  1  V/        1     1       1  1  1  1  Vw/  In    1    v/  1  I 

RECLASSIFICATION  RE  SURGICAL  SUTURES 

2012-8743 

12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

KYOCERA  Medical  Cnrnoration 

1  V  1  Vw/  V/  1  1  I V  \   1 V 1 v/  1 WC1I    V-/  V/  1  k/ V/  1  d  L 1 V/  1  1 

K050327 

01/09/2013 

FDA/OC/OES/DFOI/ 

KYOCERA  Medical  Corporation 

2012-8744 

C—  \J  1  C—    \J  1     I  I 

12/10/2012 

1  C-l   1  \JI  C-\J  1  C 

01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— '  / V/  \w/ 1 V  1 1      1  /  V/  L/  1  11   l,V_/V_/[  |  1/  I  /  I  v_/|/ 

Rphpppa  Shplhiirnp 

1  1 C UCUbU  Ul  ICIUUI  1  IC 

Ellipse  Technologies  Inc 

K023941 

1  V  W  £_v/  v/  i  1 

2012-8745 

t_v/  1  £_   v/  /  ^  ' 

12/10/2012 
01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— '  / V/  Vw/ 1 V  1 1      1  /  V/  1  '  1  11   l/V_/V/l  1  U  L/l    VwX  1  / 

JILL  GOLDSTEIN 

Ij  1 1  1             \7  1  L/  V/  1  1  1  1  >■ 

GOLDSTEIN,  JILL  S 

K1 22350 

1  v  1  LLUJU 

2012-8746 

12/10/2012 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 

Charlotte  Dannenfelser 

BD  DIAGNOSTIC  SYSTEMS,  SPARKS,  MD  -  EIR  (04/23/10) 

01/09/2013 

DO/BLT-CB/ 

BD  DIAGNOSTIC  SYSTEMS 

2012-8747 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  1 — /  I  J  /  I  / 

INDIVIDUAL  RECS 

1  1  VI  L/  1  V  1  1  '  Vw/  /  \  L_    1  1  L_  Vw/  Vw/ 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  \—/  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-8748 

12/10/2012 
01/09/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Rachel  Johnson 
FOI  Services,  Inc. 

FCN  647 

/*v/*v  -<  c"\ 

2012-8749 

12/10/2012 
01/09/2013 

i —  i- \  a  //~v/~ » //~\  i —  o  /r™\  i — /""\  i  / 

FDA/OC/OES/DFOI/ 

Maryann  Ivie 

COSGRAVE  VERGEER  KESTER 
LLP 

FOIA  REQUESTS  RE  INVACARE  (02/01/2008  -  1 1/30/2012) 

2012-8750 

12/10/2012 

FDA/OGROP/ORA/CE-FO/CIN- 

Eric  Gandhi 

INVACARE  CORP,  OHIO  -  483  (06/01/201 1  -  08/31/201 1) 

01/09/2013 

DO/CIN-CB/ 

Robeco  Investment  Mgmt. 

2012-8751 

12/10/2012 

1  t—l    1  \JI  L—\J\t— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

Rohprt  Willima^ 

1   I  V/  KJ      1  L    VV  Mill  1  1  dO 

VYVANSE  -  AERS 

V    1    V  /  VI  M  V/  1            1  \  l_  1  I V/ 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  1— /  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Shire  Pharmacueticals 

2012-8752 

12/10/2012 

1  t—l    1  \JI  L—\J\t— 

01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  \J  L/  1  11   1/  Vw/  V/  l__  1  1/  1  /  1    Vw/  1/ 

Rphpppa  fihplhnrnp 

1  lOUUUUU  VJ  1  I^IUUI  1  1  \j 

Ellipse  Technologies,  Inc. 

K092138 

2012-8753 

12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  !_/  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

Rarhpl  .Inhn^nn 

1  IGIV^I  Ivl   IwfV/l  II  IOUI  1 

K0601 19 

1  \\J\J\J  1  1  \J 

01/09/2013 

FDA/OC/OES/DFOI/ 

FOI  Services  Inc. 

2012-8754 

12/10/2012 
01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rebecca  Shelburne 
Ellipse  Technologies,  Inc. 

K011354 

2012-8755 

12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Joakim  Arwidson 

K093982 

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01/09/2013 

Hermes  Medical  Solutions 

2012-8756 

12/10/2012 
01/09/2013 

OM/OMP/DODIW 
FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

GENERAL  AND  PLASTIC  SURGERY  DEVICES  PANEL 
MEETING  -  SUPPORTING  MATERIALS  (10/20/1988) 

2012-8757 

12/10/2012 

ORA/ 

AnnMarie  Beattie 

ENTRY  G76-01 29576-7  -  LAB  RESULTS 

01/09/2013 

ORA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Harmonized  Customs  Brokers,  Inc 

2012-8758 

12/10/2012 
01/09/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

MIGUEL  WENCASLAO  TREGNAGHI,  ARGENTINA  -  EIR,  483, 
WARNING  LETTER  ETC 

V  V  1  V 1  1 1  VI  1  1  V|  VJ    1  l__  I     I  l__  I  1 .    I__  ]  VJ 

2012-8759 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOGS  11/12-16/12 

2012-8760 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  11/19-23/12 

2012-8761 

12/10/2012 

1     /  1  V//     V/  1  i— 

01/09/2013 

FDA/OC/OES/DFOI/ 

1  1— fi\l  v./  Vj/  VJI — O/  1— /  1    VJ  1/ 

LISA  TARRISON-SCHRAMP 

1  1  \J  J  \     1  /  \  [  11  11  Vj  VJM  VI    Vj  VJ  1   1  1  lf\l  V  1  1 

CanReg,  Inc. 

FOI  DAILY  LOG  11/12-16/22 

1     VJ  1     U 1   \  \  1        1      \  VJ  VJ      1     1  /    1  £_      1  \JI  L—  L— 

2012-8762 

L—  VJ  1  L    VJ  /  UL 

12/10/2012 

1  £-/   1  V//  £_U  1 

01/09/2013 

FDA/OC/OES/DFOI/ 

1  1— ' /V/  VjVJ/  VJ  1 — O/  1— '  1     VJ  1/ 

LISA  TARRISON-SCHRAMP 

i  i  vj  i  \   \  1  \  i  ii  ii  vj \j\  vi  v  )  vj  i  1 1  ir\i  VI  1 

CanReg,  Inc. 

FOI  DAILY  LOG  11/1 9-2^/1 2 

1    VJ  1    U 1  \  \  1       1     1  VJ  VJ     1    1  /   1  J    C—\Ji    \  t_ 

2012-8763 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

i    i— vj  Vw//  vj 1 —  vj/  u  i  Vw/ 1/ 

BARBARA  JONES 

U I  \  1  1 1  >  1  \  \  \  I  \  VJ  VJ  1  *J  1  ^J 

DOMINION  GROUP  INC 

FOI  DAILY  LOG  11/12-16/12 

1    VJ  1    U  /  VI  1       1     L_  VJ  VJ     1    1  /   1  £_     IV//    1  L— 

2012-8764 

12/10/2012 

1  t—l    1  \JI  L—\J\S— 

01/09/2013 

FDA/OC/OES/DFOI/ 

1    1— Vw/  Vw//  Vw/  1 —  VJ/  U  1    Vw/  1/ 

BARBARA  JONES 

U I  \  \  l  U I  \  \  \  I  \  \J  VJ  1  M  1  VJ 

DOMINION  GROUP  INC 

FOI  DALILY  LOG  11/19/23/12 

1    VJ  1    U /  V  l_  1  1       1     L_  VJ  VJ     1    1  /    I  \JI  L—\Jl    \  L— 

2012-8765 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

1    U*V  VJ  VJ/  VJ  1 —  VJ/  U  1    VJ  1/ 

GLADYS  B  TONKINS 

vj  i  i  \  u  i  vj  u    i  vj  i  vi  i  \  1 1  *j  vj 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  11/12-16/12 

1    VJ  1    U  /  VI  1       1     L_  VJ  VJ     1    1  /   1  £_     IV//    1  L— 

2012-8766 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

GLADYS  B  TONKINS 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  11/19-12/12 

2012-8767 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

DEBRAL  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  11/19/23/12 

2012-8768 

12/10/2012 
01/09/2013 

FDA/OC/OES/DFOI/ 

DEBI  L  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  11/12-16/12 

2012-8769 

12/10/2012 
01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  A  KNOLL 
COHEN  &  MALAD  LLP 

FRESSENIUS  MEDICAL  CARE  NORTH  AMERICA  - 
NATURALYTE  LIQUID  ACID  CONCENTRATE  &  NATURALYTE 

Page  158  of  895 


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Total  Records:  9990 


Control  # 


Reed  Date  / 
Due  Date 


Action  Office 


Signature/  Requester 


Subject 


GRANUFLO  (POWDER)  ACID  CONCENTRATE  K30497, 
K023985,  K911459,  ETC  (CERTIFIED)  


2012-8770 


12/10/2012 
01/09/2013 


FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 


JONATHAN  A  KNOLL 
COHEN  &  MALAD  LLP 


FRESSENIUS  MEDICAL  CARE  NORTH  AMERICA  - 
NATURALYTE  LIQUID  ACID  CONCENTRATE  &  NATURALYTE 
GRANUFLO  (POWDER)  ACID  CONCENTRATE  MEMOS, 
CORR  RECALL,  ETC 


2012-8771        12/10/2012  FDA/OMPT/CDER/ORP/DIDP/ 
01/09/2013  FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


JOHN  CREWDSON 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 


XIGRIS  (DROTRECOGIN  ALFA);  MERIDA  (SIBUTRAMINE); 
REDUCITIL  (SIBUTRAMINE),  ETC  -  CLNCL  INSP  SUMMARIES 


2012-8772 


2012-8773 


2012-8774 


2012-8775 


2012-8776 


2012-8777 


12/10/2012 
01/09/2013 

12/10/2012 
01/09/2013 


12/10/2012 
01/09/2013 


12/10/2012 
01/09/2013 


12/10/2012 
01/09/2013 

12/10/2012 
01/09/2013 


FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

F  D  A/OG  ROP/O  R  A/C  E-  FO/B  LT- 
DO/BLT-CB/ 


FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 


JOHN  CREWDSON 

PROJECT  ON  GOVERNMENT 
OVERSIGHT  

MICHAEL  R  COHEN 

INSTITUTE  FOR  SAFE 
MEDICATION  PRACTICES 


CANDICE  DURENCE 

OPTIMER  PHARMACEUTICALS 
INC 


MERCK  -  ZOSTAVAX  VACCINE  OSI  CLNCL  INSP 
SUMMARIES 


MEDWATCH  RPTS  CODES  AS  MEDICATION  ERRORS  1 1/1- 
30/12 


DIFICID  (FIDAXOMICIN)  NDA  201-699  -  ISR  8652998, 
8691126 


PROLIA  -  AERS 


RINGELHEIM,  A 


LORI  KERSEY 
CHARLESTON  GAZETTE 

JANPAUL  PORTAL 
FERRAROLAW  FIRM 


YEAGER  AIRPORT,  CHARLESTON,  WV;  TRI-STATE 
AIRPORT,  HUNTINGTON,  WV;  NORTH  CENTAL  WEST 
VIRGINA  AIRPORT,  CLARKSBURG,  WV,  ETC  -  EIRS  201 1 , 
2012 

INDIVIDUAL  RECS 


Page  159  of  895 


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Total  Records:  9990 


 1  1  If 

Control  # 

Reed  Date  / 

Action  Office 

Signature/  Requester 

Subject 

Due  Date 

DO/SAN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L-/  / V/  Vw/ 1 V  1 1      1  /  v/  l_/  1  11   l,V_/V_/[  |  1/  I  /  I  V_/|/ 

?D1  2-8778 

12/10/201? 

1  C-l  \  \J1  C-\J  1  C 

IOHN-MARK  7INI 

ARL  LBIOPHARMA  INC  (ANALYTICAL  RESEARCH  LABS! 

i\  i  ii     i  i  j  i  v/ 1   i  1 1\  i  1 1  v  i  /  \  1 1  m  v/  ini  ini     i  i  i  v_/ 1 \  \     i  ii  oi  /\  i  ivi  i  i  / v  i  >  v  j  \ . 

01/09/2013 

DO/DAL-CB/ 

GIDEON  COOPER  &  ESSARY 

OKAHOMA  CITY  OK  -  483S 

Vw/ 1  XV  V 1   1  Vw /  1 V 1 1  \   V/  II     1  -  Vw /  1  \        *T  KJ \J  V/ 

2012-8779 

12/10/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

STACI  M  TROLIAN 

DR  MARK  ALAN  MIGHELL-  CO  RESP  TO  WARNING  LTR 

01/09/2013 

DO/FLA-CB/ 

BIOMET 

7/6/05 

FDA/OMPT/CDRH/OCER/DFOI/ 

2012-8780 

12/10/2012 

FDA/OGROP/ORA/NE-FO/NWE- 

JONATHAN  A  KNOLL 

FRESSNIUS  MEDICAL  CARE  NORTH  AMERICA  - 

01/09/2013 

DO/NWE-CB/ 

COHEN  &  MALAD  LLP 

NATURALYTE  LIQUID  ACID  CONCENTRATE  &  NATURALYTE 

FDA/OGROP/ORA/PA-FO/SAN- 

GRANUFLO  (POWDER)  ACID  CONCENTRATE  -  EIRS,  483b 

DO/SAN-CB/ 

2006  (CERTIFIED) 

FDA/OGROP/ORA/SW-FO/DEN- 

DO/DEN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1— /  1  i  /  1  / 

FDA/nMPT/nnFR/nRP/nmp/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  V/  l_/  1  1  1/  W  III    /  L/  1  ]  /  1  / 

FnA/nMPT/nnRH/nnFR/DFDi/ 

n  \—st\/  v_/ivi  n  i  /  \j  i— '  rii  1/  v_y  v_/ 1  i  v  lj  i  v_y  i/ 

2012-8781 

12/10/2012 

1  t—l    1  V//  t-W  1  C— 

FDA/OMPT/CTP/OD/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  1  1    /  Vw/  1  /  / 

DESMOND  JENSON 

L- /  1—  K-f  1  v  1  Vw/  1  M  1  J   \J  l__  1  M  \_/  Vw /  1  N 

METRO  SUPER  SAVER  -  SMOKELESS  TOBACCO  PROD 

i  v  1 1      i  i  i  Vw/  v/  v/  i    i  i  i  v/  /  v  v  i— _  i  i      v/ 1  v  i  Vw/ 1  \  i_  i  i  i  Vw/  unv/v/v/  i    i  i  v^/ 1_/  , 

01/09/2013 

Tohppfo  f^nntrnl  1  pnal  OnnQnrtinm 

1  LJ UCl^L-LJ  V/UI  1 11  KJl   LCL) dl   W LJ 1  IOUI  LI  U  1  1  1 

MARBORO  LIGHTS  INVESTIGATION  &  FOLLOW-UP  ACTION 

201  2-878? 

1     /  1  \JI  C\J  \  (— 

FnA/OfiROP/ORA/PA-FO/^AN- 

KriQtan  PhillinQ 

I\l  loLCil  1  1    1  IIIIILJo 

MFDIVATIDN  "^AN  FRANHI^nD  CA  -  dRI  C0R/P7/1  9\ 

IV 1 1  I— J 1  V  /  \  1  1  v_/ 1  \l ,  v_>/\  1  >l  1    1  l/\  1  M  V_*  1 0  V_/ V_y .  UrA      tOO  1  \J\JI  C  1  1  1  £_  1 

01/09/2013 

DO/SAN-CB/ 

MacroGenics 

2012-8783 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

John  Crewdson 

OBSERVATIONAL  POST-LICENSURE  SAFETY  STUDY  FOR 

01/09/2013 

\J  1  /  V/  C/  £_U  1  o 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1 V  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

PROJECT  ON  GOVERNMENT 

1     1  I  Nw/*J  1  \J  1     Vw/ 1  N    V/W  V  1  1  1 1  N  1  V  1  I  1  N  1 

ZOSTOVAX  IN  A  US  HEALTH  MAINTENANCE  ORGANIZATION 

FDA/OMPT/CDER/ORP/DIDP/ 

OVERSIGHT 

Vw/  v  i— _  i  i  VwJ  i      i  i  i 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 

ALFB/ 

2012-8784 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

John  Crewdson 

POSTMARKET  COMMITMENT  234570  -  ANNUAL  REPORT 

01/09/2013 

W  1  /  V/  C/  £_U  1  o 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  Vw/  1— /  1  1  1/  V_/  111    /  [_/  1  L/  1  / 

PROJECT  ON  GOVERNMENT 

1     1  I  Vw/O  1  \J  1     Vw/ 1  N    VJ  V/  VI  1  1 1  N  1  V  1  I  1  M  1 

(6/18/2012),  FINAL  REPORT  (12/30/2009) 

FDA/OMPT/CDER/ORP/DIDP/ 

OVERSIGHT 

Vw/  V  1— —  1  l  V/  1  V_/  1   1  1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 

ALFB/ 

2012-8785 

12/10/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Elisabeth  Neely 

P920015  S017 

Page  160  of  895 


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Total  Records:  9990 


V_/Ul  ill  Ul  TT 

Due  Date 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 

oiy i  icuui  t?/  ricLiutJoLci 

OUUJtfOl 

01/09/2013 

St.  Jude  Medical 

2012-8786 

12/10/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      I  /  \w/  L/  1  1  1/  \-s  III    /  1 — f  I  ]  /  I  / 

Shannon  Ppttvnippp 

ATORVASTATIN  -  AERS 

1  \  1  \S  1  I  V  1  V  Vw/  1  t  \  1  1  1  M        1  \  1  1  I  \S 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

BLOOMBERG  NEWS 

2012-8787 

12/10/2012 
01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \  '  L/  1  11   1/  \-s  w  l__  |  1/  I — /  |    Vw/  1/ 

E  Neely 

St.  Jude  Medical 

P920015  S090 

2012-8788 

12/10/2012 
01/09/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

L-/  V^/ /  1  N    1   i  \    IS  W  1  •  / 

Rebecca  Maciel 
FoodScience  Corporation 

ABH  NATURE'S  PRODUCTS,  FARMINGDALE,  NY  -  483 

(06/01/2012  -  06/^0/20121 

2012-8789 

12/10/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Merle  Zimmermann  (ext  106) 

NEW  DIETARY  INGREDIENTS  -  ALL  RECS 

01/09/2013 

OM/OMP/DODM/ 

AMERICAN  HERBAL  PRODUCTS 
ASSOCIATION 

2012-8790 

12/10/2012 
01/09/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Shannon  Pettypiece 
BLOOMBERG  NEWS 

ATORVASTATIN  -  CORR  BETWEEN  FDA  AND  RANBAXY, 
OHM  RE  NOVEMBER  2012  RECALL 

2012-8791 

12/10/2012 
01/09/2013 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

Shannon  Pettypiece 
BLOOMBERG  NEWS 

ENDO  HEALTH  SOLUTIONS,  QUALITEST  -  CORR  WITH  FDA 
RE  DECEMBER  2012  RECALL  OF  HYDROCODONE 
BITARTRATE  AND  ACETAMINOPHEN  TABLETS 

2012-8792 

12/10/2012 

1  t—l    1  \Jl  L—\J\C— 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  *wf  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Shannon  Ppttvnippp 

w l  l <zi  1  1 1  1  \J  1  1    1    wily  L/ltiUU 

BLOOMBERG  NEWS 

RANBAXY  LABORATORIES  OHM  LABORATORIES  TOANSA 

1  VI  \l  M  IS  1  \/\  1     1  1  \  \  )  \s  1  1 1  \  1  \s  1  1 1  1— —  *S  ,    Vw/  1   1 1 V 1    1  /  V  IS  Vw/  1  1 1  \  1  Vw/  1  11  1  \S  j     1  \  '  t  \  1  N  "SIX 

AND  PUNJAB,  INDIA  -  INSPECTION  RECS  (12/07/1995  - 
12/07/2012) 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  L*/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8793 

12/10/2012 
01/09/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

Doe  J 

GC  CORPORATION  (GE  AMERICA)  -  COMPLAINT  FOLLOW 
UP 

2012-8794 

12/11/2012 
01/10/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

OSO  BIOPHARMACEUTICALS,  ALBUQUERQUE,  NM  -  EIR 
4/12 

Page  161  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8795 

12/11/2012 
01/10/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      11  \J  L/  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

i    i  /  /  v/  \w/ 1  v  1 1     i  /  v  '  l/  i  i  i/  \w/  ill   /  I— /  1 1  /  i  / 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

LONZA,  BRAIN,  BELGIUM  -  EIR  6/12 

2012-879(5 

12/1 1/2012 

1  C—l    1     \  1  L—\J  1  L- 

01/10/2013 

FDA/OGROP/ORA/CE-FO/DET- 

1    L/  / V/  Vw/       1  i  w  |      V/  1  lrv\_/[        1    W;  1  '  1   1 

DO/DET-CB/ 

BRENDA  M  GARTZ 

i  > i  ii  i  ML/n  i v i .  uni  i  i  i— 

ELI  LILLY  &  CO 

EVONIK  DEGLJSSA  CORP  LAFAYETTE  INDIANA  -  EIR  3/12 

1      V  Vw/ 1  N  1 1  \  L./  1  V/  vJvJn  V/  Vw/  111    ,   1  nl    1  \  II       1    II  .    1  1  >J  l_/  1  / \  1  Mri       1  II  I  vJ/  1  i— 

2012-8797 

12/1 1/2012 

1  C—l    1     \  1  L—\J  1  L_ 

01/10/2013 

FDA/OGROP/ORA/CE-FO/DET- 

1    L-/  / V/  Vw/       1  I        1    /  Wl   l/x/\_/l        1    Vw//  L-/  1   1 

DO/DET-CB/ 

DpnniQ  R  f-iwaltnpv 

l/ui  ii  no  i  i-  \— ivvaiii  icy 

DePuy  Orthopaedics,  Inc. 

DEPUY  ORTHAPAEDICS  WARSAW  IN  -  EIR  (05/1 0/201 1  - 

1  '  1  1     LJ   1     KJ  1  1  1  1   1 1\  \    1  \  1  1  '  1  V/  V  '  ,    V  V  1  \  1  I      1  \  V  V  .    1 1  M         1  III    \\JxJI   1  \_//  C—  \J  1  1 

06/07/201 1 ) 

2012-8798 

12/11/2012 
01/10/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Justin  J.  Prochnow 
Justin  J.  Prochnow 

VARIOUS  PRODUCTS  -  CAERS  (07/01/2004  -  10/23/2012) 

2012-8799 

12/1 1/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  La/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

BRENDA  M  GARTZ 

1  )  1  l  1  1  il  L/ 1  \    1  V  1  ■         1  V 1  1  1  L  

GLAND  PHARMA  LTD  HYDERABAD  INDIA  -  EIR  8/1 2 

\-A  l—l     VI    N  La/      1        1      1  1    \  1     I  1  VI/     1      1          1     La/  .III      La/  1— —  |     1  1    \  \  '  1    \  IS  .       |  |         L/  1  /    V              l_  |  |     I     Vaf  /      1  L_ 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  L/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2012-8800 

12/11/2012 
01/10/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

GIRINDUS  AMERICA  INC,  CINCINNATI,  OH  -  EIR  2/12 

2012-8801 

t—\J  1  t—  \J\J\J  1 

12/1 1/2012 

1  C—l     1     If  L—  \J    1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  l_/  1  / 

Dr  Mirhapl  Spminprin 

L/  la    1  V 1 1  \j  1  1  QU  1    V/  V^  1  1  1 1 1  1  \j  1  1 V/ 

TARCEVA  -  STUDY  RESULTS 

1    I     \  1     l  Vw/  1           V    /     \              Vaa^    1  N— /  La/      1         1     1  1         \-)  \*J  \          1  Vw/ 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  CHICAGO 

2012-8802 

12/1 1/2012 

1  C—l     1     If  L—  \J    1  C— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  L/  1  La/  1  / 

..panna  M  Marraffa  Pharm  D 

U  UCll    1  1    1  CI      1  V  1      1  V  1  d  1    1    CI  1  1  CI      1        1    1  CI  1    Ilia  L/  a  a 

LOPERAMIDE  -  AERS 

1_  Vw/  1        1         1     VI     \  1  V  1  1  La/  1                    /     \  1         1     I  V»J 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  L/  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DABAT 

Upstate  NY  Poison  Center 

2012-8803 

12/11/2012 
01/10/2013 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

FISHER  CLNCL  SERVICES,  ALLENTOWN,  PA  -  EIR  1 1/1 1 

2012-8804 

12/11/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Andrea  Sudano  Roccaro 

ANTIBIOTICS  -  WEIGHT  LOSS  AND  AERS 

01/1 0/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  La/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OC/OES/DFOI/ 

Andrpa  Rudano 

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Action  Office 


Signature/  Requester 


Subject 


2012-8805       12/11/2012  FDA/OMPT/CDRH/OCER/DFOI/     Dr.  Salvador  Fornell  Prez 

01/10/2013  Dr.  Fornell.  Hospital  Virgen  del 

Rocfo 


EBI  OSTEOGEN  20  -  APPROVAL  RECS 


2012-8806 


12/11/2012 
01/10/2013 


F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 


Samuel  Medrano 
Private  Individual 


FRESENIUS  MEDICAL  CARE,  BATTLE  CREEK,  Ml  -  USE  OF 
GRANUFLO  AND  NATURALYTE,  SAFETY  ISSUES 


2012-8807 
2012-8808 


12/11/2012 
01/10/2013 
12/11/2012 
01/10/2013 


FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 


John  Chapman 

Stem  Cell  Partners  LLC  

KEITH  CHASIN 

LAW  OFFICE  OF  KEITH  CHASIN 


BK1 10040 


INDIVIDUAL  RECS 


2012-8809 


2012-8810 


12/11/2012 
01/10/2013 
12/11/2012 
01/10/2013 


FDA/OF/CFSAN/OCD/EOS/ 


FDA/OMPT/CDRH/OCER/DFOI/ 


Murray  Carpenter 
Murray  Carpenter 
ORI  GOREN 
MOVING  LIFE  LTD 


SUNKIST  SODA  -  CAERS  (09/01/2010  -  08/31/201 1) 


TZORA  ACTIVE  SYS  LTD  -  ELITE  ULTRA  LIGHT  COMPACT 
PORTABLE  SCOOTER  K052204;  FREEFIDER  LUGGIE 
SCOOTERS  INC  -  MODEL  1 68-41 T  K1 10165;  ELITE  EXTRA 
LIGHT  K052204 


2012-8811 

12/11/2012 
01/10/2013 

FDA/OF/CFSAN/OCD/EOS/ 

J.  ANDREW  MEYER,  Esq. 
MORGAN  &  MORGAN 

MARTEK  BIOSCIENCES  CORP  -  HORIZON  ORGANIC  MILK 
PLUS  DHA  OMEGA  3  DKT  2324 

2012-8812 

12/11/2012 
01/10/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

CHRISTOPHER  M.  SHKRELI 
GOLDBERG  SEGALLA 

FOREVER  CHEESE,  LONG  ISLAND,  NY  -  FRESCOLINA 
RICOTTA  SALATA  LISTERIA  OUTBREAK 

2012-8813 

12/11/2012 
01/10/2013 

CVM/OCD/ 

STEVE  D.  MATTERI 

CONTEMPORARY  PRODUCTS 
INC 

SICHUAN  LONG  MARCH  PHARMACEUTICAL  CO  LTD, 
LESHAN,  SICHUAN,  CHINA  -  EIR  9/09  TO  9/1 1 

2012-8814 

12/11/2012 
01/10/2013 

OC/OM/OMP/DDM/ 

THOMAS  FITZGERALD 

FSI  RESEARCH  &  SERVICES, 
INC. 

DKT  1976G-0445,  1977G-0049 

2012-8815 

12/11/2012 
01/10/2013 

OC/OM/OMP/DDM/ 

CHRIS  CELESTE 

EAS  Consulting  Group,  LLC 

DKT  1976N-0052 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8816 

12/11/2012 
01/10/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      At  \-S  IS  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L/  1  1  1/  > — /  III    /  1 — '  A  \S  A  1 

FDA/OMPT/CDER/ORP/DIDP/ 

JOHN  CREWDSON 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

MERCK  SHARPE  &  DOHME  CORP,  WEST  PT,  PA  - 
VACCINES  &  ALLERGENIC  PRODUCTS;  MERCK  SERONO 
SPA,  GUIDONIA  MONTECELIO;  MERCK  SHARP  &  DOHME 
CORP,  ELKTON,  VA  -  VACCINES  &  ALLERGENIC  PRODUCTS 
-  RVWS,  INSP 

2012-8817 

12/1 1/2012 

1  C—l   1    At  L—  \J  A  C— 

01/10/2013 

FDA/OGROP/ORA/SW-FO/DEN- 

1  1 — '  /  V/  \w/        1   I  \-s  A    I  Vw/  1   1  /  \/  V— '  V  V     1    \-S  1  I — ^  1  1  N 

DO/DEN-CB/ 

MIKE  SCHNEIDER 

1  v  1  1  1  V  1        \J  V/  1   1  1  it  1  1  L/  l__  1  I 

BOOKHARDT  &  0T00LE 

KASEL  DENVER  CO  -  INSP1 2/1 1  TO  PRESENT 

1  V/  V  Vw/  1  1  ,  1 — /  1  1  *J  V  1  1  1 1    V/  Vw/           1 1  N  O  1      1  C—l    1    1      1  \S    1     1  1 1_  O  l_  1  *J  1 

2012-8818 

12/11/2012 
01/10/2013 

FDA/OF/CFSAN/OCD/EOS/ 

D.  GREGORY  BLANKINSHIP 
MEISELMAN  DENLEA  ET  AL 

PLANT  STEROLS  -  STUDIES 

2012-8819 

12/1 1/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  l_/  1  1  1/  W  III    /  !_/  1  L/  1  / 

SUSAN  PRISET 

\S  K-S  \S  f\l  N     1      III  V/  1—  1 

SEMINAL  EVENT  RPT  FILED  BY  MD  ANDERSON  RE 

\S  1  1 V  1  1  1  *■  / \  1—    1       V  1  1  i  1     III      1     1     1  L_  1  (_/  1 — *  A     A  V  1  IS   1  \  1  >J  1 — /  1  1  I \S  Vw/  1  N    11 1  

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  A  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

HARTLEY  HAMPTON  PC 

INDIVIDUAL  REC 

2012-8820 

12/1 1/2012 

1  C—l     A     At  L—  \J    A  C— 

01/10/2013 

FDA/OGROP/ORA/SW-FO/DEN- 

1  1 — '  /  V/  Vw/  V/  1   I  V_/  1    /  Vw/  1  1/  \/  \s  V  V     1    V_//  L/  1  1  N 

DO/DEN-CB/ 

BRENTON  L  HORNER 

1  '  A  1 1—  1  N  1  V-/  Iv    1  ■    II  Vw/  [  1 1  VI  l_  1  I 

HORNER  &  ASSOCIATES 

CORR  BETWEEN  FDA  &  WORLD  HEALTH  PRODUCTS  LLC 

V/  Vw/  1  1 1  1  I— J  \       1    V  V  1  1  IN    1     L/ 1  \  IwA    V  V  Vw/  1  1 1  1  /    1   1  1  1  \  \       1  1   1    1     1  I  Vw/  L/  lw/  V/  1  v_/    1  1  V/ 

2012-8821 

12/1 1/2012 

1  C—l     A     At  L—  \J    A  C— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  l_  1  1/  1  /  1    Vw/  1/ 

AGA  MATRIX  K1 03544 

i  v /  v  ivin  i  i  ii/\  i\  i  v/ v/ v/  i  i 

01/10/2013 

FDA/OC/OES/DFOI/ 

LAM,  NELSON  . 

2012-8822 

12/12/2012 

1  C—l     A  C—l  L—  \J    A  C— 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  V/  1    v//\  1  N/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

MARILYNN  WHITNEY 

i vin i  iil  i  i  vi  i   v  v  i  ii  i  i  1 1_  i 

COVINGTON  BURLING  LLP 

COCA-COLA  -  CAERS  1/04  TO  PRESENT 

V/  Vw/  V/  /  V    V/  Vw/  1  I  \        V/ 1  \  I—  A  I V/     1  /  V/    i      1  Vw/    1     1  1 1  V_J  1  1  N  1 

2012-8823 

12/12/2012 

1  C—l    A  C—l  C—\J  I  L— 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    L/ / V/  Vw/  1    /  V_/  1    UrVI  >l/  V/V/L//  1  Vw/ Vw// 

MARILYNN  WHITNEY 

IV Ar^  1  111      1  1  N  1  N    VVI  II  1  INI   1 

COVINGTON  BURLING  LLP 

PEPSI  -  CAERS  1/04  TO  PRESENT 

1     1  1     \JA        V//  \  1  1  \\J     A  1              1  V_/    1     1  ll  V  '  1  IN  1 

2012-8824 

12/12/2012 

1  C—l   A  C—l  C—\J  I  L— 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    L/  / V/  Vw/  1    /  \_/ 1    UniM/v/vL'/  1  Vw/  VwJ/ 

MARILYNN  WHITNEY 

i  vin  i  hi     i           vvi  ii  i  i  mi   i 

COVINGTON  BURLING  LLP 

DR  PEPPER  -  CAERS  1/04  TO  PRESENT 

\—t  1  1    1     1  1     1     1  1  I        W/\l  1  IVj     l)U7     1  Vw/    1     1  11  \JA  IN  1 

2012-8825 

12/12/2012 

1  C—l   A  C—l  C—\J\C— 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    L/  / V/  Vw/  1    /  V_/  1    ijill  >l/  V/V/L//  1  Vw/  Vw// 

MARILYNN  WHITNEY 

i  vin  i  hi     i  i  n  i  n  vvi  ii  i  ini   i 

COVINGTON  BURLING  LLP 

MOUNTAIN  DEW  -  CAERS  1/04  TO  PRESENT 

1 V  lv_/  V/  1  N  1  /  V 1 1  N   L/  1  V  V        \w/  /  V 1  1  I  v  )    1  /  VJ*~r    1  Vw/   1    1  1 1  V/  1  IN  1 

2012-8826 

12/12/2012 
01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

MARILYNN  WHITNEY 
COVINGTON  BURLING  LLP 

STARBUCKS  COFFEE  -  CAERS  1/04  TO  PRESENT 

2012-8827 

12/12/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

HEK293  -  APRVL  RECS,  BRIEFING  RECS 

01/25/2013 

ALFB/ 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/OMPT/CBER/OCOD/DDOM/ 

WEAVER,  JOHN  D 

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Total  Records:  9990 


Pnntrnl  if 

nfciOU  L/cUt?  / 

Due  Date 

MOLIUll  wlllUc 

oiyiidLure/  rietjUebLci 

Ci  1  1  ["HQ/it 

ouujeoi 

ALFB/ 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

2012-8828 

12/12/2012 

1  C—l     A  L—l  L—  \J    A  L— 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    1  / 1  \!  \w/  1  v  1  1      A  1  \  '  1  J  1—  A  \l  Vw/  Vw/  Vw/  1— '  /  1  /  1 — '  W  1 V  1/ 

PER  C6  -  APRVL  RECS  BRIEFING  RECS 

1     1  II.  \J  \J        1  \  1     1  1  V  L   1  1 1  V/  v»J  j    1—J  III  l_  1     1 1  i|  Vw*1    1  I  L_  V_y  V/ 

01/25/2013 

ALFB/ 

WEAVER,  JOHN  D 

2012-8829 

12/12/2012 

1  C—l   A  C—l  C—\J\C— 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ROBERT  55  MOOUATE 

1  I V-/  1  '  1  1  1  1     V/    1  V  1  \_/ V-j(  VJ /\  1  1  

GRAS  ASSOCIATES  LLC 

FCN  73B 

1    \J  1  N    /  \J\J 

2012-8830 

12/12/2012 
01/11/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JASON  SMITH 

BEDFONT  SCIENTIFIC  LTD 

FIM  MEDICAL  -  TABATABA  CO  TESTER  CPT1 200508  RECS 

2012-8831 

12/12/2012 

1  C—l   A  C—l  C—\J  A  C— 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    A—I  i  \i  Vw/ 1 V  1  1      1  /  V/  A—f  1  1  1/  W  III    /  [_/  1  1— /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  \—J  1  1  1/  \-s  III    /  1  /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DOUG  DIX 

A—f  \J  VJ  \*A    L/  1  /\ 

UNIV  OF  HARTFORD 

CANNABIS  (MARIJUANA!  -  DRUG  ENFORCEMENT  APRVL 

uni  >i  i  inu  i  \j  uvini  iiuunnn/      l/i  iuu  i  i  ii  v_/i  i\_/i  ivii  i  m  i   ni   i  ivi  

RECS,  FDA  APRVL  RECS 

2012-8832 

12/12/2012 

1  C—l   A  L—l  L—  \J  A  l— 

01/11/2013 

FDA/OGROP/ORA/CE-FO/BLT- 

1  1— '  1  \l  Vw/  Vw^  1  1  Vw/  1    /  Vw/  1  1/  V  V/  l__    1    Vw//  L/  1   1 

DO/BLT-CB/ 

MELINDA  F  LEVITT 

miu  PROTOCOL  08-CH-0203  -  EIR  10/11 

I  N  I  1  1    1    1  1  Vw/  1  Vw/  V^/  V_/ 1      \JKJ    V-/  II    ULU  J       1  111    1  \JI  1  1 

2012-8833 

12/12/2012 
01/11/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

l/  v.//  i  w vi      v/ i_// 

Doe  J 

AFTERSHOCK  TATTOO,  OLATHE,  KS  -  TATTOO  RPT 

2012-8834 

12/12/2012 
01/11/2013 

FDA/0GR0P/0RA/PA-F0/L0S- 
DO/LOS-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

JENNIFER  CONNER 

AMERICAN  CLAIMS 
MANAGEMENT 

PRIME  ORTHOPEDICS  (PRIME  MEDICAL  RESOURCES)  - 
APPL,  DVC  LISTING  REGISTRATIONS,  LICENSING,  ETC  1/03 
TO  12/12 

2012-8835 

12/12/2012 
01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

ROMAN  LEBEDINSKIY 

TRAUB  LIEBERMAN  STRAUS  ET 
AL 

RAGE  RV3,  RAGE  RV5,  EPIO-PLEX,  ETC  -  CORR,  RECALL, 
RESP  TO  WARNING  LTR,  ETC  1 1/3/09 

2012-8836 

12/12/2012 
01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

STEPHEN  HELLER 
HELLER  LAW  FIRM 

BETANCOURT  NUTRITION  INC  -  RIPPED  JUICE  EX2 
CMPLNTS  CAERS  COMM  ETC 

v/ivii    i  i  m  i  \j  i  uni  i  i  vJ ,  vyVw/iviivi.  i      i  \j 

2012-8837 

12/12/2012 
01/11/2013 

FDA/OC/OES/DFOI/ 

Johnathan  Rickman 
FDA  NEWS 

FOIA  LOG  (12/03/2012  -  12/07/2012) 

2012-8838 

12/12/2012 

nn  /-t  1  lOCM  Q 
V\l\  \I£\J\  O 

F  D  A/OG  ROP/0  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OC/OES/DFOI/ 

Robert  M.  Goldman 
CL  King  &  Associates 

HILL-ROM,  INC,  BATESVILLE,  IN  -  483  (08/1 0/201 1  - 
12/10/2012) 

2012-8839 

12/12/2012 
01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 
ORA/ 

Richard  0.  Wood 

the  Wood  Burditt  group 

LIBRARY  INFORMATION  BULLETIN  4434  2;  ACTION  LEVEL, 
TOLERANCE,  OR  GUIDANCE  LEVEL  FOR  TETRACYCLINE  IN 
HONEY 

ORA/ 

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 1  1  II 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2012-8840 

12/12/2012 
01/11/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Gary  Syring 
QRAY  LTD 

K955589,  K010096,  K1 10556 

2012-8841 

12/12/2012 
01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \!  Vw/  1  v  1  1      1  /  \J  \—J  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Kii7?)nnp  O'fihpa 

» — '  l_1  £_  CI  1  II  1        Vw/  W  1  IUU 

FAEGRE  BAKER  DANIELS 

INO  THERAPEUTICS  -  FORMS  3542  AND/OR  3542A  RE  NDA 

1  1  N  V-/     1  1   1  1  1   VI  \  1     1  V/  1  1  V/  V/        1    Vw/  1  1 1  v  1  KJ              l  C—   / \  1  >l  1 — /  /  V_/  1  1      *_/        i  L_  /  \    1  1 1_    1  *J  I — '  1  \ 

20845  FOR  PATENTS  8,291 ,904  AND  8,293,284;  CORR 

2012-8842 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

Rprnip  Rumpcic; 

i— j v_s i  i  1 1 v./  l_ / m i  u^oo 

IND  49105  GCP  FILE  1840 

1  1  N  L*S      l  \J  1  \J\J    Vwi  V/  1       III—  1— —     1  V/  V/ 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BURGESS,  BERNIE 

2012-8843 

12/12/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  l_/  1  1  1/  W  III    /  (_/  1  l_/  1  / 

Starv  Wnpnnpl 

DIPRIVAN  (NDA  019627}  -  QUALITY  REVIEW 

1 — /  II      1    l  1  V  /   VI  *J     \  1  *J  1 — /  /   \    V/  |  \J  \_J  L_  /    f            vx  kw7  /   \  1  III      11  1        V  1  1— —  V  V 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

B.  Braun  Medical  Inc. 

2012-8844 

12/13/2012 

f\-t  M  A  /OA  ^  O 

01/14/^013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

Kelly  A.  Fitzpatrick 
The  Lanier  Law  Firm 

FRESENIUS  MEDICAL  CARE  -  GRANUFLO/NATURALYTE 
RECS,  CORR,  MDRS  ETC 

2012-8845 

fc-W  1  £_    V/  V/  I  v/ 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  L/  1  l_/  1  / 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   1  VJVJLV/Lf     1  \J  1 

ISR  7702455-3 

1  v  /  1  I      /    /  V/  £_     v/  v/  V/ 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/ 1  v  1 1      1  /  V/  \—J  1  1  1/  V_/  III    /  t — >  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

MERCK  &  CO.,  INC. 

2012-8846 

12/13/2012 
01/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Michelle  Meyer 
ATS  Labs 

K1 20306 

2012-8847 

12/13/2012 
01/14/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

Angela  STagg 
IMPULSE  DYNAMICS 

SURESH  NEELAGARU,  AMARILLO,  TX  -  EIR,  483 
RESPONSE,  FINAL  DETERMINATION  (10/10/2012  - 
10/19/2012) 

2012-8848 

12/13/2012 
01/14/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Kevin  D.  Tucker 
EXPONENT 

CONSULTATION  DOCUMENT  FOR  MON  87460 

2012-8849 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

Rarhpl  Johnson 

1  lClV.fl  lul   UUI  II  IOV/1  1 

ATROVENT  -  MEDICAL  OFFICER  REVIEW 

/  \  1  1  I  Vw/  V  1  1  M   1          1  V 1  1  1 — /  1  V/  /  V  L_  Vw/  1    1     1  V/  1  1  1    1  1 1_  V  1  1      V  V 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-8850 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Shannon  Pettypiece 

RANBAXY,  PUNJAB,  IN  -  483  2009,  201 1 ;  EIR  2000,  2003 

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\jU\  III Ul  tt 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  laLUl tf/  licLIUtJoLci 

OUUJtfOl 

Due  Date 

U  1/  1  *t/  C\J  1  O 

FDA/OMPT/nnFR/nRP/DIDP/ 
n  vj  r\i  v_/ivi  n  i  /  \_/ 1_/  r__  n/  \j  \  \  \  i  vj  i  vj  i  / 

Rl  OOMRFRn  NFW^ 

lj luuivi i— > i  n yj  wi  v v o 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  L- /  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

FnA/OMPT/nnFR/DRP/ninp/ 

n  vj  r\i  v_/ivi  n  i  /  \_/ 1_/  r__  rv     i  \  i  /  vj  1 1_/ 1  / 

2012-8851 

12/13/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

Michael  C.  Cotugno 

DYNALABS,  ST  LOUIS,  MO  -  483  MOST  RECENT 

01/14/2013 

DO/KAN-CB/ 

Cotugno,  Michael  C 

•j 

2012-8852 

12/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

JOETTE  GIOVINCO  MD 

KERATIN  COMPLEX  SMOOTHING  THERAPY,  KERATIN 

01/14/2013 

\J  1  /  1  T/  C—\J  1  O 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  VJ  1  1  1/  V_/  III    /  1— /  1  L/  1  / 

WTVT  FOX  1 3 

V  V   1    V    1     1    Vw/ /\     1  \J 

COMPLEX  PRODUCTS  -  AERS,  COMPLAINTS,  MONITORING 
STUDIES 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8853 

12/13/2012 

FDA/OF/CFSAN/OCD/EOS/ 

1  1— '  1  \i  Vw/  1    /  Vw/  1    v//\  1  N/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Rarhpl  Johnson 

FCN  527 

U  1/  1  t/    W  1  o 

FOI  ^prvippQ  Inr* 

1   WI  OCl  VlUt/o,   II  \Kj. 

2012-8854 

t—\J  1  t—  \J\J'Ji 

12/13/2012 

1  t—l     1  V//  L—\J\C— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  11   1/  Vw/ \J  l__  1  1/  1  /  1    Vw/  1/ 

Ppfpr  A  T?lkP9 

1     CLUI    l  \ .     1  UI\(/0 

K981783 

i  \\J\J  i  i  <j\j 

\J  1  /  1  ■+/ t.U  1  o 

r\y  |ji  id,  1 1 

2012-8855 

12/13/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

1  1 — '  /  V/  Vw/  Vw^  1   1  V_/  1    /  Vw/  1  IV  V/  V/  V  V     1    \J1  1  \/ VI  ^1 

1  1  1  \J  1  1  1  dO    V  V  a    \J  \J \J  \  \j  y 

DYNALABS  ST  LOUIS  MO  -  483  M2/1 2/201 1  -  12/1 1/20121 

LJ   1  1  *J  /  V  I—  /  \  1  t  \—J  1    V_J  1     L_  Vw/  \*J  1  VwJ  ,    1  V 1  Vw/          i  VJ  w    I    1  ^/    1       /  ^_  W  1    1           1  ^/    1    1  /  L_  \_/  1  l_  J 

01/14/2013 

DO/KAN-CB/ 

Cooley,  Thomas  W 

2012-8856 

12/13/2012 

FDA/OGROP/ORA/SW-FO/KAN- 

John  Fanikos 

DYNALABS,  ST  LOUIS,  MO  -  483  MOST  RECENT 

01/14/2013 

DO/KAN-CB/ 

Fanikos,  John 

2012-8857 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

Rqphpl  .Inhn^nn 

1  ICIV^I  1  *J  1   UUI  II  IOUI  1 

NDA203214 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

FDA/OMPT/HDFR/ORP/niDP/ 
n  vj  r\i  v_/ivi n  i  /  \j vj \  n/  v_/ 1  1 1  /  vj\vj\  i 

2012-8858 

12/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      it  V/  lw/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

John  Rpa^lpv 

UUI  II  1  UV7ut3  It*  y 

K1 00878 

1  \  1  V/V/VJ  / 

oi/i4/?on 

U  1/  1  tt/    W  1  o 

FDA/nn/nF^/nFm/ 

KyipHTprh  Rpvipw  1  1  C*. 
iviovj  i  cui  i  ncvicvv,  i_ i_ w 

C\J  I  C—  {J{J\JZf 

FDA/nnRDP/DRA/^W-FD/nFN- 

Raphpl  Inhncnn 
ridui  ici  jui  ii  loui  i 

FRpcpA  FDnnc;  i  ni  iisvii  i  f  r.n  -  4R3  wi 

i  ntoun  rvvuo,  i_v_/u i o  v  i i_i_ i  ,  uv/    too .  v v i_ 

01/14/2013 

DO/DEN-CB/ 

FOI  Services,  Inc. 

2012-8860 

12/13/2012 

rDA/OGROP/ORA/CE-FO/NWJ- 

Katie  Thomas 

RANBAXY  -  EIR,  483,  OORR  (01/01/2012  -  12/12/2012) 

01/14/2013 

DO/NWJ-CB/ 

NEW  YORK  TIMES 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  lw/  1  1  1/  V_/  III    /  (_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8861 

12/13/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

ShaeAnn  Cavanagh 

K050228 

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Reed  Date  / 
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Signature/  Requester 

Subject 

01/14/2013 

AGFA  Healthcare 

2012-8862 

12/13/2012 

i  C—l  i  v//  L—\J\t— 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Danipllp  Starr 
Foster  &  Eldridge 

IMPORTANT  DRUG  WARNING  CONCERNING  UNAPPROVED 

1  1 V  1  1     Vw/  1  l  1  I  \  1  V|  1     IS  1  I  V/  V_/    V  V  1  V 1   11  >l  1  1  N  V_^    V/  Vw/  1  *J  Vw/  1  1   II  *J  1  1  *l  V_/    V/  1  *J  l  \  1     1     1  I  \S  V  1  1 — / 

USE  OF  INTRAVAGINAL  OR  ORAL  MISOPROSTOL  IN 
PREGNANT  WOMEN  FOR  INDUCTION  OR  LABOR  OR 

2012-8863 

12/13/2012 
01/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \  '  L/  1  11   1/  \-s  \S  1—  1  1/  1 — /  1    Vw/  1/ 

Dr  Diane  Sudduth 

IS  1  ■    \S\CX\  1  V_/    V/UUUUU  1 

Biovance 

K1 02461 

l\l  V/  £_   l  V/  1 

2012-8864 

12/13/2012 

i  t—i  i  v// 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \J  IS  1  11   1/  Vw/  V/  l__  1  1/  IS  1    Vw/  1/ 

Dr  Diane  Sudduth 

IS  1  ■    IS  1 1  1  v/   V/UV/UUll  1 

K092191 

1  V  V/     1_  1  v/  1 

01/14/2013 

FDA/OC/OES/DFOI/ 

Biovance 

2012-8865 

12/13/2012 
01/14/2013 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Janice  Gardner 
ood  Safe  Pacific  LLC 

GATE  GOURMET,  INC,  HONOLULU,  HI  -  EIR  MOST  RECENT 
(01/02/2012  -  12/12/2012) 

2012-8866 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Amy  Shipley 

PHARMACIES  IN  FLORIDA  -  AERS,  COMPLAINTS 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  \S  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/ 

ORA/ 

The  Fort  Lauderdale  Sun-Sentinel 

2012-8867 

12/13/2012 

i  C—l  i  v//  t—\j\t— 

01/14/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

1    IS  1  \l  Vw/  V/  1   1  V_/  1    /  Vw/  1  IV  V/  V-/  V  V     1    V_//  1  W VI  i| 

DO/KAN-CB/ 

MICHAEL  ROYBAL 

1  v  1  1  V/  1   1 1  \  1  L_   1  1  Vw/   1  1  ^  / \  1  

ROYBAL  GLOBAL 

DYNALABS  -  483  2010  TO  2012 

IS   1  1  *J  /  V  L_  /  V  \S  V/            V/  O    L_  w  IV/     1  Vw/   L  W  1  £_ 

2012-8868 

12/13/2012 
01/14/2013 

FDA/OGROP/ORA/SW-FO/DAL- 

1    IS  1  \!  Vw/  Vw*1  1  I  V»/  1    I  Vw/  1  1/  V/  V/  V  V     1    \//  IS  1  \  1  

DO/DAL-CB/ 

MICHAEL  ROYBAL 

1  v  1 1  V/  1   1  /  V 1  1       1  l  Vw/   1  l_/  / \  l_ 

ROYBAL  GLOBAL 

ANALYTICAL  RESEARCH  LABS  -  483  2010  TO  2012 

/  VI  HI  V  l—  1     1  1  V/ /  V  L_   1  1 1_  V/  L_  1  \  \  I V/  1   1    1  /  \  1  '  \S            V/  V/  t_  V/  IV/     1  V-/   L_  V/  1  L— 

2012-8869 

t—\J  1  £—    UUU  J 

12/13/2012 

1  C—l    1  \JI  C—\J\L— 

03/12/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw/  1  J  l_  1  1/  Vw/  V/  V_/  I—/  /  1 — /  L/  V/  1 V 1/ 

ALFB/ 

CHARLES  CELESTE 

Vw / 1   1  /  \  1   ILLvJ    ULLLU  1  1— — 

EAS  Consulting  Group,  LLC 

GLAXO  SMITH  KLINE  -  INFANRIX  BL  103647  LBLG  APRVL 

V_H  I  /  V/\ Vw/   V/  Ivll  1  1   1    1              il  1             1  1  N  1    1  \  \  Hi   1  1  /  V    IS  l_     IV/  v/  \J   t  /     1  IS  I—  V_/  ^   /  V 1     1  I  V  l_  ■ 

CHEM  RVW 

2012-8870 

12/13/2012 
03/12/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw/  1  }  l__  1  1/  Vw/  V/  V_/  I—/  /  \S  \S  V/  1 V  1/ 

ALFB/ 

CHARLES  CELESTE 

Vw / 1   1  /  \  1   ILLvJ    ULLLU  1  1— — 

EAS  Consulting  Group,  LLC 

SANOFI  PASTEUR  -  DALTACEL  BL  103666  APRVL  LBLG 

Vw/  /  VI  *J  Vw/  1    1    1     /  V  Vw/  1  1  Vw/  1  l        L/ 1  \  \      1  /  V  V/  l_  1       IS  1—     1  V/ V/  V/ V/ V/  «V  1     1  1  V  L.    1  I  >  \  1 

CHEM  RVW 

2012-8871 

L_  \_/   1  £_    V/V/  /  1 

12/13/2012 

1  t—l    1  \JI  L—\J\S— 

03/12/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  1  )  l__  1  1/  Vw/  V/  Vw/  I—/  /  IS  IS  V/  1 V  1/ 

ALFB/ 

CHARLES  CELESTE 

V/  1   1 1  \  1  1  L_  1_  V/    V/  l__  1_  L_  V/  1  1  

EAS  Consulting  Group,  LLC 

GLAXO  SMITH  KLINE  -  ENGERIX  BL  103239  APRVL  LBLG 

V_/  1  /  \  /  V  \S    V/  Ivll  1  1   1    1  V  L_  1  1  *J  1             l_  1  VI  \S  l_  1  1  1  /  V   1  J  1         1  \J  v/^Xk/  */   /  V 1     1  I  V  L|    L_  IS  l_  V_/  , 

CHEM  RVW 

2012-8872 

12/13/2012 
03/12/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

CHARLES  CELESTE 
EAS  Consulting  Group,  LLC 

MERCK  &  CO  -  RECOMBIVAX  HB  BL  101066  APRVL,  LBLG, 
CHEM  RVW 

2012-8873 

L —  V/    1  L —     UV  /  ' 

12/13/2012 
01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

VETTER  PHARMA  FERTIGUNG  GMGH  &  CO, 
LANGENARGEN,  GERMANY  -  EIR  7/12 

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2012-8874 

12/13/2012 

1  C-l  1  yJI  C-\J  1  C 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \l  V_/ 1  v  1 1     11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

BRENDA  M  GARTZ 

1  >  1  11  1  ML/n    1  V  1 .    V_/ 1  \  \  \  \  L— 

VETTER  PHARMA  FERTIGUNG  GMGH  X  CO  RAVENSBURG 

VI       1    II  111     1   1 1  \  1  1 1  V  in    1     1  1  1  1  1  Vj  \J  1  N  \-A          1  V  1  VJ  1   1    VX   Vw/  Vw/  .    1  I  /  V  VI  IN  V  '  1  1  \J  1  \\*A  , 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V_/  1— /  1  1  1/  V-/  III    /  l_/  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

GERMANY -EIR  4/12 

2012-8875 

12/13/2012 
01/14/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

TECH  GROUP,  TEMPE,  AZ  -  EIR  10/1 1 

2012-8876 

t—\J  1  C    UU  /  Vj 

12/13/2012 

1  C-l  1  \Jl  L-\J  1  C 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  1  \l  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  1— /  1  L>  1  / 

BRENDA  M  GARTZ 

1  )  1  1  1  1  il  L-/ 1  \    1  V  1  ■    V_/ 1  \  1  1  1  £  

SANDOZ  KLJNDL  AUSTRIA  -  EIR  8/1 2 

\jr\\  >J  1— / Vw/ 1_ n   1  V kw/ 1  >l  1  1 1  ,  /  V kw/ v/  1  1  1 1 7  \       1  III  KJi  1  t_ 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  Vw/  III    /  1 — '  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2012-8877 

12/13/2012 
01/14/2013 

FDA/OF/CFSAN/OCD/EOS/ 

PETER  EISLER 
USA  TODAY 

PROTEIN  POWDER/SHAKE  FOR  MUSTLE  GROWTH  -  AER 

2012-8878 

12/13/2012 
01/14/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

FDA/OC/OE55/DFOI/ 

1   \-J  i\i  v/v//  Vw/ 1 — O/ 1— '  I  v_/ 1/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

MICHAEL  D.  MARRS 
CONYBEARE  LAW  OFFICE  P  C 

DR  SYBESMA,  LAKELAND  REGIONAL  HEALTH  SYS  - 
PLEXUR  M  BONE  GRAFT  AER 

2012-8879 

L—\J  1  C             1  J 

12/13/2012 
01/14/2013 

FDA/OC/OE55/DFOI/ 

1    \-J  l\l  V/  V//  V_/l — O/  1— '  1    v_x  1/ 

BRODY  MULLINS 

1 — '  1  1  Vw/  1 — /    1     1 V  1  Vw/  1  E  1  1  4  \J 

WALL  STREET  JOURNAL 

WEDBUSH  SECURITIES  -  FOI  1/10  TO  PRESENT 

V  V  1  1— /  1  >  \J  v_>  1   1    vJ  1  V_/       1  1 1  1  1  1  \J        1    V_/  1     1  /    1  \J     1  V_/    1     1  1 1  w  1  1  N  1 

2012-8880 

12/13/2012 

ORA/ 

ELCE  M.  ROGERS 

CMPLNT  128733 

01/14/2013 

ORA/ 

Dymatize  Nutrition 

2012-8881 

t—\J   1  L—    KJKJKJ  1 

12/13/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw/  lw/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

KAYLEE  WHITE 

E  V/  \  1  1  l__  l_    V  V  1   II  1  1— — 

MEDWATCH  7853733  7853742 

1 V  1 1  ]  /  V  V  /  \  1  V— '  1   1    /  UvU  /  V/ V/  .     /  V/  v/ V/  /     i  i— 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SALAMANDRA  LLC 

2012-8882 

12/13/2012 
01/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  lw/  1  11   1/  W \J  l_  1  1/  1  /  1    Vw/  1/ 

VINEET  SARIN  PhD 

V    1  1   *J  1        1          1       o  1    \  I    1 1 1   *J  ,      1       II  lw/  , 

KINAMED  INC 

KINAMED  INC  CAMARILLO  CA  -  K032950  K010101 

1  V  I  1  *J  l  \  1  v  1  1  1 — /    1  1  il  Vw/  ,    V  '  /  \  1  VI/  VI   III—  I—  Vw/  ,    V/ 1  \        1  V  \_/  v/ 1_  >»/  v_/  V/  n    1  \  V/  1  V/  1  V/  1  . 

K994214  NON  REDACTED 

2012-8883 

12/13/2012 
01/14/2013 

OC/OM/OMP/DDM/ 

JENNIFER  PELAIA 
COVINGTON  BURLING  LLP 

DKT  FDA-2012-P-0904 

2012-8884 

12/13/2012 
01/14/2013 

FDA/OO/OFBA/OAGS/ 

Fay  Barnes  -  IQ  Solutions 
IQ  Solutions 

OFFICE  OF  WOMEN'S  HEALTH  RFTOP  NATIONAL  WOMEN 
AND  GIRLS  HIV/AIDS  AWARENESS  DAY  2013  -  RFP, 
STATMENT  OF  WORK,  MONTHLY  REPORTS,  ETC. 

2012-8885 

12/13/2012 
01/14/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Doe  J 

INDIVIDUAL  RECS 

2012-8886 

12/14/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

Dustin  Strickland 

GREER  LABORATORIES,  INC,  LENOIR,  NC  -  COMPLAINT 

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01/15/2013 

DO/ATL-CB/ 

GREER  LABORATORIES,  INC. 

2012-8887 

12/14/2012 
01/15/2013 

ORA/ 
ORA/ 

Amy  Shipley 

The  Fort  Lauderdale  Sun-Sentinel 

FLORIDA  PHARMACIES  -  INSPECTIONS  2009-2012; 
INFUPHARMA  .  INSPECTION  RECS  CORR  SINCE  7/30/12 

1  1  N  1    '  1  1     1   1 1  \  1  1 1  VI/  1        1  1  M  ■  '  1     1  \J  1  1  (  i  1  M    11 1  V  '   '  ,    \J  \  '  1111   1  >  1  1  1|  — <  1        I  /  \J\Jl    1  C— 

O  A  H  O  OOOO 

2012-8888 

A  i~i  M  A  /OA  -1  A 

1  2/1 4/201 2 
01/15/2013 

rUA/OMr  I  /OUKH/UOtK/UrOI/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Julie  Donnelly 

Boston  Business  Journal 

JUUbt  KU  1  tNBtKCa  tUUOA  1  lUNAL  OtN  1  tH,  OAN  1  UN,  MA 
-  UNTITLED  LETTER  (05/23/2011) 

2012-8889 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  \J  1— /  1  1  1/  W  III    /  [_/  1  1  '  1  / 

SLJPPRELIN  LA  IMPLANT  -  SIDE  EFFECTS 

UUI    1    1  11  l_  1 1  M   1  1  \   llvll    1  1  \ 1  N  1        vJIL/l       1  1    1    1  \J  1  vj 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    1  '  1  \i  Vw/ 1 V  1 1      1  /  \_/  1— /  1  1  1/  V- '  III    /  1—/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-8890 

12/14/2012 
01/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Steve  Pardue 
Elevate  Oral  Care 

K092141;  K090519 

2012-8891 

12/14/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

Dr.  Paul  Knoepfler 

CELLTEX,  RNL  BIO,  HUMAN  BIOSTAR,  ETC  -  APPROVAL 

01/15/2013 

ALFB/ 

FDA/OC/OES/DFOI/ 

UNIVERSITY  OF  CALIFORNIA, 
DAVIS 

RECS 

2012-8892 

12/14/2012 
01/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Marcia  L  Zucker 
ZIVD,  LLC 

K121679 

o  a  -i  o  oo  ao 

2012-8893 

^  O  M  /I  /OA  ^  O 

1  2/1  4/201 2 
01/15/2013 

rUA/UMr  1  /O  1  r/UU/ 

Ryan  Meyer 

HAGENS  BERMAN  SOBOL 
SHAPIRO  LLP 

UP  A  A  A  A  A  A  O     l_l /"» A  A  A  A  A  A"7    l_l A  A  A  A  A  A  O  [Z  ~T/^ 

HG0000048,  HO0000067,  HU0000068  1 1  0 

2012-8894 

12/14/2012 

ORA/ 

INDIVIDUAL  RECS 

01/15/2013 

ORA/ 

Doe  J 

2012-8895 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — f  I  J  /  I  / 

Trim  Rrakpl 

1  Ul  1  1    1  '  1  Clival 

RELISTOR  -  AERS 

1  1 1  1  1        1  V_/  1  1        1  \  1  1  l\J 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Federated  Investors 

2012-8896 

12/14/2012 

1  C—l   1  TV  £_  W  1  4— 

ORA/ 

Chri^tv  Wi^rnan 

\j iiiioiy    v  v  iooi  i  iui  i 

WHITEWAVE  FOOD  MOUNT  CRAWFORD  VA  -  TEST 

V  V  1   II  1  1      V  V  /  \  V  1—    1    Vw/  Vw/  I — '  y    1  V 1  Vw/  V/  1  >l  1     \-S  1  1 1  \  V  V  1    V/  1  1  L/  ^     V  1  V         1  l_  \^/  1 

01/15/2013 

ORA/ 

WhiteWave  Foods 

RESULTS 

2012-8897 

12/14/2012 
01/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Nguyet  Tran 
Tran  Law  Offices 

USP  LABS,  LLC  -  WARNING  LETTER  (CERTIFIED) 

2012-8898 

12/14/2012 

1  l—/   1  TV  £_  W  1  ft— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/ 1  v  1 1      1  /  V/  L/  1  11   1/  V_/  w  l__  1  1/  1 — /  1    Vw/  1/ 

Kpvin  Ri ittprfipld 

K914190 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Butterfield  Technologies,  LLC 

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Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8899 

12/14/2012 
01/15/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Heather  Neely,  Sr.  Director  RA/QA 
Kinamed,  Inc. 

KINAMED,  INC,  CAMARILLO,  CA  -  UNREDACTED  EIRS 

(05/25/1993-  12/11/1997) 

2012-8900 

12/14/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 

K040985 

01/15/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-8901 

12/14/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Dale  A.  Scott 

FOUR  LOKO  -  GRAS  REVIEW,  CORR,  SETTLEMENTS,  ETC 

01/15/2013 

OC/COS/OES/ 
OC/COS/OES/ 
FDA/OC/OES/DFOI/ 

Bell  &  Roper,  P. A. 

2012-8902 

12/14/2012 
01/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

David  Lin 

Shoprider  Mobility  Products,  Inc. 

MW5027704  SHOPRIDER  STREAMER  SPORT  POWER  CHAIR 

MOREI    GQJ3WA     QPRIAI    Ml  IMREP    nATEQ  OP  I  IQE 
IVIVJUCL  OoOVVM  -  OCrilML  IMUIVIDCri,  UMI  Co  \Jr  UoC 

2012-8903 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Alison  Mann  Stuebe 

ISR  6617751,  6902283,  7016471,  ETC 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNC  School  of  Medicine 

2012-8904 

12/14/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Alison  Mann  Stuebe 

DOMPERIDONE  -  FAERS 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNC  School  of  Medicine 

2012-8905 

12/14/2012 
01/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Dale  A.  Scott 
Bell  &  Roper,  P. A. 

PHUSION  PROJECTS  -  CORR  RE  MANUFACTURE  AND 
SALE  OF  ALCOHOLIC  BEVERAGES  CONTAINING  CAFFEINE 
(1 1/13/09);  CITY  BREWING  CO  -  CORR  RE  MANUFACTURE 
AND  SALE  OF  ALCOHOLIC  BEVERAGES  CONTAINING 
CAFFEINE  (11/13/09) 

2012-8906 

12/14/2012 
01/15/2013 

ORA/ 
ORA/ 

CVM/OCD/ 

Kristina  Worsham 
Worsham,  Kristina 

DIAMOND  PET  FOODS,  KIRKLAND,  COSTCO  -  COMPLAINTS 
FILED  IN  COLORADO  (01/01/2012  -  12/13/2012) 

2012-8907 

12/14/2012 
01/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Julie  Donnelly 

Boston  Business  Journal 

JUDGE  ROTENBERG  EDUCATIONAL  CENTER  -  UNTITLED 
LETTER  (06/29/2012) 

2012-8908 

12/14/2012 

ORA/OE/ 

George  Ball 

MEDICAL  DEVICE  RECALL  DATA  (1994  TO  PRESENT) 

01/15/2013 

ORA/OE/ 

UNIVERSITY  OF  MINNESOTA 

2012-8909 

12/17/2012 
01/16/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JONATHAN  REEVES 
MAKO  SURGICAL  CORP 

ORTHOSOFT  INC  -STEROTAXIC  INSTRUMENT  K071714 

2012-8910 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

JONATHAN  REEVES 

BLUE  BELT  TECHNOLOGIES  -STEROTAXIC  INSTRUMENTS 
K121936 

Page  171  of  895 


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01/16/2013 

MAKO  SURGICAL  CORP 

2012-8911 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

DAVID  WARNICK 

BOSTON  SCIENTIFIC  -  SPINAL  CORD  STIMULATOR  FORM 

01/16/2013 

MARK  A  ADAMS  LLC 

3500A  9/1/10  TO  10/31/10 

2012-8912 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JEFFREY  A  ROWE 

□SITING  OF  MORPHINE  PRODS  2002 

01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Kill  mni  i\/  ni  n — ni — ni — 11 — i  r~\  o 

MURPHY  BUTTERFIELD  & 

FDA/OMPT/CDER/ORP/DIDP/ 

MULLANU  rO 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8913 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

GARDINER  HARRIS 

LUPIN  LTD,  BHOPAL,  INDIA  -  1 1/12/08;  ZENOTHECH 

01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

NEW  YORK  TIMES 

LABORATORIES  LTD,  ANDHRA  PRADESH,  INDIA  -  1/21/09; 

STERICON  PHARMA  PVT  LTD,  BANGALOR,  KARNATAKA, 

FDA/OMPT/CDER/ORP/DIDP/ 

INDIA  3/1 7/1 0,  ETC  -  EIRS,  483S,  WARNING  LTRS  LISTED  IN 

FDA/OMPT/CDER/ORP/DIDP/ 

THE  NDC  DIRECTORY 

FDA/OC/OES/DFOI/ 

2012-8914 

12/17/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ELENA  HOWELL 

SANDOZ  INC  -  VORICONAZOLE  (INJECTABLE  IV  INFUSION) 

01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

HOGAN  LOVELLS  US  LLP 

NDA  90-0862,  (  TABLET  ORAL)  NDA  20-0265  CHEMISTRY 
RVWS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-8915 

12/17/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

MICHAEL  P  KRENSAVAGE 

RTI  BIOLOGICS-483 

01/16/2013 

DO/FLA-CB/ 

Krensavage  Asset  Management 

2012-8916 

12/17/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 

WALTER  BROZOWISKI 

SANDOZ  -  PARENTA  BRAND  METHOTREXATE  PROD 

01/16/2013 

DO/NWJ-CB/ 

COKER  SCHICKEL  SORENSON 

RECALL  1/1/03  TO  12/12/12 

FDA/OMPT/CDER/ORP/DIDP/ 

ET  AL 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/SW-FO/DEN- 

DO/DEN-CB/ 

2012-8917 

12/17/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

KATE  WILLSON 

RTI  BIOLOGICS  -  483  6/25/12  TO  7/11/12 

01/16/2013 

DO/FLA-CB/ 

CENTER  FOR  PUBLIC  INTEGRITY 

rUA/UIVIr  1  /Obtn/UOUU/UIJUIVI/ 

lAUM  PDC\A/CnAM 

JUMIN  L/hibWoUUIN 

MtAL  I  n-UAnt  rriUVIUtrib  -  VAtrio 

01/16/2013 

ALFB/ 

PROJECT  ON  GOVERNMENT 

OVERSIGHT 

2012-8919 

12/17/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

JOHN  CREWDSON 

SHINGLES  PREVENTION  STUDY  -  VAERS 

01/16/2013 

ALFB/ 

PROJECT  ON  GOVERNMENT 

OVERSIGHT 

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Subject 

2012-8920 

12/17/2012 
01/16/2013 

FDA/OF/CFSAN/OCD/EOS/ 

GARDINER  HARRIS 
NEW  YORK  TIMES 

VIET  SPICES  COMPANY  LTD,  MY  PHUOC  TOWN,  VIETNAM  - 
9/21/10;  INDIAN  CHILLIES  TRADING  COMPANY  LTD, 
VIRUDHUNAGAR,  INDIA  -  8/25/1 1 ;  SWANI  SPICE  MILLS  PVT 
LTD,  NAVI  MUMBAI,  INDIA  -  7/1 9/1 1 ,  ETC  -  EIRS,  483'S, 
WARNING  LTRS 

2012-8921 

12/17/2012 
01/16/2013 

FDA/OF/CFSAN/OCD/EOS/ 

BOBBY  SHCHOCHET 

OLSSON  FRANK  WEEDA 
TERMAN  BODE  MATZ 

INFANT  FORMULA  NOTIFICATION  -  CORR,  MINS,  EXHIBITS, 
ETC  6/1/1 2  TO  PRESENT 

2012-8922 

12/17/2012 
01/16/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-4541,  2012-4575,  2012-4694,  ETC 

2012-8923 

12/17/2012 
01/16/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Lakshmi  Padmanabhan 

St.Jude  Medical  Neuromodulation 

P840001/S076,  P840001/S063,  P960009/S035 

2012-8924 

12/17/2012 

1  C—l    lit  L—  \J   1  ft— 

01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Chri^  Rlowp^ 

Vw/ 1  II  IO    1  /  1  \J  V  V  \j  o 

Celgene  Inc 

NDA  022393  (ISTODAX^  -  CROSS  DISCIPLINE  TEAM 

1  *l  1 — /  I  \  \J  C—  L—  \J  \J  \J    I  1  \-J  1  Vw /  l—/ 1  \  /  V  f        V/  1  I W/VJ    l_/  1  V/  V/  II     l_  1  1  il  l_     1  L_  1  \  \  v  1 

LEADER'S  REVIEW,  MEDICAL  REVIEW,  STATISTICAL 
REVIEW,  ETC 

2012-8925 

12/17/2012 

1  *— /     lit  L—  \J    1  L— 

01/16/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1     1  / 1  \!  Vw/  1  v  1  1       1  /  \  '  1  J  1—  1    1/  Vw/  Vw/  Vw/  1— /  /  1  /  1  /  Vw/  1 V 1/ 

ALFB/ 

.lulip  M  Fnrtp 

Ono  Pharma,  USA,  Inc. 

CBER  BIOLOGICAL  RESPONSE  MODIFIERS  ADVISORY 

V/  I  )  \         |     I      1  )  \  Vw/  l_  Vw/  \J  |  V/ 1    \  1_      |     1  l_  K-f  1  Vw /  |   >|  V/  1— —      1  V  1  Vw /  L/  |  |        |  l__  |     I              /    \  l_/    V    1  Vw^  Vw /  III 

COMMITTEE  MEETING  -  PRESENTATION  SLIDES  (07/24/97) 

2012-8926 

t-v/  1  £—  v. '  v/  t_  \J 

12/17/2012 

1  *— /   lit  L—  \J  1  *— 

01/16/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

1  ak^hmi  Padrnanahhan 

LUfXO  1  1  1  1  1 1    1     CIVwJ  1  1  IQI  IQUI  1  CI  1  1 

St.Jude  Medical  Neuromodulation 

P970003/S065 

2012-8927 

12/17/2012 

1  *— /    lit  L—  \J   1  L_ 

01/16/2013 

FDA/OMPT/CTP/OD/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  1  1    /  Vw/  1  /  / 

PAUL  MENDOZA 

1     i  \  V/  1       1  V 1  1  1  *J  1  /  Vw/  £  1  \ 

COMPANIA  TABACALERA  S.A 

COMPANIA  TABACALERA  -  LISTING  OF  INGREDIENTS  IN 

V/  Vw/  1 V 1  1    I  \  \  *l  1  /  \     1  I  \  \  '  I  \  V_/ 1  \  \  1  1  1  /  V        1_  1  Vw/  1  1  1  M  V_/    Vw/  1       1  1  \  V_/  1  1 1  L/  1  1  1  N  1  Vw/    1  1  *l 

TOBACCO  PRODUCTS 

2012-8928 

fc-V/    1  £—    V/  yj  I— 

12/17/2012 

1  *— /     lit  L—  \J    1  *— 

01/16/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1  1 — '  /  V/  Vw/  1    /  V/  1    V/  /  V 1  VI/  Vw/  Vw/  1 — /  /  l_  Vw/  U/ 

Kpitv  Kinn 

i  vt7 1  i  y   i  v  1 1  i  ka 

Intertox,  Inc. 

ODWALLA  INCIDENT  REPORT  M0/30/96V  PATHOGEN 

Vw/  l  /  V  V  /  \  1  l_/  V    1 1  V|  V/  |  I — /  I  1  VI  1     11 1_  1     Vw/  III     11  V//  V/  \J  1  \J  \J  J  )    1    /  \  1  1   1  Vw/  V^/  1  1  N 

LEVELS  OF  LISTERIA  IN  APPLES  (AUGUST  201 2) 

2012-8929 

12/17/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Tito  Jankowski 

K1 00040 

01/16/2013 

FDA/OC/OES/DFOI/ 

Self 

^01^-8930 

^  o  /^  "7  /oa  ^  o 

1  <;/1 7/^01 2 
01/16/2013 

rUA/OO/Utb/UFOI/ 

\A/!ii  « 

will  Ooggin 

CENTER  FOR  CONSUMER 
FREEDOM 

cNVIKUNIVItN  1 AL  WOKKINCj  bKUUr  -  rOIA  KtOUtb  1  o 
(01/01/2012  -  12/14/2012^ 

2012-8931 

t—\J  1  t—  \J\J\J  1 

12/17/2012 

1  *— /    lit  L—  \J   1  L_ 

ORA/ 

INDIVIDUAL  RECS 

1  1  VI  L/  1  v  1  1  f  V/  /  \  1—    1  I  L_  V/  V/ 

01/16/2013 

ORA/ 

Doe  J 

2012-8932 

12/17/2012 

ORA/ORM/ 

David  Mangione 

LIST  OF  INSPECTIONS  (11/22/2012-  12/15/2012) 

01/16/2013 

ORA/ORM/ 

Govzilla,  Inc. 

2012-8933 

12/17/2012 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Bruce  Metzger 

DUTCHLAND  FOODS,  LESTER,  IA  -  INSPECTION  RECS 
(11/25/2012  -  12/15/2012) 

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Signature/  Requester 

Subject 

01/16/2013 

Bruce  Metzger 

2012-8934 

12/17/2012 
01/16/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ditza  Auerbach 
ditza  auerbach 

K082268 

2012-8935 

12/17/2012 
01/1 6/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \l  \S  1 V  1  1      1  /  \S  IS  1  1   If  W  III    /  L*/  1  L/  1  / 

oc/occ/ 

Stephen  Handal 
Indpnpndpnt 

06/22/12  MEETING  BETWEEN  ELIZABETH  DICKINSON  AND 
KURT  KARST  -  MEETING  MINUTES,  AMARIN  RECS 

2012-8936 

12/17/2012 

1  C—l    III  L—  \J   1  L_ 

01/16/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

.lohnathan  Rirkman 

%J\JI  II  Id  LI  ICll  1    1  M\_/[VI  1  ICU  1 

FDANEWS 

FOIA  REQUEST  LOG  M  2/1 0/201 2  -  12/14/20121 

1    Vw/  1 1  \    1  1 1  V_*(  \S  1  V/  1     L_  Vw/  \S\    1    I  £_/    I  V//  £_  V/  1  L—          1  £-/    1  ^Ti  t—  \J  1  c_  J 

2012-8937 

12/18/2012 
01/17/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Michael  Holbert 

Clean  Coating  Technologies  LLC 

K101128 

2012-8938 

12/18/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \!  Vw/  1  v  1  1      1  /  \  '  IS  1  1  1/  \s  III    /  1 — '  1  L-/  1  / 

.lanpt  MrOhri^tion 

w  CI  1  IUL    IvIVjV/I  II  IOLIV/1  1 

ANDA  079197  ANDA  200771  ANDA  202063  ETC- 

/  VI  *J  IS  1  \  \J  1  \J  1  \J  1  ,    I  \  1  *l  IS  I  \  C—  \J  \J  II    1  ,    /  VI  M  \S  1  \  L—  \J  L—\-/  \J  w  <    l_  1  V/ 

01/17/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1     IS  1 \!  \S  1  V  1  1       1  /  V/  L*S  1       1    1/  \-S  III     /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Fresenius-kabi  LLC  USA 

APPROVAL  LTRS 

2012-8939 

12/18/2012 
01/17/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1 \!  Vw/  1  v  1  1      11  \  '  L/  1  11   1/  Vw/  V/  l_  1  1/  IS  1    Vw/  1/ 

Marie  Gptrhpll  OrpSMDI  LLC 

1  v  1  CI  1  1 VZ   Vw^i  wlvl  1  *j  1 1  ■    Vw/ 1  \jKJ  1 V 1  IS  1    1  1  \S 

Cre8MDI  LLC 

K070795 

1  XV/  1  \J  1  \J\J 

2012-8940 

12/18/2012 
01/17/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      II  V/  L/  1  11   II  V_/  V/  l_  1  1/  IS  1    Vw/  11 

Marie  Gptrhpll  OrpSMDI  LLC 

1  v  1  CI  1  1  \j    \S\  V_-  v\j  1  1 1>  1  1  1    Vw/ 1           1 V  1  IS  1    L_  L_  Vw/ 

Cre8MDI  LLC 

K080670 

1  V  V/  V/  v/  V/  /  \J 

2012-8941 

12/18/2012 

1  t—l    1  \JI  L—\J\t— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1 \!  Vw/  1  v  1  1      1  /  V/  IS  1  11   1/  V-/ \J  1—  1  1/  1  /  1    Vw/  1/ 

Qfpup  ParHiip 

K041482 

1  V  V/       1       V/  c_ 

01/17/2013 

FDA/OC/OES/DFOI/ 

Elevate  Oral  Care 

2012-8942 

12/18/2012 

1  t—l    1  VJ/  LU  1  L 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1 \l  Vw/  1  v  1  1      1  /  V/  IS  1  11   1/  V_/  \S  1—  1  1/  1 — /  1    Vw/  1/ 

Marie  Gptrhpll  OrpSMDI  LLC 

1  v  1  CI  1  1  \j    \S\  Vj  v\j  1  1  \j  1 1  1    Vw/ 1  t>  V/  1 V  1  L/  1    1  1  \—> 

K013434 

1  \VV   1  V_/    1^  V-/  1^ 

01/17/2013 

FDA/OC/OES/DFOI/ 

Cre8MDI  LLC 

2012-8943 

12/18/2012 

ORA/ 

Jen  Wieczner 

DRUG  PRODUCT  CLASS  1  RECALLS  (01/01/2005  -  12/17/2012) 

01/17/2013 

ORA/ 

Dow  Jones/MarketWatch 

2012-8944 

12/18/2012 

FDA/OC/OES/DFOI/ 

Traci  S.  Umberger 

PHYSIO-CONTROL,  INC  -  HEALTH  HAZARD  EVALUATION 

01/17/2013 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

PHYSIO-CONTROL,  INC. 

RE  LIFEPAK  20,  20E 

2012-8945 

12/18/2012 
01/17/2013 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

Traci  S.  Umberger 
PHYSIO-CONTROL,  INC. 

PHYSIO-CONTROL  INC,  REDMOND,  WA  -  HEALTH  HAZARD 
ANALYSIS,  483  10/24/12 

2012-8946 

12/18/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

JoNel  Aleccia 

RTI  BIOLOGICS,  ALACHUA,  FL  -  INSPECTION  RECS, 

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Reed  Date  / 
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Subject 

01/17/2013 

DO/FLA-CB/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OC/OES/DFOI/ 

NBCNews.com 

WARNING  LETTERS,  CORR  (12/17/2005  -  12/17/2012) 

2012-8947 

12/18/2012 
01/17/2013 

OM/OMP/DODM/ 

Jennifer  Brown  (2642660) 
INFOTRIEVE 

ORALLY  INHALED/INTRANASAL  CORTICOSTEROIDS  AND 
GROWTH  IN  CHILDREN  (1998) 

2012-8948 

12/18/2012 

1  C-l   1  KJI  C-\J  1  C 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  IS  1 1  '  1  / 

i  ilipnp  A  Pattern 

L—IIICll  IC  l  \  1    CllLVJI  1 

FORTEO  -  AERS 

I   Vw/ 1  i  i  i  Vw/      i  \  1  i  I  >  ; 

01/17/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Patton,  Liliane  A 

2012-8949 

12/18/2012 
01/17/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OC/OES/DFOI/ 

LARA  WEISS 

GOLDBERG  &  GILLE  LAW  OFCS 

FRANCK'S  COMPOUNDING  LAB,  OCALA,  FL  -  BRILLIANT 
BLUE  G  DYE  RECS 

2012-8950 

12/18/2012 
01/17/2013 

OM/OMP/DODM/ 

MICHAEL  G  REIN 
WELDON-LINNE  &  VOGT 

DERMATOLOGIC  AND  OPHTHALMIC  DRUGS  A/C  -  TRANS 
9/19/00  (CERTIFIED) 

2012-8951 

12/18/2012 

FDA/OGROP/OIP/ 

CARMEN  S  SCOTT 

MIRENA  -  AERS  1/09  TO  PRESENT,  CONTACT  RPTS,  LBLG, 

01/17/2013 

\J  \  1  1  /  /  t—\J  1  \J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \w/  Lri/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  L^/  1  Lri/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

MOTLEY  RICE  LLC 

ETC 

2012-8952 

12/18/2012 

ORA/ 

JOHN  L  HOLAHAN 

SIMPLYTHICK  PRODS  -  TEST  RESULTS,  SAMPLING 

01/17/2013 

ORA/ 

SIMPLY  THICK  LLC 

2012-8953 

12/18/2012 
01/17/2013 

ORA/ 
ORA/ 

INGRID  S  MARTIN 
COLLORA  LLP 

NEW  ENGLAND  COMPOUNDING  PHARMACY  (NEW 
ENGLAND  COMPOUNDING  CENTER)  -  PROD  SPLS  TEST 
RESULTS 

2012-8954 

12/18/2012 

1  C-l  1  (_>/  L-\J  1  C 

01/17/2013 

CVM/OCD/ 

Cnnqtanrp  N  Whitp  DVM  PhD 

WL/I  Id  LCI  1  IOC    IN,    V  V  1  1 1  IU  1— /  V  IVI    1     II 1  ' 

Fremont  Veterinary  Clinic 

ENALAPRIL  CNADA  1410151 

I  I  >i  1  \  I  1  \  I    I  1 1 1      V '  "  ** **    1   ■  I  u  1  \j  J 

2012-8955 

12/18/2012 

1  C-l   1  KJI  £—\J  1  t— 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

Yi i-. Ii i  Ohipnn 

i  u  ju  \j  i  iicii  i  y 

K001948  K080670  K020537 

01/17/2013 

FDA/OC/OES/DFOI/ 

Chung  Yuan  Christian  University 

2012-8956 

12/18/2012 

1  C—l   1  KJI  t—  KJ  1  C— 

01/17/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \l  \w/  1  v  1  1      1  /  \  '  Lri/  1  11   1/        \J  l_  1  1/  1 — /  1    Vw/  1/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

GREG  L  DREVENSTEDT  PHD 

\-A  1  1  1  \J    1       IS  1  1  1       V  1  1  *J  V_J  1  1  1 — /   1     1     1   1  i_/ 

VALMONT  RESEARCH  LLC 

DENTAL  DVC  IMPORTERS  -  807  41  ESTABLISHMENT 

1 — /  1  Ivl  /  \  I       IS  V  \S    1  1 V  1  1     \S  1  1  1  1  1  I  \S        \J\J  1  m    l    1     l_  v-*  1  1  V  L_/  1  1  Vw^  1   1  1  V 1  1  1  il  1 

REGISTRATION  AND  DVC  LISTING 

2012-8957 

12/18/2012 
01/17/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

ALKERMES,  WILMINGTON,  OH  -  EIR  1 1/4/1 1 

2012-8958 

12/18/2012 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

BRENDA  M  GARTZ 

DSM  PHARMS,  GREENVILLE,  NC  -  EIR  4/1 1 

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ELI  LILLY  &  CO 

2012-8959 

12/18/2012 
01/17/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

DSM  PHARMS,  GREENVILLE,  NC  -  EIR  4/12 

2012-8960 

12/18/2012 
01/17/2013 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

Traci  Umberger 
PHYSIO-CONTROL,  INC. 

PHYSIO-CONTROL  INC,  REDMOND,  WA  -  HEALTH  HAZARD 
ANALYSIS,  483  (10/24/12) 

2012-8961 

12/18/2012 
01/17/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

201 0-7504,  201 1  -1 983,  201 1  -5035,  ETC 

2012-8962 

12/18/2012 
01/17/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-1613,  2012-1963,  2012-1976,  ETC 

2012-8963 

12/18/2012 
01/17/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-6067,  2012-6477,  2012-6663,  ETC 

2012-8964 

12/19/2012 
01/18/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

debra  g  speyer 
speyer,  debra  g 

BAY  IMAGING  GROUP,  NORTH  FLORIDA  -  INSPECTION 
REPORTS,  MQSA  REVIEW,  SUPERVISING  PHYSICIAN,  ETC 
(01/1 0/2008  -  12/31/2009^ 

^01<;-o965 

^  a  m  a  /oa  ^  o 

1  9/^01 
01/18/2013 

rUA/UUKOrVUKA/bt-rU/A  1  L- 
DO/ATL-CB/ 

OM/OMP/DODM/ 

Thano  Maceo  Paris 
Thano  Maceo  Paris 

^□AnU  UACDITAI       ATI    AMTA          A       IMODCPTIAM  DCD/^DT 

(jKAUY  HUbrl  1  AL,  A 1  LAN  1  A,  bA  -  INbrtG  1  ION,  HtrOK  1 
OF  THE  PUBLIC  BOARD,  TRANSCRIPT 

2012-8966 

12/19/2012 

ORA/ 

Jennifer  Szymanski 

RENASTART  -  DISPOSAL  OF  RECALLED  PRODUCT 

01/18/2013 

ORA/ 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

Vitaflo  USA 

2012-8967 

12/19/2012 
01/18/2013 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

PHILIP  MORRIS/ALTRIA  -  CORR  RE  L&M,  MARLBORO  NXT, 
MARLBORO  SELECT  KING  SIZE  (06/22/2009  TO  PRESENT) 

2012-8968 

12/19/2012 

ORA/ 

Gloria  Candelario 

SAMPLE  RESULTS 

01/18/2013 

ORA/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

N/A 

2012-8969 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

Joan  Stitt  (UG2CD-16} 

ISR  8337594-X 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MERCK  &  CO.,  INC. 

2012-8970 

12/19/2012 

FDA/OC/OES/DFOI/ 

KEN  REID 

2011-708,  2012-5498,  2012-5584,  ETC 

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2012-8971 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-8193,  2012-8215,  2012-970,  ETC 

2012-8972 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-987,  2012-965,  2012-8187,  ETC 

2012-8973 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-5587,  2012-5496,  2012-8227,  ETC 

2012-8974 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

201 1  -1 471 ,  201 2-967,  201 2-5558,  ETC 

2012-8975 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-5517,  2012-964,  2012-5562,  ETC 

2012-8976 

12/19/2012 
01/18/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

2012-973,  2012-5683,  2012-8203 

2012-8977 

12/19/2012 
01/18/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

CARDINAL  HEALTH  COLTON  CA-EIR  12/11 

Vw//  V 1  l  L/  1  1  il  l  \  1       1   1  1  /  \  1      1   1   1  j    V/  Vw/ 1_  1  Vw/  IN,    Vw/  /  V        l_  III     1  £-/    1  1 

2012-8978 

L—\J   1  t—    \J\J  1  \J 

12/19/2012 

1  t—l    1  \J  1  L—\J\S— 

01/18/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

BRENDA  M  GARTZ 

1  f  \  1 1_  1  N  1  J  1  \   \  V  1    V_/  /  VI  1  1  c.  

ELI  LILLY  &  CO 

ANALYTICAL  BIOCHEMISTRY  LABS  COLUMBIA  MO  -  EIR 

/  VI  HI  \  1       III  \—S  i  \  \       1  )  1  Vw/  V/  1   1  l_  1 V 1  1  V/  1  1  1  1     l—l  V 1  '  K-f  ,    V/  Vw/  1—  Vm/  1 V 1  1  )  1  /  V  ^    1  V 1  Vw/        l_  111 

12/16/11 

2012-8979 

12/19/2012 
01/18/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

BAXTER  PHARMACEUTICAL  SOLUTIONS,  BLOOMINGTON, 
IN  -  EIR  9/12 

2012-8980 

12/19/2012 
01/18/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

JANICE  M  HOGAN 
HOGAN  LOVELLS  US  LLP 

SPINALMOTION  INC  -  KINEFLEX  C  CERVICAL  ARTIFICAL 
DISC  P10001 1  PANEL  HOMEWORK  ASSIGNMENTS, 
RISK/BENEFIT  W/S 

2012-8981 

12/19/2012 
01/18/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

ANDREA  N  WALLEN 

DELPHINUS  MEDICAL 
TECHNOLOGIES  INC 

U-SYSTEMS  INC,  SUNNYVALE,  CA  -  AUTOMATED  BREAST 
ULTRASOUND  SYS  P1 10006  RECS 

KJ  1—  1  1  1 1  \  V/  Vw/  Vw/  1  *J  1 — '    V/  1  V/    1      1    1  W  V/  V/  V/    1  1 1—  V/  VwJ 

2012-8982 

12/19/2012 
01/18/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

BRENTON  LORNER 
HORNER  &  ASSOCIATES 

WORLD  HEALTH  PRODUCTS  LLC  -  DETOXAMIN 
SUPPOSITORIES  CORR,  RESP  TO  LTR  12/12.11 

2012-8983 

12/19/2012 
01/18/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

KAREN  ANDERSON 
WBZ-TV 

SPECIALITY  MINERALS  INC  -  7/24/12;  PHARMALUCENCE  INC 
-  4/25/12;  AMAG  PHARMACEUTICALS  INC  -  5/24/12,  ETC 
483S 

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2012-8984 

12/19/2012 
01/18/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

AYAMI MARUYAMA 
CANON  INC 

REDIFORCE  RX840-MG  -  K1 20451 

2012-8985 

12/19/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \J  \S  1  1  1/  \-s  III    /  I — '  1  IS  1  / 

ELLIOT  FAVUS 

l__  1  1  1  V-/  1     1    /  V  v  V/  Vw/ 

PONATINIB  -  AERS  1/10  TO  PRESENT 

1     Vw/ 1  *J  1  \  1  1  1  VI  1  IS        1  \  l__  1  l  \_j     1  /    1  \J     1  Vw /    1     1  I l_  Vw/  1  1  N  1 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  IS  1  1  1/  > — /  III    /  1 — '  1  !_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FAVUS  INSTITUTIONAL 
RESEARCH  LLC 

2012-8986 

12/19/2012 
01/18/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Doe  J 

UNILEVER  -  WISHBONE  SALAD  DRESSING  CMPLNT 

2012-8987 

12/19/2012 
01/18/2013 

ORA/OE/ 
ORA/OE/ 
ORA/ORM/ 

Vw /  1  1 1  \i  \SJ  1  1 1 V  1  / 

ORA/ORM/ 
ORA/OE/ 

\*s  i  i  / v  Vw/ 1 — / 

ORA/OE/ 

Kevin  McCoy 
USA  TODAY 

FOOD  FACILITIES,  BOTTLED  WATER  PLANTS  -  LIST  OF 
INSPECTIONS,  RECALLS  (07/18/2006  -  12/18/2012) 

2012-8988 

12/20/2012 
01/22/2013 

FDA/OGROP/ORA/CE-FO/BLT- 

1    IS  1  \!  Vw/  V/  1  I  V_/  1    /  Vw/  1  1/  V/  \w/  l_    1    Vw//  1  J  1   1 

DO/BLT-CB/ 

WALTER  E  CHALKLEY 

V  V  1  \  1—  1  1—  1  l    1  ■    Vw/  1   1/  V  1_  1  V  1_  l_  1 

THOMSON  REUTERS 

OCTAPHARMA  PLASAM  INC  VIRGINIA  BEACH  VA  -  EIR  483 

Vw/  Vw/  1  /  V 1     1   1 1  \  1  1 1 V  1 1  \    1     1— / \  V_/ 1  \  1  VI    111  Vw/  y     VIII  V_/  II       / \    1  /  1  /  V  Vw/  1   1  j     V  /  1        l_  II  I ,        V/  v/ 

2/3/12 

2012-8989 

12/20/2012 
01/22/2013 

FDA/OGROP/ORA/SE-FO/FLA- 

1    IS  1  \!  Vw/  \J  1  1  Vw/  1    /  Vw/  1  1/  V/  V/  1— —    1    Vw//  1    l_/  V 

DO/FLA-CB/ 

WALTER  E  CHALKLEY 

V  V  1  \  1—  1  1—  1  l    1  ■    Vw/  1   1  /  V  1_  1  V  1_  l_  1 

THOMSON  REUTERS 

MIRAMAR  COSMETICS  INC  DORAL  FL  -  EIR  483  1/3/12 

1 V  1  1  1  1 1  \  1  V  1 1  \  1  I    Vw/  Vw/  V/  1  V 1  1       1  1  V-/  \S    1  1  M  V/  ,    IS  Vw/  1  1  /  \  L_ ,    1    1            l_  II  I ,        V/  V/     1  /  V//    1  £_ 

2012-8990 

12/20/2012 
01/22/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

1    L/ 1  \l  Vw/  V/  1  I  V_/  1    /  Vw/  1   It  \/  1    / \    1    \*/t  L—  V_/  V/ 

DO/LOS-CB/ 

WALTER  E  CHALKLEY 

V  V  1  \  1—  1  1—  1  l    1  ■    Vw/  1   1/  V  1_  1  \  1_  l_  1 

THOMSON  REUTERS 

EXPERT  CHEMICAL  ANALYSIS  INC  SAN  DIEGO  CA  -  EIR 

1  /  V  1     1  III     V/  1   1  l_  1  V 1  1  V/  /  V  L_  /  \  1  N 1  \  1—  1  V/  1  Vw/    1  1     \S>  ,    Vw/  /  \  1  *J  1 — '  1  1  V^/  Vw/  j    Vw/  /  V        l_  II  I . 

483  1/28/11 

2012-8991 

L—\J    1  £_     \J\S\J  1 

12/20/2012 

1  t—l  L—\JI  L—\J\t— 

01/22/2013 

FDA/OGROP/ORA/NE-FO/NYK- 

1    ]  /  /  V/  Vw/  V/  1  1  \w/  1    /  Vw/  1  If  V/  1  VI  1—    1    Vw//  1  *l    1    1  V 

DO/NYK-DCB/ 

WALTER  E  CHALKLEY 

V  V  1  \  1—  1  1—  1  l    1  ■    Vw/  1   1  / \  1_  1  V  1_  l_  1 

THOMSON  REUTERS 

ALKABELLOINC  PORT  WASHINGTON  NY -3/21/12 

/  V  l—  1  \  1  V  IS  1  L_  1_  Vw/    1  1  i|  Vw/  j    1     Vw/  III      V  V  /  V  Vw/  1   1  1  1  N  V_/  I  Vw/  1  i|  ,    1  V  1          V//        1  /    1  £_ 

2012-8992 

12/20/2012 

1  t—l  t—  \JI  t—\J\t— 

01/22/2013 

FDA/OGROP/ORA/PA-FO/SEA- 

1  1 — '  1  \l  Vw/  V/  1   l  V_/  1    /  Vw/  1  IV  V/  1    / \    1    \„//  V/  l_  / \ 

DO/SEA-CB/ 

WALTER  E  CHALKLEY 

V  V  1  \  1—  1  1—  1  l    1  ■    Vw/  1   1/  V  1_  1  V  1_  l_  1 

THOMSON  REUTERS 

PETNET  SOLUTIONS  KENT  WA  -  EIR  483  2/12 

1     1       1  1  x  1       1     *S  V_/  [_  V/  1  1  Vw/ 1  >J  Vw/  .    IV  1  1  *J   1   ,     V  V  /  \        l_  II  I .      r  VJ  O   t—l    1  L_ 

2012-8993 

12/20/2012 
01/22/2013 

F  D  A/OG  ROP/0  R  A/C  E-  FO/B  LT- 
DO/BLT-CB/ 

WALTER  E.  CHALKLEY 
THOMSON  REUTERS 

JUBILANT  CADISTA  PHARMACEUTICALS,  SALISBURY,  MD  - 
EIR,  483  3/14-23/12 

2012-8994 

12/20/2012 
01/22/2013 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

WALTER  E.  CHALKLEY 
THOMSON  REUTERS 

TISSUE  BANKS  INT'L,  MEMPHIS,  TN  -  EIR,  483  6/18-20/12 

2012-8995 

12/20/2012 

i  t—t  t—  v// 1 —  \j  i  l — 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

WALTER  E.  CHALKLEY 
THOMSON  REUTERS 

SHANGHAI  HUHUI  DAILY  USE  CHEMICAL  PRODUCTS, 
SHANGHAI,  CHINA  -  EIR,  483  2/6-10/12 

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2012-8996 

12/20/2012 
01/22/2013 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

WALTER  E.  CHALKLEY 
THOMSON  REUTERS 

SALEM  HOSPITAL  IRB,  SALEM,  OR  -  EIR,  483  6/6-25/12 

2012-8997 

12/20/2012 
01/22/2013 

r  U  A/U(j  KOr/U  KA/b  t- r  U/r  LA- 
DO/FLA-CB/ 

FDA/OC/OES/DFOI/ 

\A/AI  T[Z  n  d    AUftl  l/l   [Z \/ 

WAL  1  tK  t.  GHALKLtY 
THOMSON  REUTERS 

H  1 1  BIOLOGICo  INC,  ALACHUA,  rL  -  tIK,  48a  6/26-7/1 1/12 

2012-8998 

12/20/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  / 1  \!  Vw/  1  v  1  1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

RUTH  RIZKALLA  Esa 

1   \  \S  1  1   1    1  ll^_l  V 1  \  L_  l_/  \^    1  O  VJ  ■ 

rhBMP-2  -  LICENSE  APPLICATION 

1  1  1  IS  1 V 1  1       L—        1  1  \s  1—  1  VI  \w/  1        /  V 1     1     1  1  V_/ 1  \  1  1  Vw/  1  \ 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  \J  \S  1  1  1/  \-s  III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SIZEMORE  LAW  FIRM  PLC 

2012-8999 

12/20/2012 

1  t—li—\JlL—\J   1  £— 

01/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

i    ]  /  /  v/  \w/ 1  v  1 1     i  /  \  '  Lh'  i  ii  i/     ■  v  '  i_  i  i/  i  /  i    \w/ 1/ 

ALEX  VEIZIS 

I  \  1  1  /  \     V  1  1 L  1  \S 

FDALIVE.COM 

CHDR  ADVISORY  COMMITTEE  MTG 

Vw/  1   1  IS  1  l  I  \  IS  v  1  \S  Vw/  III     Vw*  Vw/ 1 V  1  1  v  1  1  1    1  1  1        1 V 1  1  \S\ 

2012-9000 

12/20/2012 
01/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JURGEN  KALBER 
MEDENTIKA  GMBH. 

Tl  BASE  ABUTMENT  -  NT  TRADING  GMBH  AND  CO  KG, 
CLAREMONT,  NH  -  K1 1 1935 

2012-9001 

12/20/2012 

FDA/OGROP/ORA/SE-FO/FLA- 

CMPLNT  120110 

01/22/2013 

DO/FLA-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OC/OES/DFOI/ 

GISSENDANNER,  ROBIN 

2012-9002 

12/20/2012 

1  t—l  t—  \Jl  L—\J\t— 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \m/  L- /  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  W  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ANDREW  017561,  JOHN 

SELENIUM  SULFIDE  LOTION'  GELENIOM  SOLFIDE  TOPICAL 

Vw/ 1  i  i  i  vi  i  \j  l  v  i  Vw/  *s  i  i    i  iw/  i__  i_  Vw/  i  i  Vw / 1  >i  ,  Vwi  i_  t_  i_  i  vi  i  Vw/ 1  v  i  u  Vw/ 1_  i    1 1 — /  i        i  w  i    i  v/  /  v  i_ 

SUSPENSION  -  RECALL 

2012-9003 

12/20/2012 

1  t—l  L—  \Jl  t—\J\C— 

01/22/2013 

FDA/OC/OES/DFOI/ 

1     *S  1  \!  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1     \_/  1/ 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  11/26-30/12 

IS  1  VI  1       1     1  V_/           1    1  /  £_  V/        \JI    1  £_ 

2012-9004 

12/20/2012 

1  t—l  L—\J1  L—\J\L— 

01/22/2013 

FDA/OC/OES/DFOI/ 

1    *S  1  \!  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

i_/  v  Vw/ 1  1 1— _  i  *i  Vw/  ■  i  i  /  \  i  1 1  i 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  11/19-23/12 

IS  t  VI  1       1     ^V/sJ     1    1  1    \  \J    L—  Vw*/    1  £_ 

2012-9005 

12/20/2012 

1  t—l  C—  \Jl  L—\J\t— 

01/22/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

1  1  \  V/  1    l  1— —  1  VI    Vw/  ■     1  '  /  \  1    l  1  l 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  12/10-14/12 

Iw/  /  VII—  1     l_  V^/  V_^1     1           1  \J      1  T/    1  L— 

2012-9006 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S.  BARR 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  12/3-7/12 

2012-9007 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  12/3-7/12 

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Subject 

2012-9008 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  12/10-14/12 

2012-9009 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

DAVID  MacFARLAND 

FDA  WEBVIEW/FERDIC  INC 

DAILY  LOG  12/3-7/12 

1 — /  /  V  1  l_  1     1_  V_/  V_^1     1  £_/          III  C— 

2012-9010 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

DAVID  MacFARLAND 

FDA  WEBVIEW/FERDIC  INC 

DAILY  LOG  12/10-14/12 

2012-901 1 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

i  i  v_/  / \    i  /  v  i  ii  ii  \—j  v^/ 1  *j   \_)  Vw/ 1  1 1  i  /  \  i  v  1 1 

CanReg,  Inc. 

DAILY  LOG  12/3-7/12 

l_/  /  V 1  1       1     1  V_/           1         v/    III  L— 

2012-9012 

C—  \J  1  £_    \J\J  1  L— 

12/20/2012 

1  t—li—\JlL—\J   I  I— 

01/22/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARRISON-SCHRAMP 

1  1  V/ 1  \     1  1 V 1  1 1  1 1  \J  v^/  1  N         V_/  1   1  1  1 1  \  1  V 1  1 

CanReg,  Inc. 

DAILY  LOG  12/10-14/12 

2012-9013 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

DAILY  LOG  12/10-14/12 

L«//  VII—  1     1  V_/           1           1  V/     1     i/    1  l_ 

2012-9014 

12/20/2012 
01/22/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

DAILY  LOG  12/3-7/12 

2012-9015 

12/21/2012 
01/23/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Lelia  M.  Fuentes 
CARDINAL  HEALTH 

POSITRON  EMISSION  TOMOGRAPHY  DRUG 
MANUFACTURERS  -  EIRS(1 2/31/201 0  -  12/31/2012) 

2012-9016 

12/21/2012 
01/23/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    J  /  /  V/  Vw/  1  v  1  1      11  \J  l—s  1  11   1/  V»/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

Kimhprlv  Ri  ill^ 

1  V 1 1  1  1 KJ  \^  1  1  y  UNO 

TECHLAB,  Inc. 

K090700 

1  Wl/V  /  \J\J 

2012-9017 

12/21/2012 
01/23/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L- /  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

Kimhprlv  Ri  ill^ 

1  \  1 1  1  1  kJ Vj  1  IV    1  '  U  1  IO 

TECHLAB,  Inc. 

K974651 

2012-9018 

12/21/2012 
01/23/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Lena  Gomez 

Keller  and  Heckman,  LLP 

CAFFEINE  INTAKE  BY  THE  US  POPULATION 

2012-9019 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JOSEPH  WALKER 

INCIVEK  -  AERS 

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01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Dow  Jones  &  Company 

2012-9020 

12/21/2012 
01/23/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \J  L*S  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

OM/OMP/DODM/ 

FDA/OC/OES/DFOI/ 

Emily  Bartkowicz 

AKERMAN  SENTERFITT  ATTYS 

TOPICAL  ANTIFUNGAL  DRUG  PRODUCTS  FOR  OTC  HUMAN 
USE  -  MEDICAL  LITERATURE,  JOURNALS,  TESTING,  ETC; 
KRAMER  LABORATORIES,  KRAMER  CONSUMER 
HEALTHCARE  -  CORR  WITH  FDA 

2012-9021 

12/21/2012 
01/23/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \m/  L-/  1  11   1/  V^-*  \w /  l_  1  1/  1 — /  1    Vw/  1/ 

Kimhprlv  Ri  ill^ 

1  \  1 1  1  1  Ks  \^  1  IV  I— J  U  1  1  O 

TECHLAB,  Inc. 

K093295 

2012-9022 

12/21/2012 
01/23/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Leslie  H.  Joyner,  Esq. 
Marlin  &  Saltzman 

HANSEN'S  PREMIUM  DIET  SODA  WITH  ALL  NATURAL 
FLAVORS  -  ALL  RECS 

2012-9023 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  L-/  1  1  1/        III    /  1 — '  1  L-/  1  / 

Raphpl  Johnson 

1  IGlVtSl  1  V- '  1   UUI  II  1  Jul  1 

WELLSPRING  ONTARIO  CANADA  -  OAP 

V  V  1— —  1  L_  VwJ  1     1   1  1  1  >l        n    \—S  1  *J  1  1  \  1  1 1  V- /  ,    \_J  f\  1  *l  / \  1  J 1 \        VX/ V 1 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  W  III    /  1 — '  1  L*/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2012-9024 

12/21/2012 

FDA/OMPT/CBER/OCOD/DDOM/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  1  }  1—  1  1/  \—s  \w/  W  L-/  /  1 — /  1 — ^  \w /  1 V 1/ 

Dnmininup  Huff 

L/UI  1  1 1 1  1  lu      \J    1   IU  II 

PLASMA  DONATION  -  STATISTICAL  DATA 

i    i—i       i  vi/  v  i—/ v*/ 1  v i  \  i  i  Vw/ 1  m      \j  i  i  \  i  i  Vw^  i  i     /  \ i   i— / y  \  i  v \ 

01/23/2013 

ALFB/ 

Home  Rule  News 

2012-9025 

12/21/2012 
01/23/2013 

FDA/OO/OFBA/OAGS/ 

Reindeer  Charities 
Goedert,  Matthew  D 

STOP  GRANTS  -  JOIN  TOGETHER  NORTHERN  NEVADA 
APPLICATION 

2012-9026 

12/21/2012 
01/23/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Alexandra  Ajmo 
LIFE  EXTENSION 

LIFE  EXTENSION,  NATURE'S  VALUE  INC,  GEMINI 
PHARMACEUTICALS,  ETC  -  EIRS 

2012-9027 

12/21/2012 

1  C—l  C—  1  1  L—  \J  1  C— 

01/23/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

RO  Wood 

the  Wood  Burditt  group 

PRESERVATION  SOLUTIONS  INC  ELKHORN  Wl  -  483  482 

i    i  1 1  \j  i  i  i  v  i  \  i  i  v_y  i  >i  Vw/     1  \_j  i  i  v_y  i  v \j  1 1  n  \j  ?  i  i»  i  \  i  i  \w/ 1  1 1    ,   v  v  i        i  \*j    ,         l_  , 

EIR  ETC 

2012-9028 

12/21/2012 
01/23/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Wendell  Tong 
Tong,  Wendell 

STYKER  REJUVENATE,  STRYKER  ABG  -  SUBMITTED  RECS, 
REVIEWS,  ADVERSE  EVENTS  ETC 

2012-9029 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

PREDISONE,  ONCOVIN,  MECHLORETHAMINE  HCL,  ETC  - 
MFRS  ADDRESS,  DRUG  INTERACTION  RECS  1981  TO  1985, 

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Subject 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \J  L- /  1  1  1/  \-s  III    /  I — f  I  L-/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

CRISSEP  #1258732,  KENNETH 

ETC 

2012-9030 

12/21/2012 

1  L—l  L—    1  /  C—  \J    1  L— 

FDA/OC/OES/DFOI/ 

1    I—'  1  \l  Vw/  Vw//  Vw/  1 —  \JI  L-/  1    VwX  1/ 

LATESHA  R  BAKER 

1  J  \  \  1—  \-J  1   1 1  V    1  l    L_/  /  V 1  \  l_  1  I 

AVASTIN  (BEVACIZUMAB^  INJ  MIAMI-DADE  COUNTY  FL  - 

/  \  V  /  \\J  1  1  1  il    1  1  '  1—  V  1  \  ■ — /  1 C  Vw^  1  VI/  V 1—}  )    1  1  »U  f    Ivll  1  \  1  V 1  1  1— /  /  \  L-/  1        V_/  Vw/  Vw^  1  v  1     1^1  1  

01/23/2013 

HINSHAW  &  CULBERTSON  LLP 

RECS  7/1 1 

2012-9031 

12/21/2012 
01/23/2013 

FDA/OC/OES/DFOI/ 

i    l/  i  \l  Vw/  Vw//  Nw/ 1 —  vj/  i— /  i  Vw/ 1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  10/8-12/12 

1    Vw/  1    l_//  V 1  L_  1     l_  Vw/  V^l     1  V/ /  V/     1  ^/    1  L_ 

2012-9032 

12/21/2012 

1  C—l  L—    1  /  C—  \J    1  L— 

01/23/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  10/1-5/12 

1    Vw/ 1    l_//  V 1  L_  1     LVM     1  \J  1   1     \J1    1  L_ 

2012-9033 

12/21/2012 
01/23/2013 

FDA/OC/OES/DFOI/ 

1  1— '  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  10/15-19/12 

1    Vw/ 1    l_//  V 1  L_  1     L_  Vw/  V^l     1  \JI   1  v/     1  v//    1  C— 

2012-9034 

t—\J  1  t—    v/  V/  V/  1 

12/21/2012 

1  C—l  L—    1  /  C—  \J    1  L— 

01/23/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  10/22-26/12 

1    Vw/  1    l_/ /  V  1  L_  1     L_ Vw/  V^l     1  \J I  L—  £_    C^\JI    \  C— 

2012-9035 

12/21/2012 

1  C—i  C—  1  1  C—  \J  1  C— 

01/23/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  10/29/12-11/2/12 

1    Vw/  1    l_/  /  VI  1       1     L_  Vw/  V^l     \  \Jl  L—  \J  1    \  t—      \    \  1  C^l    1  L— 

2012-9036 

12/21/2012 

1  C—l  L—    1  /  C—  \J    1  L— 

01/23/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  11/5-9/12 

1    Vw/  1    l_/  /  V 1  1       1     L_  Vw/  V^l     1    1  /  \_/        /    1  L 

2012-9037 

12/21/2012 

1  C—l  C—  1  l  C—  \J  1  C— 

01/23/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  11/12-16/12 

1    Vw/ 1    l_/  /  VI  1       1     L_  Vw/  V^l     1    1  /   1  L—      \  \Jl    \  C— 

2012-9038 

12/21/2012 
01/23/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  11/19-23/12 

2012-9039 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

JOHN  MANCINI 

DECADRON  PHOSPHATE  INJ,  DEXAMETHASONE  SODIUM 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  V»/  III    /  1 — '  1  !_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ARIZONA  STATE  HOSPITAL 

PHOSPHATE INJ  -  AERS 

2012-9040 

12/21/2012 
01/23/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

ORA/OCI/ 

ORA/OCI/ 

Anderson,  Carl 

GAVIN  SMITH,  PRECISION  PEPTIDES,  LUTZ,  FL  -  SALE  OF 
PEPTIDES,  ANABOLIC  STEROIDS,  HUMAN  GROWTH 
HORMONE  COMM  1/1 1  TO  PRESENT 

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2012-9041 

12/21/2012 
01/23/2013 

CVM/OCD/ 

Douglass  Oeller 

Douglass  Oeller  Consulting,  Inc. 

AAFCO  FEED  INGREDIENT  DEFINITION  FOR  USE  OF  L- 
CARNITINE  IN  MILK  REPLACER  FOR  RUMINANTS  -  STUDY 
DESIGN 

2012-9042 

12/21/2012 
01/23/2013 

CVM/OCD/ 

Douglass  Oeller 

Douglass  Oeller  Consulting,  Inc. 

AAFCP  FEED  INGREDIENT  DEFINITION  FOR  THE  USE  OF 
CHROMIUM  PROPIONATE  IN  CATTLE  FEED  -  STUDY 
DESIGN 

2012-9043 

12/21/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1          1  /  1      \l    Vw/  |  V  1   1             If     \  '    L/    1            1       1/    \w/  III         /     1  '    1   L/   1  / 

JOSEPH  WALKER 

\J  V-/  V/  1— —  1     1   1    V  V  /  V  L_  1  V  1  1  1 

ARANESP - AERS 

ni  ini  "ii  \ji       i\i  i  ivj 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I—/  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Dow  Jones  &  Company 

2012-9044 

12/21/2012 

OC/OM/OCIO/ 

V-/  v_//  V_/  1 VI/  Vw/  Vw/  1  \*S/ 

INDIVIDUAL  RECS 

1  1  M  L/  1  V  1  1  f  V_/ 1  \  \       1  1 1_  V/  Vw/ 

01/23/2013 

FDA/OC/OES/DFOI/ 

Doe  J 

2012-9045 

12/26/2012 

1  C—l  £—  \Jl  t—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1    WLILL    I  Vw/  V/ £_ Vw-/  L/     1  V/ J 

MERCK  &  CO.,  INC. 

2012-7936  REQUEST  LETTER 

C—\J  \  C—     1  \J\J\J      1  ILuULU  1     1_ l_  1     1   1  1  I 

2012-9046 

12/26/2012 
01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   IVJVJLULf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-8010  REQUEST  LETTER 

C—\J  \  S—    \J\J  \  \J      1  l  1  vj<  V_/  1  1     1_ l__  1     1   1  1  I 

2012-9047 

12/26/2012 

1  C—l  C—  \JI  t—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1    WLILL    \  w  \-A  i—  V/  l_/      1  V/l 

MERCK  &  CO.,  INC. 

2012-7971  REQUEST  LETTER 

C—\J  \  C—     l  \J  l     I       11 V_x  Vw/  1— —  V/  1     1— 1__  1     1  l_  1  I 

2012-9048 

C—  \J    1  L—     v/  V/    1  V/ 

12/26/2012 

1  C—l  L—\Jl  C—\J\L— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl    1  VJV<lL.\/L/     1  V/ / 

MERCK  &  CO.,  INC. 

2012-7903  REQUEST  LETTER 

C—\J  \  C—   i              i  1 1—  v_x  Vw/ 1_ i    i_ i_  i   i  i  i  i 

2012-9049 

12/26/2012 

1  C—l  £_ \JI  C—\J\L— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  L-/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1    WLILL    IUV-IL.V/L/  / 

MERCK  &  CO.,  INC. 

2012-8034  REQUEST  LETTER 

C—\J  i  l     v/ w w  r    i  iL— vj(v/^v/  i    i—  i— _  i   i  i_ i  i 

2012-9050 

12/26/2012 

1  C—l  L—\Jl  t—\J\l— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    WLILl   IVJVJLULf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-8045  REQUEST  LETTER 

2012-9051 

12/26/2012 

1  C—l  L—  \Jl  C—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  L-/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

V/V/Cll  1    WLILL    \VJV/t-V/L/      1  V/ J 

MERCK  &  CO.,  INC. 

2012-8090  REQUEST  LETTER 

L—  V/  1  L       V/  W  ^  V/      11  L_  V_i<  Vw/  l_  V/  1     1— 1_  1     1  l__  1  I 

2012-9052 

t—\J    1  £-     v/  V/  V/  £— 

12/26/2012 

1  C—l  L—\Jl  C—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7085 

C—\J  1          /  V/V/v/ 

2012-9053 

12/26/2012 

1  C—l  C—  \Jl  t—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    L/  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1    WLILL    ^U>JLUI/  / 

MERCK  &  CO.,  INC. 

2012-8041  REQUEST  LETTER 

C—\J  \  C—    \-)  \J    l    1       1  ILuULU  1     1_  l_  1     1   1  1  I 

2012-9054 

12/26/2012 

1  t—l  i—  \JI  L —  V/    1  L — 

01/25/2013 

FDA/OC/OES/DFOI/ 

i  i— '  /  v  Vw/  v//  v.,/ 1_  V-//  i— /  i   VwX  i/ 

Joan  Stitt  (UG2CD-16} 

wWUI  1   Vw/  LI  I L    V  V/  Vwi  l —  V/  1 — '      \  \J  l 

MERCK  &  CO.,  INC. 

2012-8245  REQUEST  LETTER 

2012-9055 

12/26/2012 
01/25/2013 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16) 
MERCK  &  CO.,  INC. 

2012-8295  REQUEST  LETTER 

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2012-9056 

12/26/2012 
01/25/2013 

FDA/OC/OES/DFOI/ 

1  1— fi\l  V-/\J/  \Jl — \Jl  1— '  1  1/ 

Joan  Stitt  HJG2CD-161 

UVJO.II  w  LI  L  L  y  w      i_  w  L/    1  vj y 

MERCK  &  CO.,  INC. 

2012-8r?67  REOLJEST  LETTER 

t—  w  1  Cm   UUU  /       1  11  wU  1  w  1     1  1       1    1  1  1  1 

2012-9057 

L—\J    1  L—     \J\J\J  1 

12/26/2012 

1  t—l  C—  \Jl  L—  \J  1  t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1       l—fl\l    Vw/  Vw//   Vw/  1  \J/    1—/  1       VwX  I/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-8457  REQUEST  LETTER 

2012-9058 

12/26/2012 

1  t—l  C—\Jl  L—\J\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  11 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-8481  REQUEST  LETTER 

£_  w  1  s—    V/    i  V/  1       1  1 1  vj<  V_/  1  v_/  1     1_  l_  1     1   1  1  I 

2012-9059 

L—\J    1  L—  \J\J\J\J 

12/26/2012 

1  t—l  C—  \Jl  L—\J\L— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-8338  REQUEST  LETTER 

L—  w  1  L—    V/  W  W  V/      1  l^Vx  w  ^W  1     1_  l_  1     1  1_  1  I 

2012-9060 

12/26/2012 

1  t—l  L—\JI  L—\J\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— '  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 
MERCK  &  CO.,  INC. 

2012-8333  REQUEST  LETTER 

L—  W  1         V/  W*  v./  W      1  1 1_  V_/       l_  v_/  1     1_  l_  1     1   L_  1  I 

2012-9061 

L—\J    1  L—     \J\J\J  1 

12/26/2012 

1  t—l  C—  \Jl  t—\J\C— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  fUG2CD-16^ 

UUUl  1   WLIIL    IUV<Il.V/L/  / 

MERCK  &  CO.,  INC. 

2012-7476 

L—  W    1   t_      /       1^  /  V/ 

2012-9062 

t—\J   1  t—  \J\J\JL— 

12/26/2012 

1  t—l  C—\Jl  t—\J\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— '  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1   Willi    1  VJVJL.WL/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7066 

L_  W    1  t—      I  \J\J\J 

2012-9063 

12/26/2012 

1  t—l  C—  \Jl  L—\J\L— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  11 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-7065 

2012-9064 

12/26/2012 

1  t—l  t—\Ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— '  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16^ 

UUCll  1   Willi   IVJVJLV/Lf     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7058 

2012-9065 

L—\J    1  L—  \J\J\J\J 

12/26/2012 

1  t—l  t—  \ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-6664 

t—\J  \  t—    V/ V/ V/  i 

2012-9066 

t—\j  1  t—  \J\J\J\J 

12/26/2012 

1  t—l  t—\Ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— '  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

w  V/  Ci  1  1   Willi   1  VJV/L.WL/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-7566 

2012-9067 

L—\J    \  L—    \J\J\J  1 

12/26/2012 

1  t—l  t—  \Ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUUl  1   Willi    \  U  Wlt-WL/  / 

MERCK  &  CO.,  INC. 

2012-3744 

2012-9068 

12/26/2012 

1  t—l  t—\Ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/        1    Vw/  11 

Joan  Stitt  (UG2CD-16^ 

UUCll  1    Willi   1VJV/L.V/L/     1  \J  1 

MERCK  &  CO.,  INC. 

2012-8159 

L_  w  1  L    U  1  WW 

2012-9069 

L—\J    1  L—  \J\J\J\J 

12/26/2012 

1  t—l  t—  \Ji  t—\j\t— 

01/25/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

WV/Cll  1    Willi    1  UVJL.V/L/     1  \J  j 

MERCK  &  CO.,  INC. 

2012-7573 

l_  w  1  t_    /  w  /  w 

2012-9070 

12/26/2012 

1  t—l  t—\Ji  t—\j\t— 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— '  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUul  1    WLILl    1  VJVJL.V/L/     1  \J  1 

2012-5150 

L.U  1  i—    W  1  WW 

01/25/2013 

W    1  /  L —  W/  L —  W    1  W 

FDA/OC/OES/DFOI/ 

MERCK  &  CO.,  INC. 

2012-9071 

12/26/2012 
01/25/2013 

FDA/OC/OES/DFOI/ 

Joan  Stitt  (UG2CD-16) 
MERCK  &  CO.,  INC. 

2012-8360 

2012-9072 

12/26/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

Ed  Yoo 

PHELPS  INDUSTRIES  -  VIOLATIONS;  SANCTIONS 

Page  184  of  895 


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01/25/2013 

i— \  f~\  //"■»  i  1 1      n  / 

DO/GHI-GB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Corporate  Resolutions  Inc. 

(12/19/2002) 

2012-9073 

12/27/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Tim  Kelly 

K021062 

01/28/2013 

FDA/OC/OES/DFOI/ 

BIOLIFE 

2012-9074 

12/27/2012 

ORA/ 

Jen  Wieczner 

DRUG  RECALLS  -  LIST  BEFORE  CLASSIFICATION 

01/28/2013 

ORA/ 

ORA/OE/ 

ORA/OE/ 

FDA/OC/OES/DFOI/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      11  \J  \S  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OE/ 

ORA/OE/ 

Dow  Jones/MarketWatch 

2012-9075 

12/27/2012 
01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \w/  l_*/  1  1  1/  \-s  III    /  1  /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L_/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

finnan  Winnkur 

\—t  LJ  OCi  1  1    V  V  1 1  IUI\U  1 

Winokur,  Susan 

HI-TECH  PHARMACAL  -  BIOEQUIVALENCE  STUDY  AND 

III      1  1  \—J  III     II 1  \  1  1 1  V  1 1  \  Vw/ 1  \  1—        I  >  1  Vw/  1  vX  U  1  V  1  \  I— 1_  1  M  \w/  1— —   V/  1  \-J  1 — '    1     1  V 1  M  1_/ 

RATING  FOR  LEVOCARNITINE 

2012-9076 

12/27/2012 
01/28/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    VwX  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-8462 

2012-9077 

12/27/2012 
01/28/2013 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 

UUCll  1    WLILl   1  VJVJLV/Lf     1  \J  I 

MERCK  &  CO.,  INC. 

2012-8235 

£—  \J  1  £_  U£-V/v/ 

2012-9078 

12/27/2012 
01/28/2013 

FDA/OC/OES/DFOI/ 

1  1— '  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-16} 
MERCK  &  CO.,  INC. 

2012-8080 

2012-9079 

12/27/2012 

ORA/ 

Jeremy  Finley 

FOREIGN  OBJECTS  IN  FOOD  -  COMPLAINTS  IN  TENN 

01/28/2013 

ORA/ 

WSMV-TV 

2012-9080 

12/27/2012 
01/28/2013 

ORA/ 
ORA/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

Leslie  H.  Joyner  Esq. 
Marlin  &  Saltzman 

OH  SO  CLEAN,  CLEANWELL  PRODUCTS  -  CONSUMER 
COMPLAINTS  (10/25/2008  -  12/20/2012) 

2012-9081 

12/27/2012 
01/28/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

Sandy  Stagge 

CTI  Clinical  Trial  &  Consulting 

HILLARD  LAZARUS,  CINCINNATI,  OH  -  483,  CORR 
(08/01/1997-  10/29/1997) 

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Due  Date 

Services 

o  a  h  o  nnoo 
<i01  ^-yUO/i 

h  o  /o"7  /oa  h  o 

rUA/UoKUr/UriA/L/b-rU/L/IN- 

Sandy  Stagge 

1  IMI\/CDCITV  LinCDITAI    /"*AOC  IVflCrvlf^AI    PCMTCD  inn 

UNIVbribl  1  Y  nUorl  1  AL  OAbb  MbUIOAL  UbN  1  bhi  IHb, 

AH  /OO  /OA  H  O 
UlAiS/iiUI  O 

DO/CIN-CB/ 

Kj  i  \  oiimcai  i  rial  &  consulting 

CLEVELAND,  OH  -  483,  CORR  (1 1/30/201 1  -  01/31/2012) 

Services 

2012-9083 

12/27/2012 

FDA/OGROP/ORA/NE-FO/NYK- 

Richard  P.  Dickey,  MD,  PhD 

IVF  CLINICS  -  FDA  DISASTER  RESPONSE  INSPECTION 

01/28/2013 

UU/NYK-UUd/ 

The  Fertility  Institute  of  New 

r-)  r—  nAOTC  /HA /OH  /HO   HA /OA  OAHO\ 

KbKOK  I  b  (1 O/oO  20  \  2.) 

Orleans 

2012-9084 

12/27/2012 

FDA/OGROP/ORA/CE-FO/NWJ- 

Richard  P  Dickey,  MD,  PhD 

FDA  DISASTER  RESPONSE  INSPECTIONS  OF  IVF  CLINICS 

01/28/2013 

DO/NWJ-CB/ 

Fertility  Institute  of  New  Orleans 

(10/21/12-10/30/12) 

FDA/OGROP/ORA/CE-FO/PHI- 

UU/rnl-UbV 

FDA/OGROP/ORA/NE-FO/NWE- 

DO/NWE-CB/ 

IS  V*//  1  N  V  V  l_    Vw/ IS  I 

FDA/OGROP/ORA/NE-FO/NYK- 

1    IS  1  \l  \S  \-A  1   V  \S  1    /  \S  1   11  \I  1  >l  1— —    1    Vw/ /  1  X  1  1  \ 

DO/NYK-DCB/ 

2012-9085 

12/27/2012 

FDA/OF/CFSAN/OCD/EOS/ 

Leslie  H.  Joyner,  Esq. 

NONGSHIM  PRODUCTS  -  RECALLS,  INSPECTIONS, 

01/28/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

Marlin  &  Saltzman 

ADVERSE  EVENTS,  ETC  (12/19/2008  -  12/21/2012) 

DO/LOS-CB/ 

2012-9086 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Rowena  Dodaro 

VIVOTROL  -  8379054-6,  845351 1-6 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ALKERMES  INC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-9087 

12/27/2012 

FDA/OF/CFSAN/OCD/EOS/ 

I  pcijp  w  .Invnpr  F^n 

1 —  t7oMC7  1  1.  u  v  y  1  IUI  .  1 — ou  • 

DIET  7UP  -  RECALL  RECS  INSPECTION  RECS  AERS  ETC 

IS  1  l__  1      /   \s  1            1  1 1  \-s  J  \  1  1       1  1 1__  \  '  \J  ,    1  1  N  *S  1     1  \—S  1  1  \m/  1*1    11 1  •    /  V 1  1  I  Vw/  y    1       1  \s 

/OO  /OA  ^  O 

UHA/ 

Marlin  &  Saltzman 

(01/05/2009-  12/21/2012) 

ORA/ 

FDA/OGROP/ORA/CE-FO/CIN- 

DO/CIN-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 

DO/PHI-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 

DO/NYK-DCB/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

FDA/OGROP/ORA/PA-FO/SAN- 

DO/SAN-CB/ 

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Total  Records:  9990 


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Reed  Date  / 
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Signature/  Requester 

Subject 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

F  D  A/OG  ROP/O  RA/S  W-  FO/KAN- 
DO/KAN-CB/ 

2012-9088 

12/27/2012 
01/28/2013 

FDA/OC/OES/DFOI/ 

Johnathan  Rickman 
FDANEWS 

FOIA  LOG  (12/17/2012  -  12/21/2012) 

2012-9089 

12/27/2012 

FDA/OGROP/ORA/CE-FO/CHI- 

Kristina  Farmer 

MERIX  PHARMACEUTICAL,  BARRINGTON,  IL  -  ALL  RECS 

01/28/2013 

DO/CHI-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Segal  McCambridge  Singer  & 
Mahonpv 

ivicii  iui  i \j  y 

2012-9090 

12/27/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \s  III    /  1 — '  1  IS  1  / 

Mira  Parpkh 

1  v  1 1 1  d    1     CI  1  w  l\l  1 

LAMOTRIGINE  -  AERS 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  IS  1  1  1/        III    /  ( — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

UCSF  Medical  Center 

2012-9091 

12/27/2012 
01/28/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Evens  Augustin 
Evens  Augustin 

K1 22356,  K1 13514,  K1 10704 

2012-9092 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  V  1  1       1  /  \m/  L- /  1       1    1/  \-S  III     /  1 — f  I  l_/  I  / 

Mark  Mathipu 

Ivldl  l\   IVIC1LI  1  1  \^  \-A 

IND  DATA 

1  1  >l  IS    \S  1  \  1  t  \ 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

PAREXEL  International  Corp. 

2012-9093 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V^/  III    /  \ — '  1  IS  1  / 

Munial  fihpladia 

IVIUI  IJCll    \Jf  IvslClVJICl 

NDA  017010'  ANDA  072354  -  SUMMARY  BASIS  OF 

1  *J  IS  1  \  \J  1    /  \J  1  \J  ,   I  \  1  >l  IS  l  \  \J  1  C—  w  \J   l         \s  Vw/  1  V  1  1  VI/  VI  1  1     1  )  1  \ \S  1  Vw/   \s  1 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \  '  IS  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

PureTek  Corporation 

APPROVAL 

2012-9094 

12/28/2012 

FDA/OGROP/ORA/SE-FO/ATL- 

Yvonne  Higgins 

COPERNICUS  GROUP  IRB,  DURHAM,  NC  -  483,  EIR  (03/10) 

01/29/2013 

DO/ATL-CB/ 

COPERNICUS  GROUP  IRB 

2012-9095 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

Rennae  Lalwor 

XALERO  -  AERS  (01/01/2012  -  12/26/2012) 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Peninsula  Regional  Medical  Center 

Page  187  of  895 


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Total  Records:  9990 


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Subject 

2012-9096 

12/28/2012 
01/29/2013 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 
LaVeeta  Moten 

FUNDING  ALLOCATED  FOR  OMS  AWARDS;  AWARD 
PROCEDURES;  AWARD  CORRESPONDENCE,  ETC 
(01/01/2008-  12/20/2012) 

2012-9097 

12/28/2012 
01/29/2013 

FDA/OC/OES/DFOI/ 

LaVeeta  Moten 
LaVeeta  Moten 

INDIVIDUAL  RECS 

2012-9098 

12/28/2012 
01/29/2013 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 
LaVeeta  Moten 

REGULATION,  POLICY,  DIRECTIVE  RE:  SELECTION  OF 
STAFF  TO  REVIEW  RESUMES  FOR  GS-13  DETAILS  AND 
PROMOTIONS  WITHIN  OMS;  CORR  RE:  REVIEW  OF 
APPLICATIONS  OR  RESUMES 

2012-9099 

12/28/2012 
01/29/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \l  Vw/  1    /  w  1    *S  f\  1  VI/  \w/  Vw/  1 — /  /  l_  \S \JI 

[  oWppt?}  Mntpn 

l—CL  V  COICI    IVIUIDI  1 

LaVeeta  Moten 

CFSAN  BIRS  SYSTEM  -  USE  OR  CORR  RE  NON-USE 

W  1    *S  1  VI  *J    IS)  1  1  I  Vw/    U  1          1  1—  1 V  1         Vw/  Vw/  1        \S  1  I    Vw/  Vw /  1  1 1  I    11 1        1  VI  Vw/  1  V|         \S  1— 

(01/01/2008-  12/20/2012) 

2012-9100 

12/28/2012 
01/29/2013 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 
LaVeeta  Moten 

CFSAN  OSM  -  EMPLYEE  GRADE,  TITLE,  PROJECTS,  ETC 
(01/01/2008-  12/20/2012) 

2012-9101 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  IS  1  / 

AIpx  fiilvpr^tpin 

KALYDECO  -  AERS 

1  \l  V 1       1   IS  1  \S  Vw/        I  \  1  1  I  Vw/ 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SIGMA  CAPITAL  MANAGEMENT 
LLC 

2012-9102 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  \S  IS  1  1   If  W  III    /  I — '  1  L/  1  / 

AIpx  Silvpr^tpin 

I  \  \  \j  f\    *s  1 1  V  \j  1  OLvil  1 

BG-12  -  AERS 

IS  V — A        1   L               /   \  1        1    I  Vw/ 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SIGMA  CAPITAL  MANAGEMENT 
LLC 

2012-9103 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \w/  Lri/  1  1  1/  \-s  III    /  IS  1  J  /  1  / 

AIpx  fiilvpr^tpin 

XTANDI  -  AERS 

/  \  i  ni  X  \s  i      y  \  i  i  i  v_/ 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SIGMA  CAPITAL  MANAGEMENT 
LLC 

2012-9104 

12/28/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \-S  IS  1  1  1/  \S  III    /  \S  1  IS  1  / 

AIpx  fiilvpr^tpin 

I  \  \  \j  f\    *s  1 1  V  \j  1  OLvil  1 

KYPROLIS  -  AERS 

1    \      1       1           1       l  Vw/  1          1  Vw/                  /      \  1            1       l  Vw/ 

01/29/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SIGMA  CAPITAL  MANAGEMENT 
LLC 

2012-9105 

12/28/2012 
01/29/2013 

OC/OM/OMP/DDM/ 

JANNA  DEPORTER 

CENTER  FOR  SCIENCE  IN  THE 
PUBLIC  INTEREST 

DKT  &  DKT  LOG  OF  1999P-2630 

2012-9106 

12/31/2012 
01/30/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

Doe  J 

RHOGAM  -  VAERS  (01/20/2009  -  12/28/2012) 

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Control  # 

Reed  Date  / 
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2012-9107 

12/31/2012 

CVM/OCD/ 

V_/  V  1 VI/  v_/  V_/  La '/ 

Rarhpl  .lohnQon 

1  IQl^l   CI  UUI  II  IOUI  1 

POLYSORBATE  80  -  05/21/08  LETTER  FROM  CVM 

1     \s  \       1  <S\S  1  1 1  >  1  \  II       \J\J        \J\JI  L  llUU    1  1       1    II  111    1  I  Vw/  1 VI    \S  V  1 VI 

01/30/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

2012-9108 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

Johnathan  Rickman 
FDANEWS 

FOIA  LOG  (12/24/2012  -  12/28/2012) 

2012-9109 

L—\J    1   i—      \J    1  \J  \J 

12/31/2012 

1  t—l  \J    1  /  L—\J    \  L— 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1 \l  Vw/  1 V  1  1      1  /  \J  IS  1  1  1/  > — /  III    /  1 — '  1  IS  1  / 

EFUDEX  -  AERS 

i  i    \s>  i  '  i  /  \      /  v  i_  i  i 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2012-9110 

12/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

michael  reilly 

DMF  12053  (LYOJECT) 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  Lh'  1  1  1/  \w/  III    /  IS  1  L*/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

intpnritv  hio 

II  IL^y  1  ILV  Ul\J 

2012-91 1 1 

12/31/2012 
01/30/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L-/  1  11   1/  V_/  n^/  l__  1  1/  1 — /  1    Vw/  1/ 

Carl  O  Mannell 
Valmed,  S.A. 

1000  MUSCLE  STIMULATOR  SYSTEM  -  51  OK 

1  V/  V/  V/    1  V 1       Vw/  Vw/  1  1               1  1  1  V 1  \S  I  /  V  1  Vw/  1  I   *S  1          1  l__  1  V 1        v_y  1  V/  1  \ 

2012-9112 

12/31/2012 

FDA/OMPT/CDRH/OCER/DFOI/ 

Luk  Van  Hecke 

SYRINGE  PUMP  -  MAUDE  REPORTS  (01/01/2012  - 

01/30/2013 

TERUMO  EUROPE  NV 

12/27/2012} 

1  t—l  L—  1    1  C—\J    1   I—  J 

2012-91 13 

12/31/2012 

ORA/ 

Amandeep  Singh 

SAMPLE  RESULTS 

01/30/2013 

ORA/ 

RiaFragrancelncDBANaturalHoneyl 
mporters 

2012-91 14 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  \w/  L-/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

Samupl  (Graham 

UQI  1    LHj     \^  1  Ql  Id!  1  1 

NDA  21446  S010 

1  *■  IS  I  \  L—  \           V/              1  V/ 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  v  1  1          11   \  '  Lh'  1  1     1/   \w/  III       /    1  '   1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

University  of  Wisconsin-Milwaukee 

2012-91 15 

12/31/2012 

1  t—l  \J  1  /  t—\J  1  L 

01/30/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

i  i  \  \s  i  1 1  i  n  v_j  i  1 1  \  i  1 1  i 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  11/5-9/12 

1    Vw/ 1    lw/  /  VI  1       1     LW  VI     1    11  \J    \J1    1  L— 

2012-91 16 

12/31/2012 

1  t—l  \J  1  /  t—\J  \  C— 

01/30/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

1—1 V \S)  1  1 1__  1  N    \S    *S  1 \  1  I  1  l 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  11/12-16/12 

1    Vw/ 1    l_/  /  VI  1       1     LvV/     1    1  /   1  C—      IV//  1 

2012-91 17 

L_  v/   1  £_    ^/   1     1  / 

12/31/2012 

1  t—l  \J  1  /  L—\J  1  L 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    L>  / V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    Vw/  1/ 

LAUREN  S  BARR 

i  i  \  *s  i  1 1__  i  n  *s  is  i  \  i  ii  i 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  12-3-7-12 

1    Vw/ 1    \S  1  \  1  L_  1     L\/ vl     1  L_    \J    1       1  L_ 

2012-9118 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

LISA  TARISON-SCHRAMP 
CanReg,  Inc. 

FOI  DAILY  LOG  12/3-7/12 

2012-9119 

12/31/2012 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 

FOI  DAILY  LOG  11/26-30/12 

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CanReg,  Inc. 

2012-9120 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  12/3-7/12 

2012-9121 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  11/26-30/12 

2012-9122 

12/31/2012 

1  t—l  \J  1  /  t—\J  1  £— 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    VwX  1/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  12/3-7/12 

1    Vw/  1    l_/ 1  \  1  1       1     1  Vw/           1  L/vJ     /  /    1  t— 

2012-9123 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  11/26-30/12 

2012-9124 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  12/3-7/12 

2012-9125 

12/31/2012 
01/30/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

FOI  DAILY  LOG  11/26-30/12 

2012-9126 

12/31/2012 

1  t—l  \J  1  /  t—\J  \  t— 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  L-f  1    Vw/  1/ 

GLADYS  B  TONKIN 

V_^  1  I  \  \—s   1  \J  I— J     1  Vw/  1  *l  1  V  1  1  N 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  11/26-30/12 

1    Vw/  1    ]—//  VI  1       1     1  V_/  k^A     1    1  /  t—  \J    \J  \Jl    1  C— 

2012-9127 

12/31/2012 

1  t—l  \J  \  1  L—\J  1  L 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

V/  1  1  \  \—J    1   \J    E  >      1   V_/  1  >l  1  \  1  1  N 

Center  for  Regulatory  Services,  Inc. 

FOI  DAILY  LOG  12/3-7/12 

1    Vw/  1    lw/  /  VI  1       1     L_  Vw/  V^l     1  t—  I  \j     1  I  1 

2012-9128 

12/31/2012 

1  t—l  \J  \  1  t—\J  1  t— 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  L-f  1    Vw/  1/ 

BARBARA  JONES 

1  >  1      \  1       l  1  '  I      \  1       1  I      \      \J  Vw/  1    1|   1   Vw/ 

DOMINION  GROUP  INC 

FOI  DAILY  LOG  11/26-30/12 

1    Vw/  1    ]—//  VI  1       1     1  V_/  K^A     1    1  /  t—  \J    \J  \Jl    1  C— 

2012-9129 

12/31/2012 

1  t—l  \j  1  /  t—\j  I  t— 

01/30/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/        1    Vw/  1/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

FOI  DAILY  LOG  12/3-7/12 

1    Vw/ 1    L>  1  \  1 1       1     l_V/V/     1  t—l  vJ     /  /    1  £_ 

2012-9130 

L—  V/    1  £_     v/    1  \_J  W 

12/31/2012 

1  t—l  \J  1  /  t—  \J  It— 

01/30/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \h/  Lp/  1  11   1/  V_/  V^/  l_  1  1/  1 — /  1    Vw/  1/ 

L  LEE  HICKS  II 

1      1  1  1       1  1  1  V/  1  \  w  II 

MOORE  &  HICKS  PC 

ENCORE  ORTHOPEDICS  INC  -  TIBIAL  INSERT  K963028 

1  1  MV/V/I   ll        Vw/  1  1  1  1   1  Vw/  1     1  1  '  1  V_/  V_J    II  »V/          1  lUini       1 1  M  VJ  1  1  1  1     1  \JUvUl.U 

2012-9131 

12/31/2012 

1  t—l  \j  1  /  t—\j  I  t— 

01/30/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

L  LEE  HICKS  II 

1        1  1  1         1    l|V_/|\i_J  II 

MOORE  &  HICKS  PC 

ENCORE  ORTHOPEDICS  INC  -  FOUNDATION  KNEE  SYS 

1  1  N  V-/  Vw/  1  1 1        Vw/  1  1  1  1   1  Vw/  1     1  1  '  1  \J\J    1 1  M  \J        1    Vw/  W  1  VI 1  '  1  \  1  1  Vw/ 1  N    1  \  l  M  1  1        Vj  1  O 

TIBIAL  COMPONENT  K970031 

2012-9132 

12/31/2012 
01/30/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JULIE  VAFIDES 
DEPUY  MITEK 

DEPUY  MITEK  -  INTRAFIX  TAPERED  SCREW 
(INTRATUNNEL  FIXATION  FASTENER)  K983560 

2012-9133 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ABILIFY  -  AERS 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ROTH,  GAIL  P 

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FDA/OMPT/CDER/ORP/DIDP/ 

2012-9134 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

DAVID  C  WEBER 

ROXANE  LABS  -  PREDNISONE  CITIZEN  PETITIONS,  PI, 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BEHREND  ERNSBEERGER,  PC 

MCniPAl     \C\\  IDMAI    PDTC  HQQQ  TC\  DPCCCMT 

IVItUIUAL  JUUriNAL  rtr  1  o  \  yyy  1  vj  rntotN  1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OM/OMP/DODM/ 

2012-9135 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ELAVIL  -  AERS 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

HELEY  56354-112,  FRANK 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2012-9136 

12/31/2012 

FDA/OMPT/CDER/ORP/DIDP/ 

ELAINE  S  WALLER 

ADCETRIC  (BRENTUXIMAB  VEDOTIN)  -  AERS  3/1/12  TO 

01/30/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

SEATTLE  GENETICS  INC 

11/30/12 

FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UMr  I  /L/Utrl/Urir/UIUrV 

2012-9137 

12/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

LISA  Y  LEFFERTS 

BROMINATED  VEGETABLE  OIL  -  TOXICOLOGICAL  STUDIES, 

AH  /OA/OAH  O 

01/30/<;01o 

GbN  I  tK  rUK  bGlbNGb  IN 

TOXICITY  CORR,  AERS  1/70  TO  PRESENT 

□  1  IDI  I/"1  IMTCDCCT 

rUbLIU  IN  1  bribb  1 

O  A  H  O  (HOO 

^012-9138 

4/\/fH  /OA  H  O 

rUA/Ur/OrbAN/UGD/bUb/ 

A  A  |  f\  1 —  |    a  Olk/IX/TLJ 

ANubLA  bMY  1  H 

^  a  n  [—  o  hca/iaa     AnniTiAMfti    n  [—  o 

OAKbb  159466  -  AUDI  I  IUNAL  KbOb 

AH  /O.A/OAH  O 

IUVA  1  b  nbAL  1  n  bL-lbNobb 

1  MTC  DM  A  "Tl/^M  A  1  IMO 

IN  1  bKNA  1 IUNAL  INO 

2012-9139 

12/31/2012 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

CAERS  159466  -  ADDITIONAL  RECS 

01/30/2013 

IOVATE  HEALTH  SCIENCES 

IMTCDMATIAMfll  IMP 

IN  1  briNA  1  IUNAL  INL. 

O  A  H  O  H 

^01  o-1 

AH  /AO /OA H  O 
Ul/U/i/^UI  O 

rUA/UuHUr/UnA/rA-rU/LUo- 

JbNNIrbri  GUNNbri 

nnm  flr  ADTUADCniPO  IMP    DDIIV/IC  IV  VI C n IP  A  1     DLOPI  IDpLO 

rKIMb  UK  I  HUrbUIGb  INO,  rrilMb  MbUIUAL  KbbUUKL/bb  - 

01/31/2013 

\J  l  1  \J  11  L—\J  1  \J 

DO/LOS-CB/ 

AMERICAN  CLAIMS 

I  \  1  v  1 1  1  1 1  > — /  /  \  1  *J  Vw /  1  t  \  1 1  v  1  U 

483S,  MDRS,  ESTABLISHMENT  REGISTRATION,  ETC 

FDA/OGROP/ORA/PA-FO/SAN- 

MANAGEMENT 

DO/SAN-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2013-2 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

LOUIS  S  FRANECKE 

ST  JUDE  MEDICAL  -  RIATA,  RIATA  ST  DEFIBRILLATION 

01/31/2013 

OM/OMP/DODM/ 

FRANECKE  LAW  GROUP 

P950022/S006,S007,S008,  ETC  EIRS,  483S,  RPTS,  ETC 

FDA/OC/OES/DFOI/ 

2013-3 

01/02/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

GM  MANUFACTURING  INC,  GARDENA,  CA  -  483S  1/23/12- 

01/31/2013 

DO/LOS-CB/ 

Meade,  Doris 

2/13/12 

2013-4 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

RANDY  SCHERER  PHD 

MERIT  MEDICAL  INC  -  EMBOSPHERE  MICROSPHERES 

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Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


01/31/2013 

Cook  Medical 

INVESTIGATIONAL  DVC  EXEMPTION  (IDE)  APRVL  LTR, 

PHASE  III  CLNCL  STUDY  PROTOCOL 

2013-5 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

MEDTRONIC  -  INSULIN  PUMP  P980022  RECS 

01/31/2013 

HENSON,  JOHN.  D 

2013-6 

01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

BETH  CLAY 

DIETARY  SUPPLEMENTS  -  FDA  REGISTRY  DATA 

01/31/2013 

CAPITOL  STRATEGY 

CONSULTANTS 

2013-7 

01/02/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 

ALYSON  OLIVER 

PHARMACEUTICAL  INNOVATIONS  INC  -  ULTRA  PHONIC 

01/31/2013 

DO/NWJ-CB/ 

OLIVER  LAW  GROUP 

CONDUCTIVITY  GEL,  SONIC  GENERIC  ULTRASOUND 

FDA/OMPT/CDER/ORP/DIDP/ 

TD AMCMICCIOM  f^iCI     1  II  TPA  DUir^MIO  CHMTAMCI  1  C 
1  nANolvlloolvJN  citL,  UL  1  HA  rMUNIU  rUN  1  ANtLLt 

SCANNING  PAD,  ETC  INSP,  LBLG,  STERILIZATION,  ETC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

UM/UMr/UULJM/ 

FDA/OGROP/ORA/GE-FO/NWJ- 

DO/NWJ-CB/ 

2013-8 

01/02/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

ALYSON  OLIVER 

MEDTRONIC  -  MOSAIC  PROCINE  BIOPROSTHETIC  HEART 

01/31/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

OLIVER  LAW  GROUP 

VALVE  PMA,  RVWS,  PROCEDURE  MANUALS,  ETC 

DO/LOS-CB/ 

2013-9 

01/02/2013 

FDA/OGROP/ORA/SE-FO/NOL- 

DOUGLAS  N  BLUE  II 

BEINING  NOVARTIS  PHARMA  CO  LTD  -  COARTEM  120  MG 

01/31/2013 

UU/  IMUL-UD/ 

ZETETIC 

2013-10 

01/02/2013 

FDA/OGROP/ORA/SE-FO/FLA- 

DONALD  N  BLUE  II 

AV300384441  -  RECS 

01/31/2013 

DO/FLA-CB/ 

ZETETIC 

2013-11 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

KATY  MORTON 

KATAYAMA  SEIYAKUSHYO  CO  LTD,  TOYAMA,  JAPAN  - 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

TOPICA  PHARMACEUTICALS  INC 

tlno,  4ooo,  VVAnNMNVji  L  I  no,  1 1  O  1/U4  I  U  rntotlN  I 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-12 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

WILLIAM  BRENNAN 

COVIDIEN  -  ONYX  LIQUID  EMBOLIC  SYS  (ONYX  HD-500) 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

SEDGWICK  LLP 

AERS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

2013-13 

01/02/2013 

FDA/OF/CFSAN/OCD/EOS/ 

CHRISTIE  L  GARZA 

FDA  RETAIL  AND  FOOD  SERVICE  HACCP,  FDA  SEAFOOD 

01/31/2013 

ARMANDO  DE  DIEGO  PC 

HACCP  5/03  (CERTIFIED) 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
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Action  Office 

Signature/  Requester 

Subject 

2013-14 

01/02/2013 
01/31/2013 

\J  1  /  \J  1  /  t—\J  I  \J 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      11  \J  \—J  1  1  1/  \-s  III    /  I — '  1  \—J  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
CVM/OCD/ 

KATY  MORTON 

TOPICA  PHARMACEUTICALS  INC 

1  v_/  1     1  \S  1  \    1     1   1 1  \  1  1 1  V  1 1  \  \S  \  KJ  1  1  V/ 1  \  L_  O    1  1  >l  \S 

KATAYAMA  SEIYAKUSHYO  CO  LTD,  OSAKA,  JAPAN  -  EIRS, 
483S,  WARNING  LTRS,  ETC  1/04  TO  PRESENT 

2013-15 

01/02/2013 

\J    1  /  \J  L—l  L.U    1  U 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      11  \S  IS  1  1  1/  W  III    /  I — '  1  IS  1  / 

ACTOS  METFORMIN  PIOGLITAZONE  -  RECS 

/  \  Vw/  1  Vw/  Vw/  .    1 V  1  1— —  1  1    Vw/  1  II VI  1  1  v  ^    1     1  V_/  K-A  I  1  1  1  \  L  \s  1  N  1             1  1 1_  V/  V— ' 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

KARRAS,  EDWARD 

2013-16 

01/02/2013 
01/31/2013 

F  D  A/OG  ROP/O  RA/S  W-  FO/D  AL- 
DO/DAL-CB/ 

ORA/OCI/ 

ORA/OCI/ 

Anderson,  Carl 

DANIEL  LANSDOWN,  PURE  PEPTIDES,  HOUSTON,  TX  - 
ANABOLIC  STEROIDS,  HUMAN  GROWTH  HORMONE  CORR 
1/10  TO  PRESENT 

2013-17 

01/02/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

RUTH  RIZKALLA  ESQ 

RHBMP-2  -  BIOLOGICS,  DRUG  LICENSE  APPL 

01/31/2013 

ALFB/ 

SIZEMORE  LAW  FIRM  PLC 

2013-18 

01/02/2013 

U  l/U  L—l  C—\J  I  o 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \w/  1  v  1  1      1  /  \m/  L- /  1  1  1/  V_/  III    /  \S  1  1—/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ANDREWS  D1 7561,  JOHN 

MORTON  GROVE  -  SELENIUM  SULFIDE  LOTION'  PERRIGO 

1 V  1  Vw/  1  1  1  Vw/  1  >l    \-A  1  1  V_/  V  1— —              1  l_  l_  1  *J  1  V/  1 V  1    V*J  V/  1—  1     1  IS  \        L_  V_/  |   |  Vw/  1  >l  ^    1     1  1  II  II  \s\  Vw/ 

-  SELENIUM  SULFIDE  TOPICAL  SOL  RECALL  RECS 

2013-19 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      11  \S  IS  1  1  1/  W  III    /  L*/  1  1  /  1  / 

Tina  Rahn^ 

1  II  Id  1 — ' Cl uuo 

ANDA  202608  -  APPROVAL  LETTER 

1  \  1  M  IS  I  \  L—\JC—\J\J\J        1  V 1     1     1  I  \s  V  1  \  1—   1—  1       1    1  l_  1  I 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

IPD  ANALYTICS  LLC 

2013-20 

01/02/2013 

\J  1  /  \J  L—l  L—\J\\J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \S  IS  \  1  1/  W  III    /  (_/  1  l_/  1  / 

David  1  in 

IS  Cl  V  1 U  ^111 

NDA  202292  -  APPROVAL  PACKAGE 

1  *J  \S  1  \  L—  V/  £_  L—      L_        /  V 1     1     1  I  Vw/  V  /  V 1       1    /  \  V/  1  \/\  Vwi  1  

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BIOLOGICS  CONSULTING 
GROUP 

2013-21 

01/02/2013 

\J  1  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  \J  IS  \  1  1/  W  III    /  I — ^  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

fifpnhpn  R  Autpn 

OLUUI  \\jt  1    1  I.    1  \  LUUI  1 

COZEN  O'CONNOR 

ANDA  202093  -  FILING  RECEIPT  CORR  PATENT 

/  VI  N  IS  1  \  Cm\J  C—\J  \J\J        1     1  ^—  1  1  il  \s\    1  1 1_  \S  l_  II      1   .    \S  Vw/  1  1 1  1 ,    1     /  \  1  1  1  >J  1 

CERTIFICATIONS  ETC 

2013-22 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

RONALD  A.  MARRON 

LAW  OFFICES  OF  RONALD  A 
MARRON 

UNDREDACTED  RECS 

Page  193  of  895 


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Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2013-23 

01/02/2013 

\J  1  /  \JL—I  L-\J  1  O 

ORA/ORM/ 

JOHNATHAN  RICKMAN 

\J  V_/  1   IIM/^  1  1   mi  M    1  I 1  \J  1  \l  Vl/^l  N 

ALL  NOTICES  TO  PHARMACEUTICALS  -  483'S  11/12 

1  \  1  1      1  *■  Vw/  1  1  \J  1  vJ     1  Vw/   1    1  1  f\  1  11  V 1 1  \  Vw/  1  V/  1  1  v_//\  1  vJ       "  VJ  i_>  t  '    1    1  /  1  £_ 

01/31/2013 

ORA/ORM/ 

FDA  NEWS 

2013-24 

01/02/2013 
01/31/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

SINEAD  O'DONOGHUE 
GLOOR  LAW  GROUP  LLC 

ROLFS  PATISSERIE,  LINCOLNWOOD,  IL  -  S  AUREUS 
OUTBREAK  SINCE  11/2/10 

2013-25 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  1  \l  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

A  LUKE  SMITH 

1  \  i    1  KJ  1  \  1—         1  V 1  1  1  1  1 

RANBAXY  BATAMANDI  -  EIR  3/08 

1  VI  VI  N  I  >  1  \/\  1   ,    1—}  1  \  1  /  VI V  1 1  \ 1  VI  J  /  1         1  II  I   \JI  \J\J 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FARUQI  &  FARUQI  LLP 

2013-26 

01/02/2013 
01/31/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

REZA  TORKZADEH 
TORKZADEH  LAW  FIRM 

OH  A  A  nACAAOO 

PMA  P950022 

2013-27 

01/02/2013 

FDA/OMPT/CBER/OOOD/DDOM/ 

JOHN  CREWDSON 

MERCK  -  ZOSTAVEX  SHINGLES  PATIENTS 

01/31/2013 

ALFB/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

2013-28 

01/02/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

KIMBERLY  D  ERNST 

1  \  1  1  V 1  I  >  1  11^1      L/  ■    l_  1  1 1  VI  \J  1 

SANOFI  -  DIABETA  NDA  17-532  SBA 

V/  /  VI  M  Vw/  1    1         L/  1  /  V 1  '  l_  1  /  V   1  N  1 — '  1  \     1  /     v/  V-/ 1_  L//1 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/ 1  v  1 1      1  /  v/  l_/  1  1  1/  W  III    /  (_/  1 1_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

COREPHARMA  LLC 

2013-29 

01/02/2013 

\J  1  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 

1    L/  /  V/  Vw/  V_^  1  1  Vw/  1    /  Vw/  1  It \/  V/  l_    1    Vw//  M  VVU 

DO/NWJ-CB/ 

VICTORIA  SCOTT 

V    1  Vw/    1    Vw/  1     1  1  / \     Vw/  Vw/  Vw/    i  i 

HEMISPHERX  BIOPHARMA 

HEMISPHERX  BIOPHARMA  INC  NEW  BRUNSWICK  NJ  - 

1   1  1  1 V  1  J  U  1     1   1  1  1   1  /  V    1  '  1  Vw/  1     1   If  VI  1 1 V  1  /  V    1  1  VI  V/  „    1  VI  l__  V  V    I  >  1  1  V_/  1  VI  Vw/  V  V  1  Vw/  1  \  H  1 

INSP  CORR  10/12,  11/12 

2013-30 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

REO  TANOSHIMA,  MD 
HOSPITAL  FOR  SICK  CHILDREN 

KEPPRA- AER 

2013-31 

01/02/2013 

\J    1  /  \J  L—l  L.U    1  U 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  (_/  1  ]  /  1  / 

SEROOUEL  -  AER  2000  TO  2008 

Vw/  E  1   IV/Vj(  Vw /  1  L_        1  \  1  1  I   L_  V/  W  V/     1  V_/    L  \J\J\J 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SPENCER  D29593,  NATHAN 

2013-32 

01/02/2013 

\J  1  /  \J  L—l  L—\J\\J 

FDA/OMPT/CDER/ORP/DIDP/ 

i  I — '  /  v/  Vw/ 1  v  1 1     i  /  Vw /  l*s  i  i  i/  v_/  iii   /  (_/  i  j  /  i  / 

CANNABINOIDS  -  APRVL  RPT 

v_/  /  vi  v  i      \  i  / 1 1  vi  Vw/ 1 L/  v_/      y  \  i    i  i  v  l  in  i 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

THOMAS  T67081 ,  KEITH 

2013-33 

01/02/2013 

\J    1  /  \J  L—l  L —  \J    1  \_/ 

FDA/OMPT/CDER/ORP/DIDP/ 

EFFEXOR  -  AER 

01/31/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HENLEY  56354  112,  FRANK 

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Total  Records:  9990 


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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2013-34 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

1  1— fi\l  V-/\_//  \Jl — \JI  1— '  1  II 

Mpnpn  Pipkpl 

ivicuai  I  I  Hj|\ci 

BEVERIDGE  &  DIAMOND 

CFSAN  FOIA  REOUESTS  (12/01/2012  -  01/02/20131 

W  1     Vjf\l  N     1     V-/  1 1   \    A   \  A  «o(  V- 1  1  Vj   1  \J       \    A  L—l  \J   A  /  L—\J   A  L—         \J   \  1  KJ  L—l  L—\J   1  U  I 

2013-35 

01/02/2013 

\J  A  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OC/OES/DFOI/ 

1       l—fl\l    Vw/  Vw//   Vw/  |  \J/    1—/  |       VwX  1/ 

Joan  Stitt  (UG2CD-161 

UUUl  1   WLIIL    IUV<luV/L/  / 

MERCK  &  CO.,  INC. 

LIST  OF  CLOSED  FOIA  REOUESTS  M/1/2012  -  12/31/20121 

1  1  \—f  l     V_/  1      Vw/ 1_ Vw/  Vw/  l_  l—/    1    V_/  1 1  \   A  1  1  VX  \J  1  \—}  A  U    \    1  /    A  1  C—  \J  A  L—          A  L—l  \J  A  I  L—  \J  A  L—  1 

2013-36 

L—\J    I  \J  \J\J 

01/02/2013 

\J  A  /  \J  L—l  L—\J\\-t 

01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-161 
MERCK  &  CO.,  INC. 

LIST  OF  CLOSED  FOIA  REQUESTS  f1 2/1/1 2-1 2/31/1 21 

L—  A  V  J     Vw/  1      Vw/  LV/U  l_  l_/    1    Vw/  1  /  V   1  1  1  vX  Vw^  1  v_J  1  U    l    1  L—l    At    A  L—      \  L—l  \J  A  I    \  L—  J 

2013-37 

01/02/2013 

\J  A  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Joan  Stitt  (UG2CD-161 
MERCK  &  CO.,  INC. 

FOI  DAILY  LOG  M  2/1/1 2-1 2/31/201 21 

1    Vw/  1    lw/ /  VI  1       1     LV/  vi      1    1  L—l    A  I    I  L—     I  L—l  Kj  I  1  L—\J  I  L—  J 

2013-38 

L—\J    I  \J  \J\J 

01/02/2013 

\J  A  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

Vw4  l—l    \  \—S      A     \J      l—l  m         A    Vw/  |   N  1   V  1  1  *l 

Center  for  Regulatory  Services,  Inc. 

DAILY  LOG  12/10-14/12 

\—r  1   \  I  L_   1      1  \w/             1  L—l    \  \J      \            1  L— 

2013-39 

L—\J    1  \J  \J\J 

01/02/2013 

\J    A  /  \J  L—l  L.U    1  U 

01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

V_/  l—l    \  \—J      A     \J      l—l  m         A    Vw/  |    *J  |    V  1  1  N 

Center  for  Regulatory  Services,  Inc. 

DAILY  LOG  12/17-21/12 

l—f  1   \  1  1       1      1  V*/  V_^1      1            1    /      L—   1  1    I  L— 

2013-40 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

FOI  Services,  Inc. 

DAILY  LOG  12/17-21/12 

l—/ 1    \  1  1         1       l_  Vw/  Vwl       1  £-/     1    /                1  /     1  L— 

2013-41 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

DAILY  LOG  12/10-12/12 

2013-42 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

DEBRA  L  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  12/10-14/12 

2013-43 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

DEBRA  L.  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

DAILY  LOG  12/17-21/12 

2013-44 

01/02/2013 

\J  A  /  \J  L—l  L—\J\\J 

01/31/2013 

FDA/OC/OES/DFOI/ 

1    l—fi\l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  11 

BARBARA  JONES 

\—t  1      \  l       l  l  I  1      \  \       \  1      \      \J  Vw/  I     *J    1   \_) 

DOMINION  GROUP  INC 

DAILY  LOG  12/10-14/12 

1—/I  V 1  L_  1     I  V_/  V^     1  L—l    \  \J      \           1  £_ 

2013-45 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

DAILY  LOG  12/17-21/12 

2013-46 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

KENNETH  REID 

WASHINGTON  INFORMATION 
SOURCE 

DAILY  LOG  12/10-14/12 

2013-47 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

KENNETH  REID 

WASHINGTON  INFORMATION 
SOURCE 

DAILY  LOG  12/17-21/12 

2013-48 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

DAILY  LOG  12/17-21/12 

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/"V  1  1  It 

Control  # 

Reed  Date  / 
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Signature/  Requester 

Subject 

2013-49 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

DAILY  LOG  12/10-14/12 

\—t  I  \  \  L     i    i_v_/\wJ    i  C—l  \  \j    \  *~r/  I  L— 

2013-50 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

L—l    \  \—J  1    1 1— —  1  V|     Vw/  ■     1  '  /    \  1    1 1  I 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  12/10-14/12 

\—r  1   \  \  L—   1      1  \_^/             1  L—l    \  \J      1            1  L— 

2013-51 

01/02/2013 
01/31/2013 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

l—l     \  Vw/  1     l  1— —  1    *J      Vw/  ■      1—/1 \  1     l  1  l 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  12/17-21/12 

1  /  /   \  1  1        1      l_  Vw/  \-A      1  L—l    \    I      L—   \  I    \  L— 

2013-52 

01/03/2013 
02/01/2013 

OC/OM/OMP/DDIW 

Vw /  Vw//  Vw/  1  V  1/  Vw/  |  V  1  1       /    1  /  (_/  1  V  1/ 

MINDY  B  DUANE 

1  V  1  1  1  *J  I — /   1  I— J -    L*s  Vw/  / \  1  >|  1  

INFOTECH  DATA  RESEARCH 

DKT  FDA-  1995-S-0039 

2013-53 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LAUREN  S  BARR 

l—l \  Vw/  1     l  1— —  1    *J      Vw/      1  '  i \  \      ii  i 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REQUESTS  12/17-21/12 

Vw/ 1— Vw/  Vw/  1  1  J     1      Vw/  1  /    \     1    1  1— —          Vw/  1  U    1    U       1  L—l     1    /               1  /     1  L— 

2013-54 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

DAVID  MCFARLAND 

1  J  1 \  V  1  1  /    1  v  1  Vw*  1    / x  1  1 1  /  \  1  *l  1 — / 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  12/17-21/12 

Vw/  l—  Vw/  Vw/  1            (_/        |         Vw/   1  /      \        1       1  1— —  \J   Vw/    1           Vw/      1      Vw/           1     ^/        1       /           L_      |    /        |  L— 

2013-55 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

LISA  TARISON-SCHRAMP 
CanReg,  Inc. 

CLOSED  FOIA  REQUESTS  12/17-21/12 

V/LV/W  1  1  '    \    Vw/  1  /  \    1  1 1— —  V_rf  Vw/  1  U  1  U     1  L_/    1  /           1  /    1  L— 

2013-56 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

CLOSED  FOIA  REQUESTS12/17-21./12 

2013-57 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOIA  REQUESTS  12/17-21/12 

2013-58 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

GLADYS  B  TONKIN 

Vwl  l—l  \  l—J    1   U    I  >      1   V_/  1  VI  1  \  1  1  N 

Center  for  Regulatory  Services,  Inc. 

CLOSED  FOIA  REQUESTS  11/26-30/12 

Vw/ 1—  Vw/  Vw/ 1  iw/  i   Vw/  i  /  v  i  1 1__  \j  Vw^  t  u  i  u    i  it  L—  v/  v/  V//  i  L— 

2013-59 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

GLADYS  B  TONKIN 

Center  for  Regulatory  Services,  Inc. 

CLOSED  FOIA  REQUESTS  12/3-7/12 

2013-60 

01/03/2013 
02/01/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

1— /  V  '     |     l—l \    \_J  !  1 

FDA/OC/OES/DFOI/ 

BRENDA  M GARTZ 
ELI  LILLY  &  CO 

CARDINAL  HEALTH,  ORLANDO,  FL  -  EIR  3/1 1 

2013-61 

01/03/2013 
02/01/2013 

v/  L—l  v/  1  /  L —  \J  1  \-> 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

HOSPIRA,  MCPHERSON,  KS  -  EIR  1/12,  5/12 

2013-62 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 

MUSTAFA  NEVZAT,  YENIBONSNA,  TURKEY  -  EIR  4/12 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

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Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-63 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 

MUTSAFA  NEVZAT  LLAC  SANAYII,  ISTANBUL,  TURKEY  -  EIR 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

11/10 

2013-64 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 

NORBROOK  LABS,  NEWRY,  GB  -  EIR  4/12 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
CVM/OCD/ 

ELI  LILLY  &  CO 

2013-65 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 

ORION  CORP,  ESPOO,  FINLAND  -  EIR  6/1 1 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2013-66 

01/03/2013 
02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MAE  WU 

NATURAL  RESOURCES 
DEFENSE  COUNCIL 

COLGATE-PALMOLIVE  -  NDA  02-0231  RVWS, 
PHARMACOLOGY,  TOXICOLOGY  RECS 

2013-67 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

KATE  PURCELL 

IMPAX  -  AN  DA  76-298  APRVL  LTR 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DOCUTRIEVAL  INFORMATION 
SERVICES 

2013-68 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

AVANDIA  -  AERS 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CASSELLS,  KEITH 

2013-69 

01/03/2013 
02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OF/CFSAN/OCD/EOS/ 

SEAN  HIGGINS 
ANDREWS  THORNTON 

JACK3D,  OXYELITE  PRO,  NUTREX  LIPO-6  BLACK  PRODS, 
ETC  -  AERS  5/12  TO  PRESENT 

2013-70 

01/03/2013 
02/01/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

JOHN  CREWDSON 
PROJECT  ON  GOVERNMENT 

MERCK  SHARP  &  DOHME  -  ZOSTAVAX  NDA  12-5123 
ANNUAL  RPTS  12/30/09,  6/18/12 

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Signature/  Requester 

Subject 

OVERSIGHT 

2013-71 

01/03/2013 
02/01/2013 

FDA/OF/CFSAN/OCD/EOS/ 

OC/COS/OES/ 

OC/COS/OES/ 

SHANNA  DEVINE 

GOVERNMENT 
ACCOUNTABILITY  PROJECT 

CRUDE  OIL,  COREXIT  9500,  COREXIT  9527  -  TRANS, 
INTERVIEWS,  STATEMENTS,  ETC  4/20/10  TO  1/26/12 

2013-72 

01/03/2013 
02/01/2013 

FDA/OC/OES/DFOI/ 

YOIRA  FERNANDEZ 

FREIDIN  DORBRINSKY  ATTY  AT 
LAW 

2012-6312  (CERTIFIED) 

2013-73 

01/03/2013 

ORA/ 

CMPLNT 

02/01/2013 

ORA/ 

Doe  J 

2013-74 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

NDA  202379  S5 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2013-75 

01/03/2013 
02/01/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

RICHARD  O  DEROBERTS 
DEROBERTS,  RICHARD  O 

K111501 

2013-76 

01/03/2013 
02/01/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Rachel  Nosowsky 
UNIVERSITY  OF  CALIFORNIA 

COLUMBIA  PRESBYTERIAN  MEDICAL  CENTER,  NEW  YOR, 
NY -483,  EIR,  CORR  (01/01/2011  -01/01/2013) 

2013-77 

01/03/2013 
02/01/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Michelle  Minton 

The  Competitive  Enterprise  Institute 

DIET  COKE,  MOUNTAIN  DEW,  COCA  COLA,  ETC  -  AERS 
(01/01/08  TO  01/01/13) 

2013-78 

01/03/2013 
02/01/2013 

OM/OMP/DODM/ 

Dan  Litvin 

Garwin,  Gerstein  &  Fisher  LLP 

DKT  2007-P-01 1 ,  2008-D-0369  (CERTIFIED) 

2013-79 

01/03/2013 
02/01/2013 

FDA/OMPT/CTP/OD/ 

Rachel  Johnson 
FOI  Services,  Inc. 

SUBSTANTIAL  EQUIVALENT  TOBACCO  INFORMATION 

2013-80 

01/03/2013 
02/01/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Dolly  Mistry 
COVIDIEN 

K954300 

2013-81 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

BLA1 25084  S1 53 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2013-82 

01/03/2013 
02/01/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Kara  Morgenstern 
UNIVERSITY  OF  MICHIGAN 

COLUMBIA  PRESBYTERIAN  HOSPITAL,  NEW  YORK,  NY  - 
483  (07/01/2012  -  08/31/2012) 

2013-83 

01/03/2013 

ORA/OE/ 

WIEJIA  DAI 

MEDICAL  DEVICE  RECALL  DATA  (06/01/1976  -  12/31/2012) 

02/01/2013 

ORA/OE/ 

University  of  Maryland,  College 
Park 

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Total  Records:  9990 


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Control  # 

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Signature/  Requester 

Subject 

Due  Date 

201  3-84 

01/03/2013 

nvM/nnn/ 

\j  V  1 VI/  V_/  v/ L// 

li  iMp  ni  itnam 

UUIIC  [JU  U  ICtl  1  1 

IFRKY  PFT  TRFAT  IN^PFHTIONS  -  VlflFOS  PHOTOS  FTC. 
u  i  i  i  IV  i  i  i  i    in  i  f  \  i  1 1  \i  o  i  i  v/  i  i     mo     v  i  L/ 1  v/  o ,  i  nu  i  \-/o ,  i  i  \j 

02/01/2013 

NBC  UNIVERSAL 

(MARCH/APRIL  2012) 

2013-85 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

Thomas  Perl«;  MD  MPH 

1  1  1  V/ 1  1  1 CAO    1    \j  1  IO    1 V  1 1 — '  ,    1 V  1 1  II 

GENOTROPIN  NORDITROPIN  NLJTROPIN  ETC  -ANNUAL 

Vw/  1  1  N  v_/  1  1  1  Vw/  1     UN,    1  N  Vw/  [  1 1_/  1  1  1  1  Vw/  1     1 1  VI  ,    1  N  V/  1  1  1  Vw/  1     1  1  N  ,    1       1  W      /\  1  N  1  N  VJ  l\  1  

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BOSTON  UNIVERSITY  SCHOOL 

DISTRIBUTION  DATA  REPORTS 

FDA/OMPT/CDER/ORP/DIDP/ 

OF  MEDICINE 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-86 

01/03/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

Qtpup  Ai  ifpn 

VALSARTAN  FORFEITURE  MEMO 

V  1  \  1  Vw//  \  1  1  1  /  \  1  N    1    Vw/  III    1  II  VJ  1  11        1 VI  1  1  V  1  W 

02/01/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

COZEN  O'CONNOR 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-87 

01/03/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  V/  1 —  VJ/  1—/  1    Vw/  1/ 

INDIVIDUAL  RECS 

1  1  M  L/  1  V  1  L/  Vw/  /  \  L_    1  I  L_  V/  Vw/ 

02/01/2013 

WHITE,  HORTENSE  S 

201 3-88 

01/03/2013 

\J  1  /  Uu/  £_U  1  vJ 

FDA/OC/OES/DFOI/ 

INDIVIDUAL  RECS 

1 1  M  \-J  1  V  1  L/  \jnL    1  1 1  V_/VJ 

02/01/2013 

WHITE,  HORTENSE  S 

2013-89 

01/04/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

INDIVIDUAL  RECS 

05/29/2013 

ALFB/ 

GARCIA  JR,  NARCISO 

FDA/OGROP/ORA/SW-FO/DEN- 

DO/DEN-CB/ 

FDA/OGROP/ORA/CE-FO/CHI- 

DO/0  HI -OB/ 

FDA/OGROP/ORA/SE-FO/SJN- 

DO/SJN-CB/ 

2013-90 

01/04/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V/  V/  l_  1  1/  1  /  1    Vw/  1/ 

DANIEL  W  ERNSBERGER  ESQ 

L/ 1  \  1  VI  1  1  1        V  V    1  1  1 1  VI  v_/  1  /  l_  1  I  V_/  1— —  1  1    1  \-)  V/ 

BARD  ACCESS  SYSTEMS  INC  -  POWER  PICC  CATHETERS 

l—/ 1  \  1  1 1 — J    I  \  V/  V/  L_  V/  V/   Vw/  1  Vw/  1  1  1  v  1  V/    1  1  VI  V/        1     Vw/  V  V  l__  III     1  V/  V/    \_/  /  \  1  1   1  1       1  1  1  IV/ 

02/04/2013 

BEHREND  ERNSBEERGER,  PC 

MDRS 

2013-91 

01/04/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  Vw/ 1  v  1 1      1  /  V/  L/  1  11   1/  V_/  V/  l_  1  1/  1  /  1    Vw/  J/ 

HELEN  LEWIS 

1    1  1—  1  l__  1  VI    l_  1       V  V  1 

DAMON  4CLEAR  K081415 

L/  /  VI  v  1  Vw/  1  VI        V/  1—  1  l  \  \  1    1  V  V/  V/  1        1  v/ 

02/04/2013 

DENTSPLY  INTERNATIONAL 

2013-92 

01/04/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  \J  L/  1  11   1/  v/  V/  l_  1  1/  1  /  1    Vw/  1/ 

HELEN  LEWIS 

1   1  1—  1  l__  1  VI    l_  1      V  V  1  V/ 

EMPOWER  CLEAR  K1 22753 

1  1 V  1  1     V«/  V  V  1  1  I   V/  I—  I—  /  V 1  1    1  V  1  £_  L—  i  \J\J 

02/04/2013 

DENTSPLY  INTERNATIONAL 

?m  3-P3 

01/04/2013 

FDA/OMPT/nnRH/nnFR/nFm/ 

i  \—Jf\/  v_/ivi  n  i  /  v/  L/  rii  i/  v/  v_/ 1  n/  i_/  i  v_y  i/ 

1  II  l_  1  IN  l_  1  V  V  IO 

C.\  ARITY  MDDIFIFD  HFRAMIT,  RRAP.KFTS  K0fi?305 

V_/ \  1  1 1  1    I    IVIv/L-MI    II  VJ  v/ 1  1  \r\  1 V 1 1  w  L_)  1  l/vV^/lvl      1  O  IwUtOUJ 

02/04/2013 

DENTSPLY  INTERNATIONAL 

2013-94 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

CAERS  150606,  150166 

02/04/2013 

I0VATE  HEALTH  SCIENCES 

INTERNATIONAL  INC 

2013-95 

01/04/2013 

FDA/OF/CFSAN/OCD/EOS/ 

RED  BULL,  5  HOUR  ENERGY,  MONSTER,  ROCKSTAR 

02/04/2013 

Doe  J 

ENERGY  DRINKS  -  CAERS 

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Total  Records:  9990 


/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2013-96 

01/04/2013 
02/04/2013 

FDA/OC/OES/DFOI/ 

WHITE,  HORTENSE  S 

INDIVIDUAL  RECS 

2013-97 

01/04/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \J  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

JOANNE  S  HAWANA 

\j  v_/ 1  \  i  vi  i  >i  i_  Vw/  i  1 1  \  v  v  i  v  i  v 

ISRS  8255707  8439906  8444371  ETC 

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02/04/2013 

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ARENT  FOX  LLP 

2013-98 

01/07/2013 

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02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

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Rarhpl  Johnson 
FOI  Services,  Inc. 

K121876 

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2013-99 

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02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

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Rarhpl  Johnson 

1  ldV.fl  lul   UUI  II  IOV/1  1 

FOI  Services,  Inc. 

K020791 

2013-100 

01/07/2013 
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FDA/OMPT/CDRH/OCER/DFOI/ 

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FOI  Services,  Inc. 

K090435 

2013-101 

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FDA/OMPT/CDER/ORP/DIDP/ 

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Dph  Hnnprman 

NDA  21829  S  001  002 

1  M  1  '  1    \    L—    1  V/  L—                     V/  V/    1    *     V/  \_/  L_ 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

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FDA/OMPT/CDER/ORP/DIDP/ 

UCB,  Inc. 

2013-102 

01/07/2013 
02/05/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Becky  Cooseman 
Brown  &  Crouppen,  PC 

MEAD  JOHNSON  NUTRITION  -  REPORTABLE  FOOD 
REGISTRY  REPORTING  (01/01/2002  -  01/03/2013) 

2013-103 

L—\J    1  \J      1  \J\J 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  L-/  1  ]  /  1  / 

1  aird  Forrp^t 

1 — Cll  1         1    Ul  1  COl 

ABRAXANE  IND  -  505(BW2)  APPLICATION 

/  \  E  >  1  I  /             W  h  \        1  1  N  1 — /        JUvl  1  }  J  \  L—  J    1  V 1     1     L_  1  WM  1  1  V-/  1  N 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

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HylaPharm 

2013-104 

01/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Karin  Desjardins 

K962577 

02/05/2013 

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COVIDIEN 

2013-105 

01/07/2013 

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FDA/OMPT/CDER/ORP/DIDP/ 

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Dan  1  itvin 

L/  CX  1  1    ^  1  I  V  1  1  1 

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02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

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FDA/OMPT/CDER/ORP/DIDP/ 

Garwin,  Gerstein  &  Fisher  LLP 

2013-106 

01/07/2013 

V/    1  /  \J  i   1  L —  \J    1  \_J 

02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Qiuhu  Shi 

NEW  YORK  MEDICAL  COLLEGE 

K051672,  K072625,  K102159 

2013-107 

01/07/2013 
02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Amy 

Weisman,  Kennedy  &  Berris 

K003363 

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2013-109 

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PROJECT  ON  GOVERNMENT 
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MERCK  -  ZOSTAVAX  SHINGLES  PREVENTION  STUDY 
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OKA/UKM/ 
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f\  A  1 1     1  rooi^l/ 

(jAIL  LtbblGK 

LACHMAN  CONSULTANT 
SERVICES  INC 

P\/"\IV  (COTI^    Akin  fZt~^\  n  r~  1      K  1  1  k  1  PDrnTiAiiO     4  4  H    OA/HO     nni  |A 

LKJMtb  1 IC  ANU  rUKtKjN  INbrtO  1  lUNb,  11/1  -30/1 Z,  UHUCj 
COMPANIES  MDM  BIMO  AND  GLP 

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2013-111 

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02/05/2013 

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HylaPharm 

2013-1 12 

01/07/2013 

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Self 

2013-113 

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FDA/OF/CFSAN/OCD/EOS/ 

NICOLE  C.  ANDERSEN 

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02/05/2013 

OC/COS/OES/ 
OC/COS/OES/ 

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2013-1 14 

01/07/2013 

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Frir  H  Wpinhprn  F^n 

1  1  1  V»j    1   1.    V  V        1  1  k/ 1  VJ  j    1—  O  V—l  ■ 

NDA  22512  S01 1 

1  *J  L/  /  V  L_  £_  Vw*  1  L_    O  V/  1  1 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Firm  of  Eric  H.  Weinberg 

2013-1 15 

L_  \J   1  \J      1     1  xj 

01/07/2013 
02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

i  i — '  /  v/  \w/ 1  v  1 1     i  /  v/ 1_/  i  i  i/  w  ill   /  (_/  1 1_/  i  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V-/  III    /  1 — '  1  l_/  1  / 

DON  J  MIZERK 

L/  V-/  IN   VJ    1 V  1  1 £  1  1   II  V 

HUSCH  BLACKWELL  LLP 

MALLINKRODT  INC  -  METHYLPHENIDATE  HCL  ANDA  202- 

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608  APRVLLTR  12/28/12 

2013-116 

01/07/2013 
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OM/OMP/DODM/ 

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AudismFreeAmerica 
Audi^m  Frpp  Amprira 

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EFFICACY  OF  COCHLEAR  IMPLANTATION  WITH  YOUNG 
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06/28/85) 

FDA/OMPT/CDRH/OCER/DFOI/ 

2013-117 

01/07/2013 
02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Marilyn  Peguero-Fain 
freelance  reporter 

CRANIAL  ORTHOSIS  DEVICES  -  COMPLAINTS,  FULL 
REPORTS 

2013-1 18 

01/07/2013 

V/    \  1  \J  t  1  L —  \J  1 

FDA/OMPT/CDER/ORP/DIDP/ 

ELLIOT  FAVUS,  M.D. 

XTANDI  (ENZALUTAM  DE,  MDV3100)  -  AERS  1/1/10  TO 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FAVUS  INSTITUTIONAL 
RESEARCH  LLC 

PRESENT 

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Raiipn  Arv?il 

ocijjoi  i  ni  ycii 

MSN  LABORATORIES  LTD  ANDHRA  PRADESH  INDIA  -  EIR 

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02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Accucaps  Industries  Limited 

(03/5/12) 

2013-120 

01/07/2013 

\J  V  1  \J  1  1  L—\J   1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

Orannp  Ronk  arrhivp 

Vw/  1  Cll  'M  v  1— ' V/ v/ 1 V  CI  1  VjI  1  1  V  \D 

ORANGE  BOOK  -  200B 

Vw/ 1  ir\i  iivji   i— ' Vw/ Vw/ 1  \  l-uwu 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DATAMONITOR  HEALTHCARE 
CONSULTING 

2013-121 

01/07/2013 
02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   \w/  1  V  1  1          1    /   V  '  L/  1         1     1/   \w/  III       /    \—S   1  1  /  1  / 

OC/COS/OES/ 
OC/COS/OES/ 
OM/OMP/DODM/ 

Rachel  Johnson 
FOI  Services,  Inc. 

THALIDOMIDE,  THALOMID  -  COMMUNICATIONS, 
APPROVALS,  RESTRICTIONS,  ETC 

2013-122 

01/07/2013 
02/05/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

MARY  SCHWAGER 
WHDH-TV  INC 

D'ORO  FOODS  INC,  MALDEN,  MA;  GATE  GOURMET  INC 
UNIT  231 ,  EAST  BOSTON,  MA;  DELTA  AIR  LINES  INC,  EAST 
BOSTON,  MA,  ETC  -  483S 

2013-123 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

Dph  Hnnprman 

1— •*  V^  k/    1   IUUCI  1  1  IC4I  1 

BLA  125160  S  080 

1  '  L_  /  \     1  L—  v/  1  \J\J    \J  V/V/W 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  V/  L-/  1  1  1/  \-s  III    /  ( — /  I  ]  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

UCB,  Inc. 

2013-124 

01/07/2013 
02/05/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \  '  1  }  1—  1  1/  \—s  Vw/  W  1—/  /  1 — /  1 — ^  Vw /  1 V  1/ 

ALFB/ 

Doe  J 

INTRADERMAL  VACCINE  LOT  NUMBER  UT4463AA  -  VAERS 

IIM  1  1  1 1  \  L/  1  1  1 1 V 1 1  \  \        V/TJvll  NI        1  Vw/  1     1  >IUIVIUI  1  I    \J  1     i    i  WO                   V  /  V 1  1  I V  ) 

2013-125 

01/07/2013 
03/13/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  VwS  1  J  l__  1  1/  Vw/  Vw/  Vw/  1— /  /  1  /  1  J  Vw /  1 V 1/ 

ALFB/ 

Waltpr  KvIp 

v veil lci  i\yic 

Walter  Kyle 

ipu  Pipv  .  IJNPUBLISHED  DATA  AVAILABLE  FROM  SANOFI 

II      V  ,    1  II      V         VJ  1  >l  1     \J  l—J  1  1  \J  1   1 1  L/    L/  /  V  1  1  \  I  \  V  1  \  1 1  r\ui  1        1    1  I  V  1 1 VI    V//  V 1  *J  Vw/  1  1 

PASTEUR  SA  AND  INC 

2013-126 

01/07/2013 
02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  / v  Vw/  1  v  1  1      1  /  v/  L/  1  11   1/  V_/  V/  l_  1  1/  1 — /  1    Vw/  1/ 

Anrlrpa  Mrflrpprlv 
/\  i  iui  cci  iviuv/i  cciuy 

McCready,  Andrea 

K030765  K844550 

2013-127 

01/07/2013 
02/05/2013 

OM/OMP/DODM/ 

Walter  Kyle 
Walter  Kyle 

VRBPAC  -  TRANSCRIPTS  (07/29/85,  7/30/85) 

2013-128 

01/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Jonathon  Dohertv 

\J  v/ 1  lull  iui  i  i— /  v/ 1  i  v_- 1  ly 

XANAX  -  CLINICAL  TRIALS,  CORR 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Milagro  Community  Care 

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Frir  SohmiHt 

1  l  l\j  \J\jl  II  1  1 IU  L 

BREAKTHROUGH  CANDIDATES 

>S  1    11  1   \  1  V  1    1    II    1  \S  W  V  A  1    1    Vw//   V 1  V|  IS  J  \S  1  \  1    1  Vj 

02/05/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  is  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

COWEN  AND  COMPANY 

2013-130 

C—  \J  1  \J     1  \J\J 

01/07/2013 

ORA/ 

INDIVIDUAL  RECS 

1 1  vi  lw/  i  v  i  is  Vw/  /  \  i      i  1 1_  Vw/  Vw/ 

02/05/2013 

ORA/ 

Doe  J 

2013-131 

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01/07/2013 
02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  \S  1 V  1  1      1  /  \S  IS  1  11   1/  W  \w /  l_  1  1/  \S  1    Vw/  1/ 

MONIKA  BHATT 

i vi \*/ 1  vj  1 1  \n  is i  i /  \  i  i 

HODGSON  RUSS  LLP 

3M  -  LAVA  ULTIMATE  CAD/CAM  RESTORATIVE  K1 22569 

\J  1  V 1           l—t \  V  l  \    Vw/  1      1  1  1 V 1  /  \  1   1        Vw/  /  \  1—/  /  V_/  / \  1  VI    II 1— —  Vw*  1  V_/  1  I  /  \  1   1  v  1        1  \  1  L—  I—  \J  \J  *_/ 

2013-132 

01/07/2013 

\J  1  /  \J  1  1  L—\J   1  O 

FDA/OMPT/CBER/OCOD/DDOM/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  Is  l__  1  1/  Vw/  V/  Vw/  L/  /  IS  IS  Vw/  1 V  1/ 

MARTIN  RUBENSTEIN 

1  V  1 1  \  1   1  1   1  1  N    11  Vw/  IS  1  1  N  U  1  1  1  1  *l 

INDIVIDUAL  RECS  -  VAERS 

1 1  vi  lw/  i  v  i  is  Vw/  /  \  [_  i  1 1  Vw*  Vw/       v  /  v  i  i  i  vj 

04/04/2013 

ALFB/ 

HOWARD  M  FILE  ATTY 

2013-133 

t—\J  1  \J    1  \J\J 

01/07/2013 
02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  Vw/  1 V  1  1      1  /  \w*  1— /  1  11   1/  Vw/  Vw/  1— —  1  1/  1  /  1    Vw/  1/ 

FDA/OC/OES/DFOI/ 

BRIANNE  RIDEOUT 

IS  1  1  11  VI  il  i  1        1  1  1  IS  1  Vw/  «w/  1 

ASHCRAFT  &  GEREL  LLP 

CELLULAR  TELEPHONE  DVCS-  SCIENTIFIC  STUDIES 

Vw/  1  1  1  *S  l—t  \  11     1  1  1  1  1     1   1  Vw/  1  VI  l__    IS  V  Vw/  V_/      V_/  Vw/  1  1— —  1  VI  1  1  1     1  v/    v^/  1  Vw/  lw/  1  1  Vw/  , 

CORR,  INVESTIGATIONS,  ETC 

2013-134 

01/07/2013 

\J  V  1  \J  1  1  L—\J   1  V/ 

02/05/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       lw/  1    \!   Vw/  |  V  1  1          1    /  Vw/  lw/  |     11      1/   Vw/  Vw/  1— —  1     1/    1  /  1       Vw/  1/ 

J  DONALD  HENSON  SR 

KJ  m       IS  Vw/  1   V|  1    *  1        lw/      |      |  1         |    >J  Vw/  Vw/  1   1|  j      V_/  |  | 

HENSON  SR.,  J.  DONALD 

MEDTRONIC  -  INSULIN  PUMP  P980022  RECS 

1  V  1  1       IS   III  Vw/  |  VI  1  Vw*          1  1  V|  \S  \J  l_  1  1  ^1     1      \J  1  V 1  1        1     \J\J\J\J  L—  L—    11  UV/vJ 

2013-135 

01/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       lw/  /    V/   Vw/  |  V  1  1           1    /   Vw/  lw/  |     11      1/   Vw/  Vw*  1— —  1     1/    1  /  1       Vw/  1/ 

KYOCERA  Medical  Cornoration 

1  v  1  \S  Vw/  1  1  L V \    1 V  1  ^Vwl  1  O  CI  1    Vw/  W  1  !_/  v/  1  d  L 1  v/  1  1 

K041940 

1  V  V/       1  \J  V/ 

02/06/2013 

FDA/OC/OES/DFOI/ 

KYOCERA  Medical  Corporation 

2013-136 

01/08/2013 
02/06/2013 

FDA/OC/OES/DFOI/ 

JOHN  A.  HOWARD-ALGARIN 
BAMUNDO  ZWAL  ET  AL 

LAPAROSCOPIC  TOCAR  INJURIES  RPT  -  CERTIFIED  COPY 

2013-137 

L_  v/   1  \J      1  / 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1 V  1  1      1  /  Vw/  lw/  1  1  1/  Vw/  III    /  lw/  1  lw/  1  / 

Rohprt  Harris 

I  IV/k/t/l  I   1    ICll  1  IO 

NDA  008372-  NDA  01 7861  ■  NDA  01 0831  ETC 

1  N  iS  1  \  \J\J\J\J  1  C—  ^    1  VI  IS  I  \  \J  1   /  \J  \J  1  ,    1  N  iS  1  \  \J  1  \J\J*S  1     1       1  Vw/ 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Biosim 

2013-138 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

LABPE.COM  -  SALE  OF  PEPTIDES,  ANABOLIC  STEROIDS 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  Vw/  lw/  1  1  1/  Vw/  III    /  IS  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

ORA/OCI/ 

ANDERSON,  CARL. 

1/11  TO  PRESENT 

2013-139 

01/08/2013 
02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
ORA/OCI/ 

ANDERSON,  CARL. 

AJ  GLOBAL  LTD,  DERL  &  EXTREME  PEPTIDES.COM  -  SALE 
OF  PEPTIDES,  ANABOLIC  STEROIDS  1/11  TO  PRESENT 

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Reed  Date  / 
Due  Date 

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Signature/  Requester 

Subject 

ORA/OCI/ 

2013-140 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Bill  Orr 

CHANTIX  -  AERS 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Bill  Orr 

2013-141 

01/08/2013 
02/06/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

E.J.  Smith 
Smith  Associates 

K060866 

2013-142 

01/08/2013 
02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Dan  Reed 

Celsus  Laboratories,  Inc. 

SHENZHEN  HEPALINK  PHARMACEUTICAL  CO  LTD, 

uUAINuUUINo  rnUVINOt,  On  I  IN  A  -  4oo  ,  tin  (11/1  0/*iUUo  - 

01/07/2013) 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-143 

01/08/2013 
02/06/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

E.J.  Smith 
Smith  Associates 

K001368 

2013-144 

01/08/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

Glenn  Irish 

SHIRE  HGT-483  (11/07/2011  -01/07/2013) 

02/06/2013 

ALFB/ 

Glenn  Irish  Consulting 

2013-145 

01/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

BioCare 

K002712 

02/06/2013 

FDA/OC/OES/DFOI/ 

Biocare  Enterprise  Limited 

2013-146 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Ismail  Elchagea 

NEXAVAR  TABLETS  -  IND,  NDA 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

International  Trading 
Pharmaceutical  Lab 

2013-147 

01/08/2013 

CVM/OCD/ 

ELISABETH  HOLMES 

ZILMAX  (ZILPATEROL)  APRVL,  AER,  WARNING  LTRS 

02/06/2013 

OC/COS/OES/ 
OC/COS/OES/ 
OM/OMP/DODM/ 

CENTER  FOR  FOOD  SAFETY 

2013-148 

01/08/2013 
02/06/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

UU/  rvAIN-wD/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

OZBURN  HESSEY  LOGISTICS  WAREHOUSE,  KANSAS  CITY, 
IVIU  -  tin 

2013-149 

01/08/2013 
02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

PATHEON  BURLINGTON  CENTURY  OPERATIONS, 
BURLINGTON,  CANADA  -  EIR  2/1 1 

2013-150 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M.  GARTZ 

PATHEON  TORONTO  REGION  OPERATIONS,  MISSISSAUGA, 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

CANADA  -  EIR  2/11 

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/"V  1  1  If 

Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-151 

01/08/2013 
02/06/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

II —  All    /""»  /""\R  /II  7 

LEAH  GOMEZ 

THE  HUMANE  SOCIETY  OF  THE 
UNITED  STATES 

rM\/inAMH*rMTAi    ^MIJAM/P1^^^^MT  ni  am  r^r~\r~>  ni/^ni  lii  imam 

ENVIRONMENTAL  ENHANCEMENT  PLAN  FOR  NON  HUMAN 
PRIMATES  BY  HSUS 

1       1    IIIVI/V   1    1—  Vw?     1  *     1       1  IVjsJVj 

2013-152 

01/08/2013 

OC/OOPD/ 

Herriot  Tabuteau 

CALCITONIN  HUMAN  FOR  INJECTION  -  ORPHAN 

02/06/2013 

FDA/OMPT/OSMP/OOPD/ 

Axsome  Therapeutics,  Inc. 

DESIGNATION 

2013-153 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \J       1  1  1/  V_/  III    /  I — '  1  1— '  1  / 

Ya  Pinn  1  pp 

i  Q  I    ||  iy  I — 

OMEPRAZOLE  ESOMEPRAZOLE  LANSOPRAZOLEM  ETC  - 

Vw/ 1  v  1 1— —  1     1  1 1  \i  \S  1  l_  ,    l_      Vw/  1  v  1 1  1     1   1 1  \  L  \—S  1  1  ,    1  1  \  1  VI  vJ  Vw/  |     |  1  y  \Z  Vw/ 1_  I  |  v  1  1— —  1  Vw/ 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L_/  1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

School  of  Pharmacy  Curtin 
University 

AERS 

2013-154 

01/08/2013 
02/06/2013 

FDA/OC/OES/DFOI/ 

1  1— <*V  Vw/  Vw//  \w/  1 —  VJ/  1—/  1     VwX  1/ 

.lohnathan  Rirkman 

\J\J\  II  Idll  Idl  1    1  UvlM  1  1  CI  1  1 

FDANEWS 

FOIA  LOG  M  2/31/201 2  -  01/04/2013} 

1    Vw/  1  / \  1 —  Vw/ I    |  £_/  U  l/LV  1  L.        \J  \  1  V/~/  L—\J\\JI 

2013-155 

01/08/2013 
02/06/2013 

FDA/OGROP/ORA/CE-FO/CIN- 

1    L*/  /  V/  Vw/  \J  1  I  Vw/  1    /  Vw/  1  11  \I  Vw/  1— —    1    Vw//  V  '  1  1  VI 

DO/CIN-CB/ 

Dan  RppH 

1— •*  OA.  1  1    1  I^UU 

Celsus  Laboratories,  Inc. 

PHARMACIA  HEPAR  INC  FRANKLIN  OH  -  483  EIR  CORR 

1     1   1/ VI  1 1 V  1 1  \  \—S  1 1  \    1   1  l_  1    1  \  11    1  1  VI  Vw/  <    1     1   I  /  V 1  VI  1  \  L>  1  1  V]  ,    Vw/  |   |        ^Uu  ^    1  II  I  ^    Vw/  Vw/  1  1 1  I 

(01/01/2011  -01/07/2013) 

2013-156 

01/08/2013 
02/06/2013 

FDA/OGROP/ORA/PA-FO/SEA- 

1  1 — '  /  V/  Vw/  VJ  1   1  V_/  1    /  Vw/  1  IV  V/  1    / \    1    \^/t  \J  I—  I  \ 

DO/SEA-CB/ 

KRISTINA  FRYE 

i  \  i  ii  Vw/  i  1 1  vi  /  v  i    ill  i  

FRYE  ELECTRONICS 

FRYE  ELECTRONICS  TIGARD  OR  -  EIR  6/22-7/3/12 

1     III   1        l_  1  l_  V-/  1  1  1  Vw /  1  VI  1  Vw/  Vw/  .     II  Vh*4  /  \  1  I  lw/  ,    Nw/  1  1        1  III   V//  £_  L_     t  t  \J1    1  L_ 

2013-157 

01/08/2013 
02/06/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

E.J.  Smith 
Smith  Associates 

K972527 

2013-158 

01/08/2013 
02/06/2013 

F  D  A/OG  ROP/0  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

FDA/OGROP/ORA/CE-FO/PHI- 
DO/PHI-CB/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 

Richard  P  Dickey,  MD,  PhD 
Fertility  Institute  of  New  Orleans 

IVF  CLINICS  -  DISASTER  RESPONSE  INSPECTIONS 

(08/21/12-8/30/12) 

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V_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  laLUl  u/  nULjUtJolci 

OUUJtfOl 

DO/DAL-CB/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

201  S-1  W 

01/08/2013 
02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  '  / V/  Vw/ 1 V  1  1      1  /  \J  1—/  1  1  1/  V_/  III    /  1— /  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

L ORAZFPAM-  DIPHENHYDRAMINE-  DOXEPIN-  VALPROIC 

1  Vw/  1  \r\£—  1  1     /  V  1  V  1  .  L— '  1 1     1   II  1  V  1   1   1   1  '  1  1/  VI V  1 1 1  Ml  ,    1  '  \7  /  \  1  1     II*]     V  1  \  1  1     1  1  Vw/  1  V/ 

ACID  SYRUP;  MIRTAZAPINE  -  AER 

2013-160 

01/08/2013 
02/06/2013 

FDA/OGROP/ORA/ORO/DIOP/ 

DONALD  BLUE 

GLOBAL  TRADE  INTELLIGENCE 
INC 

IMPORT  20120103-1 

2013-161 

01/08/2013 
02/06/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

MURIS  DEMIROVIC 
FDA  NEWS 

MINDRAY  DS  USA  INC,  MAHWAY,  NJ  -  483  6/1 1/12  -  8/2/12 

O  A  H  O    H  AO 

2.0  \  o-1  o2 

01/08/2013 
02/06/2013 

rUA/UMr  1  /OBtK/UCOU/UUlJlvl/ 
ALFB/ 

IAUM       D  C\ A/HPAM 

JOHN  OKtWUbUN 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

MtKOK  -  HtKHtX  ZUo  1  tK  KtCOKUtU  IN  1  He  MINI 
SENTINEL  DATABASE  AER 

2013-163 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1—/  1  ]  /  1  / 

GAVIN  ANDERSON 

\—A  /  \  V  II  l    i  \  1  *l  L/  1  1  I  VwJ  Vw/  1  >J 

DOXIL  NDA  50-718  -  SUPPLEMENTAL  NDA 

L/V//M  1—   1  N  1  /  /  \   v/  V/    /     1  \J  ^— /  V/  1     1     1— 1_  1  V 1  1  1  N  1  1  \  1—   1  *J  1  /  1  \ 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

AZAYA  THERAPEUTICS  INC 

2013-164 

01/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

BRUCE  W  STECKLER 

1  f  1  l  \-/  \J  l__    li.    \_/  1  l_  V/  1  \  1  l_  1  I 

AMGEN  INC  -  EPOETIN  ALFA  (EPOGEM 

/  11 V  1  Vwl  1— —  1  M    IIM  \J        1  1     Vw/  1       1  1  1       1  \  l_  1    / \   1  l_  1     \  '  Vwi  1  1  N  / 

02/06/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  t — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

STECKLER  LAW  LLP 

2013-165 

01/08/2013 
02/06/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  l__  1  1/  1  /  1    Vw/  1/ 

HENSON  SR.,  J.  DONALD 

PMA  P980022 

1      IVI/%    1     \J  V/  v/  V/  L—  L_ 

2013-166 

01/08/2013 
02/06/2013 

OC/OM/OMP/DDM/ 

SEAN  CRANSHAW 

THE  PEW  CHARITABLE  TRUSTS 

DKT  1993N-0029,  1980N-0446,  ETC. 

2013-167 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Aaron  Diamant 
WSB-TV 

GATE  GOURMET,  ATLANTA  HARTSFIELD  JACKSON 
INTERNATIONAL  AIRPORT  -  EIR,  WARNING  LETTER,  CORR, 
ETC  (12/01/2012  -  01/07/2013) 

2013-168 

i. —  V/  1  O  1 

01/09/2013 

v/   1  /  V/v//  t —  V/   1  V_J 

02/07/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

Dan  Rppd 

l/UI  1    1  IvvU 

Celsus  Laboratories,  Inc. 

SCIENTIFIC  PROTEIN  LABORATORIES  LLC,  WAUNAKEE,  Wl 
-  483,  EIR  (12/09/2009  -  01/07/2013) 

2013-169 

01/09/2013 
02/07/2013 

OC/OM/OMP/DDM/ 

CARLA  SCARMAZZI 
KING  &  SPALDING 

DKT  FDA-2012-N-0378 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201  "3-1 70 

01/09/2013 
02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     1  /  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \m/  L-/  1  1  1/  \-s  III    /  I — f  I  l_/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Dan  Rpprl 

l— '  dl  1   1  1CCU 

Celsus  Laboratories,  Inc. 

NANKING  KING-FRIEND  BIOCHEMICAL  PHARMACEUTICAL 

1  <ini  XIMI  MVul    l\IIM\wl    1    1  III  1  N  l_/    UIWWI   II  IVIIWrVL    1     1   1 1  \  1  llvl/\V_/|  \J  1  1  Vw/ / V 1  

CO,  JIANGSU  -  483,  EIR  (09/01/2009  -  01/07/2013) 

2013-171 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Dan  Reed 

Celsus  Laboratories,  Inc. 

ORGANON  API,  INC,  SIOUX  CITY,  IA  -  483,  EIR  (02/01/2009  - 
01/07/2013) 

2013-172 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — /  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

Dan  Rppd 

BIOBERIOA  SA  BARCELONA  SPAIN  -  483  EIR  C03/1  5/2009  - 

i  )  i  v_/ 1  )  i  i  ii  \s  r  \ ,  w  r\ ,  i—ji  \  i  i  \w/ 1  i  Vw/ 1  Nn,  w  i   1  \  1 1  m      tuvI;  i  1 1  i  i  uu/  i 

02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Celsus  Laboratories,  Inc. 

01/07/2013) 

2013-173 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Ann  M.  Carvalho 

McLarens  Global  Claim  Services 

SNYDER'S  LANCE,  CHARLOTTE,  NC  AND  COLUMBUS,  GA  - 
INVESTIGATION  RECS,  REPORTS,  INSPECTION  RECS  ETC  ( 
03/01/2012-01/07/2013) 

2013-174 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Angelia  Slayton 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

K121598 

2013-175 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L_/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

.Ifltnp^  Cnllip 

J.  R.  Collie  Associates,  Inc. 

K1 02758 

2013-176 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  11   1/  \-s  w  l__  |  |/  I — /  |    Vw/  1/ 

Rpttv  Johnson 
Betty  Johnson 

K1 02727 

2013-177 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

i    J  /  /  v/  \w/ 1  v  1 1     ii  \j  i—s  i  ii  i/       v  '  i_  i  i/  i  /  i   Vw/ 1/ 

Rpttv  .Inhn^nn 
Betty  Johnson 

K121091 

l  \  1  L  1  1 

2013-178 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Betty  Johnson 
Betty  Johnson 

K1 13479 

2013-179 

01/09/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Angelia  Slayton 

K1 10735 

02/07/2013 

FDA/OC/OES/DFOI/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2013-180 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Mick  Fenton 

Immunodiagnostic  Systems  Ltd 

K831178 

2013-181 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  ( — /  I  ]  /  I  / 

EMILY  K  STRUNK 

l_  1  V 1  1 1—  1     1  \  \J  1  1  l  Vw^  1  Y 1  \ 

XANDI  (ENZALUTAMIDE^  -  AERS  8/31/12  TO  PRESENT 

/  v/  vi  *j  (  /  i  \  i_  i  n  i.  1  \  i  \j  i  i  v  i  v  1 1 1 — ^  i  /       /  \  i  i  i  Vw^  \ji  \j  \  i  \  L—    i  Vw/  i    ii  i_  \_j  i_  i  n  i 

02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

AKIN  GUMP  STRAUSS  HAUER  & 
FELD, LLP 

2013-182 

01/09/2013 

OM/OMP/DODM/ 

JANNA  DEPORTER 

DKT  1999P-2630 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

02/07/2013 

CENTER  FOR  SCIENCE  IN 
PUBLIC  INTEREST 

2013-183 


2013-185 


01/09/2013 
03/15/2013 


2013-184  01/09/2013 
02/07/2013 


01/09/2013 
02/07/2013 


ORA/ 
ORA/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/DFOI/ 


PATTI  WELLER 
MARLER  CLARK  ATTYS 


GAIL  C  TRABISH  ESQ 

BOORNAZIAN  JENSEN  & 
GARTH E  PC 


ELENA  HOWELL 
HOGAN  LOVELLS  US  LLP 


STATE  GARDEN  INC  -  ORGANIC  SPINACH  AND  SPRING  MIX 
BLEND  E  COLI  OUTBREAK  INVESTIGATION  RECS,  LAB 
RESULTS,  CORR,  ETC11/2/12 


VALIDUS  PHARMS 
ETC 


2012-8987 


EQUETRO  CORR,  APRVL  RECS,  LBLG, 


2013-186 


2013-187 


01/09/2013 
02/07/2013 

01/09/2013 
02/07/2013 


FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OF/CFSAN/OCD/EOS/ 


JENNIFER  CONNER 

AMERICAN  CLAIMS 
MANAGEMENT  

MARILYNN  WHITNEY 

COVINGTON  BURLING  LLP 


BRIGHT  REHAB  SOLUTIONS  INC,  BAKERSFIELD,  CA; 
GLENDALE,  CA  -  IMPORTER  REGISTRATION,  EIRS,  483S, 
ETC  2009  TO  PRESENT 

COCA-COLA  -  FULL  THROTTLE  &  NOS;  DR  PEPPER- 
VENOM;  PEPSICO  -  AMP  &  ADRENALINE  RUSH  CAERS 


2013-188 


01/09/2013 
02/07/2013 


FDA/OMPT/CTP/OD/ 


MARILYNN  WHITNEY 
COVINGTON  BURLING  LLP 


TOTAL  NUMBER  OF  PROVISIONAL  AND  NON-PROVISIONAL 
TOBACCO  PROD  SUBSTANTIAL  EQUIVLENCE  (SE)  RPTS, 
MODIFIED  RISK  TOBACCO  PRODS,  ETC 


2013-189 


01/09/2013 
02/07/2013 


FDA/OC/OES/DFOI/ 


JOHN  CREWDSON 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 


RANBAXY,  OHM  -  BLOOMBERG  NEWS,  NEW  YORK  TIMES 
ATORVASTATIN  REQUESTS 


2013-190  01/09/2013 
02/07/2013 


2013-191 


01/09/2013 
02/07/2013 


2013-192  01/09/2013 
02/07/2013 


FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


JOHN  CREWDSON 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 


Heuston,  Brian 


MEMOS,  CORR,  EMAIL  WHICH  DISCUSS  THE  INCIDENCE  OF 
HERPES  ZOSTER  DURING  THE  POST-MARKETING  PERIOD 
IN  INDIVIDUALS  VACCINATED  WITH  ZOSTAVAX 

ADVIL  PM  -  AERS 


TYLENOL  PM  -  AERS 


Heuston,  Brian 


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Total  Records:  9990 


Pnntrnl  if 

rit?OU  Udlc  / 

Due  Date 

MOLIUll  wlllLrC 

OlyildLUlu/  r\t3L]UubLcr 

Ci  i  il™iiQ/^t 
OUUJfcJGl 

FDA/OMPT/GDFR/ORP/DIDP/ 

1    1  •  1  \i  V_/ 1 V  1 1      11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \m/  L-/  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-193 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

PROVIMI  NORTH  AMERICA,  LEWISBURG,  OH  -  EIRS  3/1 1 , 
10/11 

2013-194 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — /  1  \!  \s  1 V  1  1      1  /  \S  IS  1  1   If  W  III    /  L*/  1  J  /  1  / 

BRENDA  M  GARTZ 

IS  1  1 1__  1  VI  IS  I  \   1  v  1    \S\t  VI   1  1  L  

OILU  PHARMACEUTICAL  FACTORY  JINAN  CHINA  -  EIR  7/1 1 

vj<  1 1  w  i   i  i  /\  i  uvmui  \j  i  i  \s  n  i     i  nu  i  \_/i  i  i  ,  uii        i,  v_/i  iiiMn     i  ii  i  //  i  i 

02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  \S  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2013-195 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/SE-FO/ATL- 

i   is  i  \!  \w/      i  i  \s  i  /  v-/ 1  \  i  \t  i— _  i  Vw/ /  /  \  i  i  

DO/ATL-CB/ 

BRENDA  M  GARTZ 

IS  1  1 1__  1  VI  IS  I  \   1  v  1    \-A  1  VI   1  1  L  

ELI  LILLY  &  CO 

SANDOZ  WILSON  NC  -  EIR  6/11 

Vw/  /  VI  *J  (  /  \S  i.  ,    V  V  1  l—  VwJ  Vw/  1  Vj    IX  V/        l_  1  1  l  V//    1  1 

2013-196 

01/09/2013 
02/07/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

LISA  BURNS 

CHURCH  &  DWIGHT  CO  INC 

SPD  SWISS  PRECISION  DIAGNOSTICS  GMBH  -  K1 12870 

2013-197 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  I — /  1  IS  1  / 

ALBERTO  ORTEGA 

/ \  L_  IS  l__  1  1  1  V/   Vw/ 1  1  1  1  1  \ 

ORANGE  BOOK  NDC  DIRECTORY  2001  TO  201 1 

Vw/  1   V  i  \  1  M        l_    L/V/V/  IV-    1  N  1 — '  V/  1 — /  III  l_  V/  1  Vw/  III     L_  \/  \/  1      1  Vw/    £_  V/  1  1 

02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIV  OF  FLORIDA  WARRINGTON 
COLLEGE  OF  BUSINESS 

2013-198 

t—\J  1  \J    1  v/  v/ 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  1— /  1  ]  /  1  / 

C  RICHARD  MARSHALL 

\S    1   1 1  \J  1   1 1  \  J  1  L/    lvl/%1  I V/  1    1  / \  I—  1— 

TRAMADOL  - AERS 

1  1  l/\l  V  11  V  IS  V/  1           1  \  1—  1  1  VwJ 

02/07/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  > — /  III    /  IS  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

C  RICHARD  MARSHALL  LAW 
OFCS 

2013-199 

01/09/2013 
02/07/2013 

FDA/OGROP/ORA/CE-FO/CIN- 

1    IS  1  \l  Vw/  V/  1   1  V_/  1    /  Vw/  1  1/  V/  V_/  l_    1    Vw//  \w /  1  1  *J 

DO/CIN-CB/ 

JOHN  WALSH 

\J  V_/  1   1  1  VI    V  V  I  \  I  'S  1  1 

JAMES  ALEXANDER  CORP 

MP  BIOMEDICALS  LLC  SOLON  OH  -  EIRS  488S  RECALLS 

1 V  1  1       1  }  1  Vw/  1 V  1  1— —  IS  1  Vw/  /  \LU    L_  L_  Vw/  ,    Vw/  Vw/ 1_  Vw/  1  VI  ,    Vw/  1   1         1  III  V/  ,      i  *S  V/  V/  ,    1   1 1_  V/  /  \  L_  L_  V/ 

1/11  TO  PRESENT 

2013-200 

01/09/2013 
02/07/2013 

ORA/ 
ORA/ 

INGRID  S  MARTIN 
COLLORA  LLP 

AMERIDOSE  LLC  -  RAW  MATERIAL,  ENVIRONMENTAL  SPL 
TEST  RESULTS 

2013-201 

01/09/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

GRANUFLO,  NATURLYT  -  BLACK  BOX  WARNING,  RECALL 

02/07/2013 

\J C—l  \J  1  1  t—\J  1  \J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  1— /  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

CROSBY  T-5041 7  COURTNEY 

\w /  1  1  \s  *S  IS  1       1     Sw*  V/       1   /   .    v/  Vw/  \S  1  1  1  1  1  1   1 

RECS 

2013-202 

01/10/2013 
02/08/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Lena  Gomez 

Keller  and  Heckman,  LLP 

FDA  OPINION  LETTER  RE  MILK  PROTEIN  CONCENTRATE 

Page  209  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201  3-203 

01/10/2013 

\J  1  /  1  \JI  c—w  1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1  I— 1 1  \i  V_/ 1 V  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1  l—f  1  / 

Rarhpl  .lohnQon 

1  IQl^l   CI  UUI  II  IOUI  1 

MAREK  KUNECKI  LODZ  POLAND  -  483  MOST  RECENT 

IVI/\I  II  IV   l\UI  <ll  W  1  V  1  ,    1  Vw/  IS  l—  .    1    Vw/  1  1  \  1  h  IS       T^vJv/  1  V  1  V_/  \->  1     1  11  \J  I  IN  I 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2013-204 

01/10/2013 

W  1  /    1  Wl  L—W\W 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1 V  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  I  IS  I  1 

Rohprt  Ohprlpnripr 

1  IWWWI  I  v-'k/t/l  1  W  1  1 VJ  1 

SINEMET  SINEMET  CR  -  SBA 

Vw/  1  1  N  1  1  V 1  1       1  j    v_/  1  1  v  1  1 V  1  1— —  1     \  '  1  I        Vw/  L/  / \ 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \S  IS  1  1  1/  W  III    /  \S  I  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

Synthonics,  Inc. 

2013-205 

L—W   1  \J  C—W\J 

01/10/2013 

U  1/    1  Wl  L—W\\J 

02/08/2013 

FDA/OGROP/ORA/NE-FO/NYK- 

1    IS  1  \!  Vw/  \J  1  1  \S  1    1  Vw/  1  1/  V/  1  H  l__    1    Vw//  1  *l    1    1  \ 

DO/NYK-DCB/ 

1  pcijp  Paul 

1 —  t7oMC7    1  C1UI 

PERRIGO  CO 

ALTARIE  PHARMACEUTICALS  AOUEBOGUE  NY-EIR  483 

ML  1  #1 1  1 1  1— —    1     1   1 1  \  1  1 1  VI/  V  Vw/  1  kw7  1  1  UmLw  h    /  V  V«x  Vw/  1— —  1  f  \  '  Vwi  VwS  1  ^    1  vj    1          l_  II   1  ,        v/  V-/ 

(2/01/2010  -  01/08/2013) 

2013-206 

L—W    1  \J  L—WW 

01/10/2013 

Will  Wl  L.U  1  u 

02/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      II  \-S  IS  1  11   XI  \S  \S  1—  1  1/  1  /  1    \S  1/ 

AYA  NAGANO 

l  \  l  l  \   1  V|/ \V_>W VI  *J  v_/ 

KYOCERA  Medical  Corporation 

K1 20370 

1  V  I  L_  V_/  V/  /  W 

2013-207 

01/10/2013 
02/08/2013 

ORA/ 
ORA/ 

Loren  Larkin 
LARKIN,  LOREN 

ST  JUDE  MEDICAL,  SYLMAR,  CA  AND  SAN  JUAN,  PR  - 
RESPONSE  TO  483  (1 1/02/2012  -  01/09/2013) 

2013-208 

01/10/2013 

FDA/OC/OES/DFOI/ 

Jonathan  Zand,  PharmD 

APIXABAN  -  SBA 

02/08/2013 

WC—I  W\JI  L—W    I  \J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  1  1/  > — /  III    /  L/  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  V/  L/  1  1  1/  \S  III    /  \S  I  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

IJnTnDatp  a  div  of  Woltpr^  Kluwpr 
Health 

2013-209 

L—W    1  \J  L—WW 

01/10/2013 

W  l  1    l  Wl  L—W\W 

02/08/2013 

FDA/OF/CFSAN/OCD/EOS/ 

1    IS  1  \!  Vw/  1    /  Vw/  1    *s  J  \  \  N/  Vw/  Vw/  1  / ;  l_  Vw/  V-// 

.ludv  Npnlpv 
Valspar  Corporation 

FCN  635 

1    V/ 1  M  WW-*J 

2013-210 

01/10/2013 
02/08/2013 

OM/OMP/DODM/ 

ronald  piana 
Ronald  Piana 

IMMUNOLOGY  DEVICES  ADVISORY  PANEL  MEETING  - 
TRANSCRIPT  (12/09/1985) 

2013-21 1 

01/10/2013 

Will  Wl  C—W\\J 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      11  V/  L*s  1  1  1/  V_/  III    /  IS  I  IS  I  1 

iark  ruhin^tpin 

PROBENECID  -  APPROVAL  RECS 

1     1  l  >  '  l—f  1  1  .  1  \J  1  1  '        1  V 1     1     1  1 V  J  V  1  1 1       1  1 1  ^  '  '  I 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

UNIVERSITY  OF  CINCINNATI 

O  A  H  O  OHO 

AH  /H  A  /OA  H  O 

01/10/<;013 

rUA/Or/0rbAN/OGD/tOb/ 

Ryan  Simon 

rn|  IITA/CACTADI   CI    II  II^C  ^      1  ADIMr*       AOIMIAM  1  CI — r  [Z  H)  O 

rKUl  1  /V t(jt  1  ABLt  JUIOt  OOLOHINu  -  OPINION  Lt  1  1  tKb 

02/08/2013 

CANTOX  Health  Sciences 
International 

II  1  LVy  1  1  ICALIv/l  IUI 

AND  CORR 

2013-213 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Ketan  Parekh 

IND  18004,  NDA  019839 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Parekh,  Ketan 

Page  210  of  895 


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Total  Records:  9990 


Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


FDA/OMPT/CDER/ORP/DIDP/ 

2013-214 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Dustin  Block 

ANDA  200644  -  EFFECTIVE  APPROVAL  LETTER 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

IPD  Analytics,  LLC 

2013-215 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Marie-Hlne  Dancause 

VYVANSE  -  AERS 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UMr  I  /OUtrl/Urir/UIUrV 

pharmacist,  Hotel-Dieu  de  Levis 

20  \  3-2  \  6 

Hn  /OA  ^  O 

01/10/^013 

OVM/OOU/ 

Michael  Mlodzik 

ci  iitadii  i -r\/  nrTiTiAM  r\r»n  AOAA/OOI 

bUI  1  ABILI 1  Y  rt  1 1 1  ION  Oyr-OoUb/Crl 

02/08/2013 

OM/OMP/DODM/ 

Boehringer  Ingelheim  Vetmedica, 
Inc. 

2013-217 

01/10/2013 

FDA/OF/CFSAN/OCD/EOS/ 

RICHARD  C.  BADEAUX 

CREATIVE  COMPOUNDS  LLC,  SCOTT  CITY,  MO  -  EIR  1/15/10 

02/08/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

DEGAN  BLANCHARD  EL  AL 

MCTAI    AMTIIl^MV  IM  CTC\/IA  1  CAE  CYTDAPT 

Mb  1  AL  AN  1  IMUN  Y  IN  o  1  tVIA  LtAr  CA  1  HAL- 1 

2013-218 

01/10/2013 

FDA/OGROP/ORA/CE-FO/DET- 

TEDD  KESSLER 

STRYKER  TRIDENT  -  CEMENTLESS  CUPS,  POLYETHYLENE 

02/08/2013 

DO/DET-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

LAW  OFFICE  OF  TED  KESSLER 
PC 

SHELLS;  SECUR  FIT  MAX  STRYKER  STEMS  CMPLNTS, 
WARNING  LTR,  MDRS  2005  TO  PRESENT 

2013-219 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

AMITRIPTYLINE  -  AER 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HEUSTON  240731,  BRIAN 

2013-220 

01/10/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ELAVIL  -  AER 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

rUM/UIVIr  I  /uUtn/Unr/UlUr/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HEUSTON  240731,  BRIAN 

2013-221 

01/10/2013 

FDA/OC/OES/DFOI/ 

MORTON  GROVE  PHAMACEUTICAL  -  SELENIUM  SULFIDE 

02/08/2013 

ANDREWS  D1 7561,  JOHN 

LOTION;  PERRIGO  -  SELENIUM  SULFIDE  TOPICAL 
SUSPENSION 

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Subject 

2013-222 

01/10/2013 

CVM/OCD/ 

Michael  Mlodzik 

SUITABILITY  PETITION  2-P-0945-0001 

02/08/2013 

FDA 

OM/OMP/DODIW 

Boehringer  Ingelheim  Vetmedica, 
Inc. 

2013-223 

01/1 0/2013 

W  1  /    1  Wl  L—\J\\J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  \w/ 1  v  1 1      11  \  '  Lh'  1  1  1/  \w/  III    /  1 — '  I  IS  I  1 

Kptan  Parpkh 

MIRENA  -  IND  NDA 

1 V  1  1  1  1 1— —  1  N  1  \       l  1  *i  is  3    1  VI  IS  1  \ 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \J  \S  1  1  1/  V^/  III    /  ( — '  I  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

Parekh,  Ketan 

2013-224 

01/10/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

Rachel  Johnson 

INFLUENZA  VACCINE  -  VAERS 

02/08/2013 

ALFB/ 

FOI  Services,  Inc. 

2013-225 

01/10/2013 

Will  Wl  L—W\\J 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \w/  IS  1  1  1/  W  III    /  I — '  1  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

Kim  Cannnp 
Porzio  Life  Sciences 

SERAX  -  REGULATORY  LETTER  ISSUED  BY  THE  DIVISION 

Vw/  1  1  It  \/\        l  1 1_  K-A  \S  1  1  \  1  \S  III     1  1       1    1  1  1  I    ]  *S  \S  \S  1  IS    IS)  I       III  1        IS  1  V  1  ^w/  1  Vw/  1  v 

OF  ADVERTISING,  BUREAU  OF  DRUGS  (01/01/1975  - 
01/31/1975) 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      11  \  '  Lh'  1  1  1/  \s  III    /  1— /  1  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-226 

01/10/2013 

Will  Wl  L—\J\\J 

02/08/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  \s  1 V  1  1      11  \S  IS  1  11   11  W  \S  1—  1  1/  1 — /  1    \S  11 

Rarhpl  Johnson 

1   ICI*_'I  1      \   WW\  II  1  Jul  1 

FOI  Services,  Inc. 

DEEP  TMS  BY  BRAINSWAY  -  51  OK 

is  i  i  i       i  i  v  i       is  i    i  }  i  \  i  \  1 1  *j  \w/  v  v  i  \  i        j  i  ui  \ 

2013-227 

01/10/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Edward  McPike 

NUSKIN  -  APPLICATION  FOR  CLEARANCE  OF  A  FACIAL  SPA 

02/08/2013 

Stifel  Nicolaus  &  Co 

UNIT 

2013-228 

01/10/2013 
02/08/2013 

F  D  A/OG  ROP/O  RA/P  A-  FO/S  AN  - 
DO/SAN-CB/ 

ORA/OCI/ 

ORA/OCI/ 

PAMELA  BROOKS 

FIRST  RECORDS  RETRIEVAL 

REFUSE  OF  SINGLE  USE  ENDOCAVITY  NEEDLE  GUIDES 
RECS  1/10  TO  PRESENT 

2013-229 

01/10/2013 
02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

PAUL  W.  SHAW 
K&L  GATES 

NEW  ENGLAND  COMPOUNDING  CENTER,  FRAMINGHAM, 
MA  -  INVESTIGATION  RECS,  LAB  ANALYSES,  TEST 
RESULTS,  ETC  9/12  TO  10/12 

2013-230 

t—W  1  \J  C—\JW 

01/10/2013 

U  1/   1  Wl  L—W  l  \J 

FDA/OMPT/CDER/ORP/DIDP/ 

1       Lri/  /    V/   Vw/  1  v  1  1          1    /   *W»  Lh'  1         1     1/   \w/  III       /  1 — '  I  IS  I  1 

A  LUKE  SMITH 

1  \  i    1  KJ  1  \  1— —   \J  1  V 1  1  1  1  1 

ANDA  40-445  APRVL 

1  VI  ^1  IS  1  \       \J    ^X^X W  1  \  1     1   1  V  L- 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FARUQI  &  FARUQI  LLP 

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201 3-231 

01/10/2013 

\J  1  /  1  \JI  C-\J  1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

A  LUKE  SMITH 

1  \ .    1  Ul\l       wIVII  1  1  1 

ANDA  40-445  CROSS  DISP  RVW  SUMMARY  SUMMARY 

1  \  1  *J  L/ 1  \  ty  ttij  \J\  1V_/vJvJ   UIUI      1  IV  VV        \J  1 V 1 1 V  l/\  1  1  1  ,  UUIVIiVlrM  l  1 

02/08/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1     1  /  V/  l_>  1  1  1/  \y  III    /  l_/  1  i_y  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FARUQI  &  FARUQI  LLP 

RVW 

2013-232 

01/10/2013 
02/08/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S.  BARR 

JH  BARR  &  ASSOCIATES  LLC 

DAILY  LOG  12/24-28/12 

2013-233 

01/11/2013 

FDA/OGROP/ORA/SW-FO/DAL- 

Tara  J.  Myslinski 

HEALTHPOINT  -  CORR  RE  HP802,  ICX-SKN,  OASIS,  ETC 

02/11/2013 

DO/DAL-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

O'Connor,  Carnathan  &  Mack,  LLC 

2013-234 

01/11/2013 
02/11/2013 

OM/OMP/DODM/ 

Sue  Corbett 

THE  RESEARCH  INVESTMENT, 
INC. 

SPECIAL  REPORT  TO  FDA  PUBLIC  MEETING  ON  RE- 
EVALUATION  OF  RITODRINE  LABELING  (1992) 

2013-235 

01/1 1/2013 
02/11/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Don  Hammond 

Raymond  Paul  Johnson,  A  Law 
Corporation 

EMBASSY  SUITES,  LA  JOLLA,  CA  -  PERMITS,  COMPLAINTS, 
INSPECTION  RECORDS  ETC  (05/22/201 2  -  01/09/2013^ 

2013-236 

01/11/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Kayla  Conroy 

FOOD  ADDITIVE  PETITIONS  FOR  ARTIFICIAL  SWEETENERS 

02/11/2013 

Kayla  Conroy 

ETC 

201 3-237 

01/1 1/2013 

\J  1  /  1  11  C-\J  1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  [_/  1 1  '  1  / 

NDA019952  NDA019953  NDA01 8609  ETC  -  SBA 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Fresenius  Kabi  USA 

2013-238 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

F  DA/OG  ROP/O  RA/P  A-  FO/S  AN  - 
DO/SAN-CB/ 

Sarah  Geisert 
GENERAL  MILLS 

GENERAL  MILLS,  WEST  CHICAGO,  IL  -  EIR  06/10;  GENERAL 
MILLS,  LODI,  CA  08/10;  GENERAL  MILLS,  BELVIDERE,  IL  - 
EIR  10/11 

2013-239 

01/11/2013 
02/11/2013 

ORA/OCI/ 
ORA/OCI/ 

Christpher  Weaver 

THE  WALL  STREET  JOURNAL 

MEDIPLAN  HEALTH  CONSULTING,  RXNORTH.COM  - 
INVESTIGATION  RECS 

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Action  Office 

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Subject 

2013-240 

01/11/2013 

OC/OOPD/ 

HeeSun  Lee 

ANATIBANT  -  ORPHAN  PRODUCT  DESIGNATION 

02/11/2013 

F  D  A/OM  PT/OS  M  P/OO  P  D/ 

Aclairo  Pharmaceutical 
Development  Group 

2013-241 

01/11/2013 
02/1 1/2013 

FDA/OC/OES/DFOI/ 

Christopher  Weaver 

THE  WALL  STREET  JOURNAL 

MEDICAL  DEVICE  INOPERABILITY,  SECURITY, 
CONNECTIVITY  -  FOIA  REQUESTS  AND  STATUS  (01/01/201 1 
-01/10/2013) 

2013-242 

01/11/2013 
02/11/2013 

FDA/OC/OES/DFOI/ 

Christopher  Weaver 

THE  WALL  STREET  JOURNAL 

COUNTERFEIT  MEDICINES,  MISBRANDED  MEDICINES, 
UNAPPROVED  MEDICINES  -  FOIA  REQUESTS  AND  STATUS 
(01/01/2011  -01/10/2013) 

2013-243 

01/1 1/2013 

\J  1 1  1  1  /  t—\J  1  \J 

FDA/OC/OES/DFOI/ 

Ohri^tonhpr  Wpavpr 

V/  1  1 1  IOIUUI  1      1  IV^UVl/l 

MASIMO  CORP  COVIDIEN  PLC  MINDRAY  ETC  -  FOIA 

1 V  11 \\-/  1  1  v  1  Vw/    V/  V^/  III     ,    \w/  Vw/  v  1  1 — '  1  1  1  N    1     l_  V/  .    1 V  1  1  1  N  1 — /  1   1/  \  1     l_  1  V/        1    Vw/  1  /  V 

02/11/2013 

THE  WALL  STREET  JOURNAL 

REQUESTS 

2013-244 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

INTERNATIONAL  VITAMIN  CORP,  FREEHOLD,  NJ  -  483,  EIR 
(11/21/2011) 

2013-245 

01/1 1/2013 

\J  \  1  1  1  /  t—\J  1  \J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  1  \l  Vw/  1  v  1  1      I  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  L/  I  / 

Kfpnhpn  From 

\J  LUU  1  1  \j  III    1  V/  1  1  1 

NDA  022212  (DUREZOL^  -  MEDICAL  REVIEW 

1  M  I — /  /  \   \J  C—  t—  L—  1  C—    \  L/  VwV  1  1 1  £  \—S  1  /        1  v  1  1  Lw/  1  V/  /  V  L_   1  1  1       v  1  1      V  V 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Eyegate  Parmaceuticals,  Inc. 

2013-246 

01/11/2013 

ORA/OCI/ 

Christopher  Weaver 

INVESTIGATION  RECS 

02/11/2013 

ORA/OCI/ 

THE  WALL  STREET  JOURNAL 

2013-247 

01/1 1/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  l— /  1  l_/  1  / 

Rarhpl  Johnson 

1  IClVufl  lul   Uvl  II  IOUI  1 

NDA  203752 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  Vw/  L/  1  1  1/  V_/  III    /  (_/  1  ]  /  1  / 

FOI  Services,  Inc. 

2013-248 

01/11/2013 
02/1 1/2013 

FDA/OF/CFSAN/OCD/EOS/ 
OC/COS/OES/ 

V-/  V//  Vw/  Vw/  V — Vw/  1 —  \JI 

OC/COS/OES/ 

Alex  Morrell 

Columbia  Srhool  of  Journalism 

Vw/W  1  U  1  1  \KJ\  CA    <*—t\-f  1  IL"/I    KJ  1    UUUI  1  lul  1 0 1  1  1 

REGULATION  OF  DIETARY  AND  FITNESS  SUPPLEMENTS  - 
CAERS,  EMAIL,  MEMOS,  ETC 

2013-249 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

Michael  C.  Cotugno 
Cotugno,  Michael  C 

ANALYTICAL  RESEARCH  LABORATORIES,  OKLAHOMA 
CITY  OK  -  483  MOST  RECENT(08/01/2012  -  01/1 0/201 3^ 

 <  ll    l  ,   1  I  l  \         r  t  ' .  '   1  V 1     II 1  \J  1  IN  1  1  U  \JI  \J  1  /  i—  w  1  w       WI/IW  w  U  1 

O  A  H  O  OCA 

2013-250 

AH  /-I  ^  /OA  -1  O 

01/1 1/2013 

UO/UUrU/ 

1  1  _  _ ,  o  ■  ■  i*i  1   «  « 

Heebun  Lee 

DtXANABINOL  -  UKrHAN  UtbluNA  1  ION 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Aclairo  Pharmaceutical 
npwplnnmpnt  (nrnun 

1— ' t<  V  UIUI/I  1  1 V/ 1  11   Vw/  1  UUU 

2013-251 

01/1 1/2013 

\J  I  1    1    II  l —       1  U 

FDA/OMPT/CDRH/OCER/DFOI/ 

.lo^pnh  Thornp 

yj v/ o k/ 1  i    i  i  iv/i  k/ 

K993438,  K01 1110,  K042037  ETC 

02/11/2013 

FDA/OC/OES/DFOI/ 
FDA/OC/OES/DFOI/ 

Thorpe,  Joseph 

2013-252 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

GORDON  JOHNSTON 

HIKMA  FARM  -  DILTIAZEM  HCL  ANDA  202-651 ;  MYLAN  LLC 

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V_/UI  III Ul  tt 

Due  Date 

Signature/  Requester 

Qi  ihio^t 
OUUJtfOl 

02/1 1/2013 

\J  C-l   1    1  /  L.U  1  vJ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      1  /  W  l_/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

GORDON  JOHNSTON 

K-A  \— '  1  1 1  /  V  /  1  N    W  V  1 1   MM  \j  |  \_/  I  i| 

-  TOPOTFOAN  HCL  ANDA  201-166'  ONOO  THERAPIES  LTD 

1  Vw/  1     Vw/  1  1  \w//  V 1  *J    1   IWL  1  \  1  *•  1— / 1  \  L—  W  1       1  WW.    v_/  1  M  \J  \*r     1  1   II  1  l/\  1     II  v-»    1      1  !_/ 

FDA/OMPT/CDER/ORP/DIDP/ 

REGULATORY  CONSULTANTS 
LLC 

-  CYTARABINE  ANDA  201-784,  ETC  TENTATIVE  APRVL  LTR 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-253 

01/11/2013 

ORA/ORM/ 

JOHNATHAN  RICKMAN 

PHARMACEUTICAL,  BIOLOGICS,  MEDICAL  DVC  MFG,  CLNCL 

02/1 1/2013 

ORA/ORM/ 

FDA  NEWS 

TRIAL  FACILITIES  IN  AND  OUTSIDE  THE  US  -  483S  12/1- 
31/12 

2013-254 

01/11/2013 

FDA/OGROP/ORA/PA-FO/SEA- 

JOHNATHAN  RICKMAN 

PRECISION  INTERCONNECT  LLC  (CONNECTIVITY 

02/11/2013 

DO/SEA-CB/ 

FDA  NEWS 

MEDICAL),  WILSONVILLE,  OR;  ADVANCED  RENAL 

TECHNOLOGIES  INC  BELLEVUE  WA  -  483S  1 1/1 -30/1 2 

1  1  \J  1   1 1  IV  1  \w/        1  1  VJ    1  1           ;    1  '  1  1  1  1       V  U  1  5    V  V  1  \        TUU  V^J     1    1  /   1     WW/    1  t— 

2013-255 

01/11/2013 

FDA/OGROP/ORA/SE-FO/SJN- 

JOHNATHAN  RICKMAN 

INTEGRA  NEUROSCIENCES  PR  INC,  ANASCO,  PR  -  483S 

02/11/2013 

DO/SJN-CB/ 

FDA  NEWS 

11/1-30/12 

2013-256 

01/11/2013 

FDA/OGROP/ORA/SE-FO/ATL- 

JOHNATHAN  RICKMAN 

BECTON  DICKINSON  AND  CO,  WILSON,  NC;  BEAUMONT 

02/1 1/2013 

DO/ATL-CB/ 

i — r~\  A    It  1  1 — 1  A  /o 

FDA  NEWS 

PRODUCTS  INC,  KENNESAW,  GA;  DSM  PHARMACEUTICALS 
INC,  GREENVILLE,  NC,  ETC  -  483S  1 1/1-30/12 

2013-257 

01/11/2013 

FDA/OGROP/ORA/PA-FO/SAN- 

JOHNATHAN  RICKMAN 

ALEXZA  PHARMACEUTICALS  INC,  MOUNTAIN  VIEW,  CA; 

02/1 1/2013 

DO/SAN-CB/ 

i — r~\  A    It  1  1 — 1  A  /o 

FDA  NEWS 

NEVRO  CORP,  MENLO  PARK,  CA;  CLAREBLEND  INC,  RENO, 
NV,  ETC -483S  11/1-30/12 

2013-258 

01/11/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

JOHNATHAN  RICKMAN 

I  HEALTH  INC,  WINDSOR,  CT;  ARTHROSURFACE  INC, 

02/11/2013 

DO/NWE-CB/ 

FDANEWS 

FRANKLIN,  MA;  ANIKA  THERAPEUTICS  INC,  BEDFORD,  MA  - 
483  11/12 

tUu    1   1  i   1  t— 

2013-259 

01/11/2013 

FDA/OGROP/ORA/CE-FO/PHI- 

JOHNATHAN  RICKMAN 

PHOTOMEDEX  INC,  MONTGOMERYVILLE,  PA;  BIO-PHARM 

02/11/2013 

DO/PHI-CB/ 

FDA  NEWS 

INC,  LEVITTOWN,  PA  -  483S  11/1-30/12 

2013-260 

01/11/2013 

FDA/OGROP/ORA/NE-FO/NYK- 

JOHNATHAN  RICKMAN 

FOUGERA  PHARMACEUTICALS  INC,  HICKSVILLE,  NY;  NOVA 

02/1 1/2013 

DO/NYK-DCB/ 

FDA  NEWS 

HEALTH  SYSTEMS  INC,  UTICA,  NY;  QUANTUM  MEDICAL 

IMAGING  LLC,  RONKONKOMA,  NY,  ETC  -  483S  1 1/1-30/12 

2013-261 

01/11/2013 

FDA/OGROP/ORA/CE-FO/MIN- 

JOHNATHAN  RICKMAN 

CARMA  LABORATORIES  INC,  FRANKLIN,  Wl;  MODERN 

02/1 1/2013 

DO/MIN-CB/ 

FDA  NEWS 

PRODUCTS  INC,  MEQUON,  Wl;  NONIN  MEDICAL  INC, 
PLYMOUTH,  MN  -483  11/12 

2013-262 

01/11/2013 

FDA/OGROP/ORA/SE-FO/NOL- 

JOHNATHAN  RICKMAN 

VILEX  IN  TENNESSEE  INC,  MCMINNVILLE,  TN;  HEALTH 

02/1 1/2013 

DO/NOL-CB/ 

FDANEWS 

SCIENCE  PRODUCTS  INC,  HUEYTOWN,  AL;  AIONEX  INC, 
GOODLETTSVILLE,  TN,  ETC  -  483S  1 1/1-30/12 

2013-263 

01/11/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

JOHNATHAN  RICKMAN 

WATSON  LABORATORIES  INC,  CORONA,  CA;  EVOFEM  INC, 

02/11/2013 

DO/LOS-CB/ 

FDA  NEWS 

SAN  DIEGO,  CA;  RA  MEDICAL  SYS  INC,  CARLSBAD,  CA  - 

tOO    I    1/  IL 

2013-264 

01/11/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

JOHNATHAN  RICKMAN 

APTUIT  LLC,  HARRISONVILLE,  MO -483  11/12 

02/1 1/2013 

DO/KAN-CB/ 

FDA  NEWS 

2013-265 

01/11/2013 

ORA/ 

JOHNATHAN  RICKMAN 

ORION  CORP,  ESPOO,  FINLAND;  AARTI  DRUGS  LTD. 

02/11/2013 

ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA  NEWS 

MAHARASHTRA  STATE,  INDIA  -  483  1 1/12 

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Total  Records:  9990 


\_/UI  III Ul  tt 

Due  Date 

MOLIUI 1  WlllOti 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl u/  ricLjUtJoLci 

OUUJtfOl 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-266 

01/11/2013 
02/11/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

JHONATHAN  RICKMAN 
FDA  NEWS 

OMRIX  BIOPHARMACEUTICALS  LTD,  KIRYAT-ONO,  ISRAEL; 
VETTER  PHARMA  FERTIGUNG  GMBH  &  CO  KG, 
RAVENSBURG,  GERMANY;  DOMINION  BIOLOGICALS  LTD, 
DARTMOUTH,  CANADA  -  483  1 1/12 

2013-267 

01/11/2013 
02/1 1/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

TABERNA  PRO  MEDICUM,  LUENBURG,  GERMANY; 
FISIOLINE  SRL,  VERDUNO,  ITALY;  LINET  SPOL  SRO,  SLANY, 
CZECH  REPUBLIC  -  483  11/12 

2013-268 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

PHARMACEUTICAL  INNOVATIONS  INC,  NEWARK,  NJ; 
VECTRACOR  INC,  TOTOWA,  NJ;  BIPORE  MEDICAL  DEVICES 
INC,  NORTHVALE,  NJ,  ETC  -  483S  1 1/1-30/12 

201 3-269 

01/1 1/2013 

\J  1  /  1  1  /     V/  1  o 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1  v  1 1     1  /  \-/  1— /  1  1  1/       III    /  1— '  1 1— '  1  / 

MICHAEL  R  COHEN  RPH  MS  SOD 

IVIIV_/I   1 1  \  1  1       1  1    Vw/  VwX  1   II  1  M    1  11     II    1  V  1  v  *    W       1  ' 

MEDWATCH  RPTS  CODED  AS  MEDICATION  ERRORS  12/1- 

i v 1 1  i— /  v  v  i  \  \  \j i  i  i  1 1    i  VwJ  v/ \w/ 1  '  i  i  /  nu  i  vi  i  i  <  i  wn  i  i \_/ 1  m  i  i  1 1  iw  i  io   i  £_/  i 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INSTITUTE  FOR  SAFE 
MEDICATION  PRACTICES 

31/12 

201 3-270 

01/1 1/2013 

\J  1  /  1  1  /     V/  1  O 

02/11/2013 

FDA/OM  PT/CD  E  R/OR  P/D  1  DP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  1— /  1  L>  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

JOHNATHAN  RICKMAN 

vJWI  IIM/^  1  1  Iril  M    1  1 1  \J  1  \  1 V 1/*  1  M 

FDA  NEWS 

JIANGXI  TIANXIN  PHARMACEUTICAL  CO  LTD  LEPING 

u  ir\i  n             i  \ r\\  *i/\iin  i    i  i r  \ \  uvinwi  \j  i  i  v/ 1  \ i     v_/\_/  i     i  i_/.  i  i  i    ii  ivj, 

CHINA;  CHIA  Gl  LTD,  CHIOS,  GREECE;  GRISI  HNOS  SA  DE 
CV,  MEXICO -483  11/12 

2013-271 

01/11/2013 
02/1 1/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

KATH  KHEMICALS  LLC,  STERLING  HEIGHTS,  Ml;  STRYKER 
INSTRUMENTS,  PORTAGE,  Ml;  DEPUY  ORTHOPAEDICS  INC, 
WARSAW,  IN  -483  11/12 

2013-272 

01/11/2013 
02/1 1/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

DERMAZONE  SOLUTIONS  INC;  SAINT  PETERSBURG,  FL; 
AIG  TECHNOLOGIES  INC,  DEERFIELD  BEACH,  FL;  VALJEAN 
CORP,  INDIAN  HARBOUR  BEACH,  FL  -  483  1 1/12 

2013-273 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

NEXGEN  PHARMA  INC,  COLORADO  SPRINGS,  CO; 
CARDINAL  HEALTH  414  LLC;  DENVER,  CO;  PARKWAY 
PRODUCTS  INC,  LOVELAND,  CO  -  483  1 1/12 

2013-274 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

JOHNATHAN  RICKMAN 
FDANEWS 

RX  AIR  INDUSTRIES  LLC,  FARMERS  BRANCH,  TX; 
AMERICAN  AESTHETICS  MEDICAL  SUPPLY  INC,  DALLAS, 
TX;  OHM  PHARMACEUTICAL  INC  414  INC,  DALLAS,  TX  -  483 
11/12 

2013-275 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

FOREST  PHARMACEUTICALS  INC,  CINCINNATI,  OH;  HUNT 
BROTHERS  PRODUCTS,  ZANESVILLE,  OH;  SYNAPSE 
BIOMEDICAL  INC,  OBERLIN,  OH  -  483  1 1/12 

2013-276 

01/11/2013 
02/11/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

AMICUCCI,  PHYLLIS 

DR  SAUD  A  SADIQ,  MULTIPLE  SCLEROSIS  RESEARCH 
CENTER  OF  NEW  YORK,  NEW  YORK,  NY  -  CESSATION  OF 

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Total  Records:  9990 


Control  #        Reed  Date  /  Action  Office  Signature/  Requester  Subject 

Due  Date 


FDA/OMPT/CBER/OCOD/DDOM/ 

THE  STEM  CELL  TRIAL  RECS  2012 

A  1  CD  / 

ALrbV 

2013-277 

01/11/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 

JOHNATHAN  RICKMAN 

DANIELS  SHARPSMART  INC,  CHICAGO,  IL;  CORPAK 

02/11/2013 

DO/BLT-CB/ 

FDA  NEWS 

MEDSYSTEMS,  BUFFALO  GROVE,  IL  -  483  11/12 

FDA/OGROP/ORA/CE-FO/CHI- 

DO/CHI-CB/ 

2013-278 

01/11/2013 

ORA/ 

MARIA  MUNOZ 

FROZEN  PASTEURIZED  EXTRA  JUMBO  MARISSIMO  U-250, 

02/11/2013 

ORA/ 

SEADCO  USA  CORP 

EXTRA  JUMBO  SEADCO  U-1 30  ENTRY  #E4P-0022287-7  - 

1  flR  RCCI  II  TO 
1  i\ L_)  nLOUL  1  O 

201 3-279 

01/1 1/2013 

\J  1  /  1  If  C-\J  1  O 

FDA/OGROP/ORA/CE-FO/BLT- 

I   1  >  i\:  \w/     i  i  w  i  /  \_/ 1  in/  \_y  i      i  \_// 1  '  I   i 

JOHNATHAN  RICKMAN 

\J  W  1  IIN/^  1  1  Iril  M    1  I 1  \J  1 \l  Vl/^l  N 

CUSTOM  HEALTHCARE  SYSTEMS  INC  RICHMOND  VA' 

W  UvJ  1  V— '  1 V  1   1  1  1  /VI      1  1  1  W/\  1  1 1       v  '  1  v  '  1  1  1 VI  v  )   1 1  M  \J  ,    III  W  1  1 1  v  l\*s  1  M  1— /  ,    V  1  \  , 

02/1 1/2013 

\J t—l    1     1  /  L-\J  1  O 

DO/BLT-CB/ 

FDA  NEWS 

1    1  '  f  \  1  11  V  V  v  ' 

FUTREX  INC,  HAGERSTOWN,  MD;  UPM  PHARMS, 

BALTIMORE,  MD- 483  11/12 

2013-280 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ALAN  M  FELDMAN 

ALAUNUS  PHARMACEUTICAL  LLC  -  RECALLS,  CMPLNTS, 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FELDMAN  SHEPHERD  ET  AL 

I  rtMINo,  1 1  O  1/yo  1  U  rntotlN  1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

OC/OL/ 

2013-281 

01/11/2013 

OC/OM/OMP/DDM/ 

MARILYNN  WHITNEY 

DKT  FDA-2012-P-0904 

02/11/2013 

COVINGTON  BURLING  LLP 

2013-282 

01/11/2013 

FDA/OC/OES/DFOI/ 

DAILY  LOG  12/24-28/12 

02/11/2013 

FOI  Services,  Inc. 

2013-283 

01/11/2013 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 

DAILY  LOG  12/24-28/12 

02/11/2013 

DOMINION  GROUP  INC 

2013-284 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ALAN  M  FELMAN 

NEW  ENGLAND  COMPUNDING  PHARMACY  INC  -  RECALLS, 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FELDMAN  SHEPHERD  ET  AL 

UMrLIN  I  o,  VIULA  I  l\J\\  nr  I  o,  1 1  U  1/yo  1  U  rntotlM  1 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

FDA/OC/OES/DFOI/ 

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Total  Records:  9990 


V_/UI  III Ul  tt 

MO  LIU  1 1  WIMOU 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl  u/  lic^UtJoLoi 

OUUJtfOl 

Due  Date 

ORA/ 

ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/OL/ 

2013-285 

01/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ALAN  M  FELDMAN 

AMERIDOSE  LLC  -  RECALLS,  CMPLNTS,  VIOLATION  RPTS, 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FELDMAN  SHEPHERD  ET  AL 

ETC  1/95  TO  PRESENT 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OC/OES/ 

OC/COS/OL/ 

FDA/OC/OES/DFOI/ 

ORA/ 

ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — f  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \J  l—s  1  1  1/  W  III    /  1 — '  1  L-/  1  / 

OC/OL/ 

2013-286 

01/1 1/2013 

\J  1  /    1                      1  U 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 

Liun    i  /  vi  ii  uowi  *j           i  ii  i /  v i v 1 1 

CLOSED  FOI  REQUESTS  12/24-28/12 

02/11/2013 

CanReg,  Inc. 

Ul/  1  1 1  C-\J  1  O 

P.I  OSFD  FP)I  RFQIIFSTS  1  ?/?4-?R71  ? 

ULWO  I  l_/    I    W I    1  1 1  W-J  1  O  1  O    1  £./           £_(_>/   1  £— 

02/11/2013 

FOI  Services,  Inc. 

2013-288 

01/1 1/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

DAILY  LOG  12/24-28/12 

02/11/2013 

WOLTERS  KLUWER  LAW  & 

BUSINESS 

o/~n  o  non 

2013-289 

01/1 1/2013 

rUA/OO/Utb/UhOI/ 

UtBI  OOHtN 

OLOotU  rOI  KtUUtblb  12/24-28/12 

02/11/2013 

WOLTERS  KLUWER  LAW  & 

BUSINESS 

2013-290 

01/11/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 

DAILY  LOG  12/24-28/12 

02/11/2013 

CanReg,  Inc. 

2013-291 

01/11/2013 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

CLOSED  FOI  REQUESTS  12/24-28/12 

Page  218  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

02/11/2013 

FDA  WEBVIEW/FERDIC  INC 

2013-292 

01/11/2013 
02/11/2013 

FDA/OC/OES/DFOI/ 

GLADYS  B.  TONKIN 

Center  for  Regulatory  Services,  Inc. 

DAILY  LOG  12/24-28/12 

2013-293 

01/11/2013 
02/11/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  12/24-28/12 

201 3-294 

01/1 1/2013 

\J  1  /  1  If  C-\J  1  O 

02/11/2013 

FDA/OC/OES/DFOI/ 

JOHNATHAN  RICKMAN 

\J  W  1  IIN/^  1  1  Iril  M    1  I 1  \J  1 \l  Vl/^l  N 

FDA  NEWS 

DAILY  LOG  12/17-21/12 

\—t  1  \  1 1_  1     1  KJ  y^A     1  C—l    1  /     C—  \  1  It— 

2013-295 

01/11/2013 
02/11/2013 

FDA/OC/OES/DFOI/ 

JOHNATHAN  RICKMAN 
FDA  NEWS 

DAILY  LOG  12/24-28/12 

201 3-296 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  / V/  Vw/ 1 V  1 1      11  \J  LJ  1  1  1/  W  III    /  [_/  1  1— /  1  / 

Raj-hpl  .Inhn^nn 

1  1u<jI  lul  UUI  II  IOUI  1 

NDA21435 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  V  1  1       1  /  \w/  L*S  1       1    1/  \-S  III     /  1 — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2013-297 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

C  Hartill 

RTI  Biologies,  Inc 

MUSCULOSKELETAL  TRANSPLANT  FOUNDATION,  EDISON, 
NJ  -  483  (09/24/2012  -  12/31/2012) 

2013-298 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Chelsea  A.  Loughran 

ANTIVIPMYN,  ANTIVENIN,  ANTIVENOM  -  FORM  1571,  FORM 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CBER/OCOD/DDOM/ 
ALFB/ 

Wolf  Greenfield  &  Sacks,  P.C. 

1572,  ETC 

2013-299 

01/13/2013 

OC/OOPD/ 

HeeSun  Lee 

TISSUE  PLASMINOGEN  ACTIVATOR  -  ORPHAN  PRODUCT 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Aclairo  Pharmaceutical 
Development  Group 

DESIGNATION 

2013-300 

01/13/2013 
02/11/2013 

ORA/ORM/ 
ORA/ORM/ 

Joan  Stitt(UG2CD-16) 
MERCK  &  CO.,  INC. 

GLP  INSPECTIONS,  BIOEQUI VALENCE  LABORATORIES, 
ANALYTICAL  LABORATORIES  -  LIST  OF  INSPECTIONS 
2011-2012 

2013-301 

01/13/2013 
02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  V  '       1  1  1/  \w/  III    /  1— /  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Richard  W  fionnpllo 

1  1 1  v-/ 1  1  CI  1  \A    ili          w  1  1 1  1  \^  1 1  w 

Faruqi  &  Faruqi,  LLP 

BIOSANTE  PHARMACEUTICALS  LIBIGEL  DRUG 
DEVELOPMENT  PROGRAM  -  SPECIAL  PROTOCOL 
ASSESSMENT,  PHASE  II  CLINICAL  TRIAL  DATA,  PHASE  III 
EFFICACY  CLINICAL  TRIALS  ETC 

2013-302 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

BLA  103780/5121 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-303 

01/13/2013 

OC/OOPD/ 

HeeSun  Lee 

NIMODIPINE  -  ORPHAN  DRUG  DESIGNATION 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Aclairo  Pharmaceutical 
Development  Group 

2013-304 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Sina  Carlson 

BINOSTO  -  BIOEQUIVALENCE  STUDIES 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Carlson,  Sina 

2013-305 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Ralph  Harris 

TACROLIMUS,  CYCLOSPORIN  -  AERS 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SAMFORD  UNIVERSITY 

2013-306 

01/13/2013 

OC/OOPD/ 

HeeSun  Lee 

CYCLOSPORINE  -  ORPHAN  DRUG  DESIGNATION 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Aclairo  Pharmaceutical 
Development  Group 

2013-307 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/SW-FO/DEN- 
DO/DEN-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

TWINLAB  CORPORATION,  AMERICAN  FORK,  UT  -  483,  EIR 
(11/01/2011  -  12/20/2011) 

2013-308 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

NUTRO  LABORATORIES,  S  PLAINFIELD,  NJ  -  EIR  (01/15/2012 
-  02/28/2012) 

2013-309 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

NBTY  BOCA  RATON,  FL  -  483,  EIR  (09/15/2010  -  10/30/2010) 

2013-310 

01/13/2013 
02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDRH/OCER/DFOI/ 

Mark  Pregenzer 

Ronald  Reagan  UCLA  Medical 
Center 

OCUCOAT  -  APPROVAL  ORDER,  SUMMERY  OF  SAFETY 
AND  EFFECTIVENESS 

2013-311 

01/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

BLA  125104/33  -  SUPPLEMENTAL  APPROVAL 

02/11/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

INFORMATION 

2013-312 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

PHARMAVITE  LLC,  VALENCIA,  CA  -  EIR  (1 1/15/201 0  - 
01/01/2011) 

2013-313 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Leslie  Paul 
PERRIGO  CO 

NBTY,  BOHEMIA,  NY  -  483,  EIR  (02/01/2012  -  03/10/2012) 

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Control  # 

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Due  Date 

Action  Office 

Signature/  Requester 

Subject 

2013-314 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

Leslie  Paul 

PERRIGO  COMPANY 

CAPSULEWORKS,  BAYPORT,  NY  -  EIR  (02/10/2009  - 
03/25/2009} 

2013-315 

01/13/2013 

OC/OOPD/ 

HeeSun  Lee 

PROGESTERONE  -  ORPHAN  DRUG  DESIGNATION 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Aclairo  Pharmaceutical 
Development  Group 

2013-316 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

1  pcijp  Paul 

1—  YsOM^   1  QUI 

PERRIGO  COMPANY 

NBTY  MANUFACTURING  LLC  ANAHEIM  CA  -  EIR 
(06/01/2011  -07/31/2011) 

2013-317 

01/13/2013 

OC/OOPD/ 

Stephen  From 

DUREZOL  -  ORPHAN  DRUG  DESIGNATION 

02/11/2013 

FDA/OMPT/OSMP/OOPD/ 

Eyegate  Pharmaceuticals,  Inc. 

2013-318 

01/13/2013 

OC/OOPD/ 

HeeSun  Lee 

APOMORPHINE  HYDROCHLORIDE  -  ORPHAN  DRUG 

02/11/2013 

F  D  A/OM  PT/OS  M  P/OO  P  D/ 

Aclairo  Pharmaceutical 
Development  Group 

DESIGNATION 

2013-319 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

NBTY  LLC,  CARSON,  CA  -  EIR  (11/15/2010  -  01/05/2011) 

2013-320 

01/13/2013 
02/11/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

Leslie  Paul 

PERRIGO  COMPANY 

NBTY,  INC,  CARBONDALE,  IL  -  EIR  (10/10/201 1  -  11/10/2011) 

2013-321         01/13/2013  ORA/ 

02/11/2013  ORA/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

FDA/OGROP/ORA/PA-FO/SEA- 
DO/SEA-CB/ 

ORA/OCI/ 

ORA/OCI/ 


Gary  Wittenberg 

Baranov  &  Wittenberg,  LLP 


FLANDERS  PHARMACY,  CLACKAMAS,  OR;  PACIFIC 
FRONTIER  MEDICAL,  REDWOOD  CITY,  CA  -  TEST  RESULTS 


2013-322 


2013-323 


01/13/2013 
02/11/2013 
01/13/2013 
02/11/2013 


FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
OC/OOPD/ 

FDA/OMPT/OSMP/OOPD/ 


Michael  Priest 

Self  

Richard  W.  Gonnello 
FARUQI  &  FARUQI  LLP 


CARGILL,  INC,  DES  MOINES,  IA  -  REPORT  ABOUT  FOOD 
SAFETY  CONCERNS 

CHELSEA  THERAPEUTICS  INTERNATIONAL  -  ORPHAN 
DRUG  DESIGNATION,  SPECIAL  PROTOCOL  ASSESSMENT, 
FAST  TRACK  STATUS,  ETC 


2013-324 


01/13/2013 
02/11/2013 


FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 


Joan  Stitt  (UG2CD-16) 
MERCK  &  CO.,  INC. 


ZOLPIDEM  -  CLINICAL  TRIAL  DATA,  DRUVING  SIMULATION 
STUDIES 


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/"V  1  1  If 

Control  # 

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Action  Office 

Signature/  Requester 

Subject 

Due  Date 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

201 1-12*1 

01/13/2013 

\J  1  /    1  \JI  L-\J  1  vj 

FDA/OMPT/CDER/ORP/DIDP/ 

1    !  '  1  \i  Vw/ 1 V  1 1      1  /  v_/  1— /  1  1  1/  \y  III    /  l_/  1  l_/  1  / 

Pptpr  R  Rrpnnin  MD 

1     dCI     1  I.    LJI"3VJyill,  IVIIw/ 

ZOLPIDEM  -  AERS 

L  Vw/  1—  1     1  lw/  1— —  1 V  1        /  1 1  1  I  Vw/ 

op/1  i/?nn 

FDA/nMPT/nnFR/DRP/nmp/ 

r  vj  t\i  v_/ivi  n  i  /  o  i— /  r_  n/     i  \  i  /  i— /  i  i_/  i  / 

r^pntpr  fnr  thp  ^ti  irl\/  nf  Pmnathir1 

Vw/CIILOl    IUI    LI  IC  OLUUy  yJ\   L_.l  1  IIJCILI  llv/ 

FDA/nMPT/nnFR/DRP/nmp/ 

Therapy 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-326 

01/14/2013 

FDA/OF/CFSAN/OCD/EOS/ 

NESTLE  BENECALORIE  NUTRITIONAL  SUPPLEMENT  - 

02/12/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 

Doe  J 

MANUFACTURING  PROCESS 

DO/NWJ-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 

DO/ATL-CB/ 

2013-327 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L*/  /  V/  Vw/  1  v  1  1      11  \J  \—s  1  1  1/  Vw/  III    /  Lrif  1  lw/  1  / 

CARLO  CASSULO  MD 

V-/  1      \  1       l  l—  Vw/        Vw/  /      V  Vw/  Vw*  ' — /    l_  Vw/        1  V  1  lw/ 

NUEDEXTA  (DEXTROMETHORPHAN  HYDROBROMIDE  & 

1    N    Vw/   1            |w/   1            /  \      1      /      l       l    lw/   1            /  \      1       1      I  Vw/  1  V  1  1— —      1       1       1  Vw/   III           II  1      \  1     VJ         |        |        |       |w/  1       I  Vw/  1— '   1       I  Vw/  1  V  1   1    1  '    1   VJV 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

QUINIDINE  SULFATE)  CAPS  -  AERS  1/10  TO  PRESENT 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-328 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  /    V/   Vw/  1  V  1  1          If    \  '  lw/  1         |     1/   Vw/  III       /    lw/  |  lw/  |  / 

CARLO  CASULO  MD 

Vw/  1      \  1       l  l—  Vw/        Vw/  /      V  Vw/  Vw/   l—  Vw/        1  V  1  lw/ 

JAKAFI  (RUXOLITINIB^  -  AERS  1/10  TO  PRESENT 

\J  1  \  1  \l  \  1     1    l  1  l  Vw*  /  V  Vw/  L_  1  1   1  1  VJ  |  I  i  I        1  V  l_  1  I  Vw/     \  1    I  \J     1  Vw/    1     1  1 1  Vw/  1  1  VJ  | 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-329 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1          lw/  /      V/    Vw/  1  V  1   1             1     /    Vw/  |w/   1            1       1/    Vw/  III         /  lw /    1   lw/   1  / 

CARLO  CASULO  MD 

Vw/  1      \  1       l  l—  Vw/        Vw/  /      V  Vw/  Vw/   l—  Vw/        1  V  1  lw/ 

PONATINIB  -  AERS  1/10  TO  PRESENT 

1     Vw/ 1  VI  1  V  J  1  1  VI  1  l_J        /  V  l_  1  I  Vw/     1  /    1  \J     1  Vw/    1     1  1 1  \  INI 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-330 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  1    \!   Vw/  |  V  1  1          1    /  Vw/  |w/  1         1     1/   Vw/  III       /    lw/  1  lw/  1  / 

CARLO  CASULO  MD 

Vw/  1      \  1       l  l—  Vw/        Vw/  /      V  Vw/  Vw/   l—  Vw/        1  V  1  lw/ 

ENZALUTAMIDE  -  AERS  1/10  TO  PRESENT 

1  1  Vi  £.  /   \LU    1  '    » 1  V 1  1  lw/  1— —         V   \  1       1    1  Vw/      1  /    1  V/      1  Vw/    1      11  l_  Vw/  1— —  1  VI  1 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-331 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1          lw/  1      \!    Vw/  |  V  1   1             1     /    Vw/  |w/   1            1       1/    Vw/  III         /     lw/    1   lw/   1  / 

CARLO  CASULO 

Vw/  / \  1   ILW    Vw/  /  V  Vw/  Vw/  I—  Vw/ 

QSYMIA  fPHENTERMINE  &  TOPIRAMETE  ER^  CAPS  -  AERS 

V_X  Vw/   1    1 V  1  1  t   \    11      II  1  1  V|   |    I       |    1 1  V 1  1  1  VI  1         VA      1  Vw /  1      1  1    1/   llv  1  1— —   1    l_    1       1    I  1    Vw*  /  \  1      U         /   1 1_  1    I  Vw/ 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

1/10  TO  PRESENT 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-332 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

CARLO  CASULO  MD 

ABIRATERONE  -  AERS  1/10  TO  PRESENT 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ASCEND  CAPITAL  LLC 

FDA/OMPT/CDER/ORP/DIDP/ 

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Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-333 

01/14/2013 
02/12/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

SUSAN  PATE 

CARESTREAM  HEALTH  INC 

RIVERAIN  MEDICAL  GROUP  -  SOFTVEIW  SYS  K092363 

2013-334 

01/14/2013 
02/12/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

FRANK  E  EPPERSON  DDS 

HYPODERMIC  SYRINGE  -  GRANDFATHER  DETERMINATION 
DISPOSABLE  CARPULE 

2013-335 

01/14/2013 
02/12/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

JUSTIN  LOVELACE 
TELEFLEX  MEDICAL 

PALL  MEDICAL  -  PALL  UTIPOR  ANESTHESIA  BREATHING 
CIRCUIT  SYS  K013093 

2013-336 

01/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

WILLIAM  SARRAILLE 

ST  JUDE  -  RESP  TO  483,  SUBMISIONS  7/1/12,  10/2/12 

02/12/2013 

ORA/ 
ORA/ 

SIDLEY  AUSTIN  LLP 

2013-337 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

JASON  MAHON 
PREMIER  ORGANICS 

PREMIER  ORGANICS  -  NOTES,  SUMMARIES,  WARNINGS 
LTRS,  ETC  1/07  TO  11/1/12 

2013-338 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

KURUME  UNIVERSITY,  KURUME,  FUKUOKA  PREFECTURE, 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MEROLA,  ERIC 

JAPAN  -  REC  1988 

2013-339 

01/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

AMBIEN  -  AERS 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UMr  I  /L/Utri/UrSr/UIUrV 

Doe  J 

2013-340 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 

STACY  L  CESLOWITZ 
SCHOEMAN  UPDIKE  &  KAUFMAN 

1  1  D 

LLr 

MARLYN  NUTRACEUTICALS  INC  -  IMMUNE  SYSTEM 
SUPPORT  LEMON  LIME  TABS  RECALL  FDA  SITE  VISIT  RECS 
1988 

2013-341 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/OGROP/ORA/NE-FO/NYK- 

UU/N  Y  IVUL/b/ 

STACY  L  CESLOWITZ 
SCHOEMAN  UPDIKE  &  KAUFMAN 

1  1  D 

LLr 

MARLYN  NUTRACEUTICALS  INC  -  IMMUNE  SYSTEM 
SUPPORT  ORANGE  TABS  RECALL  RECS  8/17/10 

2013-342 

01/14/2013 
no/1  o/om  q 

FDA/OF/CFSAN/OCD/EOS/ 

rUA/UbnUr/Un/VNt-rU/N  Y  r\- 

DO/NYK-DCB/ 

STACY  L  CESLOWITZ 

oOHULIVIAN  Ur Ulrxt  ot  r\AUrlVIAI\l 

LLP 

MARLYN  NUTRACEUTICALS  INC  -  AIR  SHIELD  PINK 
GRAPEFRUIT  TABS  RECALL  RECS  8/17/10 

2013-343 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

STACY  L  CESLOWITZ 

SCHOEMAN  UPDIKE  &  KAUFMAN 
LLP 

NBTY  ACQUISTION  LLC  (LEINER  HEALTH  PRODS  INC  )  -  AIR 
SHIELD  ORANGE  TABS  RECALL  RECS  8/17/10;  MARLYN 
NUTRACEUTICALS  INC  -  AFOREMENTIONED  TABS  COMM 

2013-344 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 
FDA/OGROP/ORA/NE-FO/NYK- 

STACY  L  CESLOWITZ 
SCHOEMAN  UPDIKE  &  KAUFMAN 

NBTY  ACQUISTION  LLC  (LEINER  HEALTH  PRODS  INC)  - 
AIRHEALTH  ORANGE  TABS,  AIR  PROTECTOR  ORANGE 

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Signature/  Requester 

Subject 

DO/NYK-DCB/ 

LLP 

TABS,  AIR  SHIELD  ORANGE  TABS,  ETC  RECALL  RECS 
8/17/10;  MARYLN  NUTRACEUTICALS  INC  - 
AFOREMENTIONED  TABS  COMM 

2013-345 

01/14/2013 
02/12/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

STACY  LL  CESLOWITZ 

SCHOEMAN  UPDIKE  &  KAUFMAN 
LLP 

NBTY  ACQUISTION  LLC  (LEINER  HEALTH  PRODS  INC)  - 
WALBORN  LEMON  LIME  STICK  PACK,  AIRHEALTH  LEMON 
LIME  STICK  PACK  RECALL  RECS  8/17/10;;  MARLYN 
NUTRACEUTICALS  INC  -  AFOREMENTIONED  TABS  COMM 

2013-346 

01/14/2013 

no/1  0/0(11'! 

F  D  A/0  F/C  FS  AN/OC  D/EOS/ 

rUn/Uunur/Unn/INL  rU/IN  I  i\ 

DO/NYK-DCB/ 

STACY  L  CESLOWITZ 
LLP 

NBTY  ACQUISSTION  LLC  (LEINER  HEALTH  PROD  INC)  - 
AIRHEALTH  LEMON-LIME  TABS,  AIR  PROTECTOR  LEMON- 
LIME  TABS,  AIR  SHIELD  LEMON-LIME  TABS  RECALL,  ETC 
RECS;  MARLYN  NUTRACEUTICALS  INC  - 
AFOREMENTIONED  TABS  COMM 

2013-347 

01/14/2013 

V/  1  /   1  TV  i—  W  1  O 

ORA/ 

CMPLNT 

V  /  1  V  1 1     1  1  N  1 

02/12/2013 

ORA/ 

Doe  J 

2013-348 

t—\J  1  \J  v-/  i  V/ 

01/14/2013 

U  1  /    1  TV  L—\J\\J 

02/12/2013 

FDA/OGROP/ORA/PA-FO/SAN- 
DO/SAN-CB/ 

PAUL  B  CALLAHAN 

i  nuL  i  >  v_/ 1  \ i  i  ni  ini  i 

CHARLES  RIVER  LABS 

NOVARTIS  VACCINES  &  DIAGNOSTICS  INC  EMERYVILLE 

1  N  Vw/  V  i  V  1  I  1  1  V/     V  1  \  v/  Vw/  1 1  M  1  vj    LX    !_/  InU  1  4  V  >  vJ  1   1  WO    1 1  MV_S  .    1  Ivll  1  1  1    V  ILLI  . 

CA-483S  7/7-15/10 

2013-349 

01/14/2013 

W  1  /   1  TV  L.U  1  U 

02/12/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \  '  1  }  1—  I  \I  \—s  \S  \S  IS  1  1 — /  1 — ^  Vw /  1 V 1/ 

ALFB/ 

PAUL  B  CALLAHAN 

i  r\ui-  i— *  v/ni  i  ni  inn 

CHARLES  RIVER  LABS 

GLAXOSMITHKLINE  BIOLOGIS  DRSDEN  GERMANY  -  483S 

\^Al  1  \/\  Vw/  V/  Ivll  1  1   1  1  \  1  1  1  N  I        \—}  1  Vw/  1  WV^Iw,    l_/ 1  \\J  L_ i  1  IN,          1  1  IIVI/\I*I   1  TUwU 

6/14-22/11 

2013-350 

01/14/2013 

FDA/OGROP/ORA/SE-FO/SJN- 

PATRICIA  SABATINI 

MYLAN  INC  -  WARNING  LTR  RECS  11/9/12,  10/13/11 

02/12/2013 

DO/SJN-CB/ 

PITTSBURGH  POST-GAZETTE 

2013-351 

01/14/2013 

Will  TV  L.U  1  U 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  l_/  1  1  1/  W  III    /  !_/  1  l_/  1  / 

REMERON  WELLBUTRIN  GEODON  -  MED  WATCH  RPT 

1  1 1  1 V  1  1— —  1  1  V_/  1  v  ^    V  V  1  1  l_  1  )  V_/  1  1  1  1  1  M  ^    Vw^  1  Vw/  1  /  v_/  IN        1  v  1  1— —  l — '     V  V  /  \  1  Vw/  1   1    1  1 1  1 

02/12/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2013-352 

01/14/2013 
02/12/2013 

ORA/ 
ORA/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

SAMANTHA  MYERS 

ROANOKE  TRADE  SERVICES  INC 

SBL  GLOBAL  INC  -  ENTRY  NUMBER  WUG-0151 1467,  WUG- 
01504843  NOTICES  OF  ACTION,  COMMERICAL  INVOICES, 
BILLS  OF  LADING,  ETC 

2013-353 

01/15/2013 

U  1  /    1  \JI  L—\J\\J 

02/13/2013 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Davirl  Flrlpr 

Uu V  IU   1  IUCI 

Parexel  International 

FOIA  REOUEST  LOG  (07/01/2011  -01/14/20131 

1    Vw/  in    1  1 1  \j(  V_/  1  V  '  1     Lv/vJ      1  U  1  /  V/  \  I  C—\J  1    1         Wlil  TV  L—\J\\Jj 

2013-354 

01/15/2013 
02/13/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Kristan  Phillips 
MacroGenics 

LONZA,  PORTSMOUTH,  NH  -  483,  EIR  (01/01/2010  - 
12/31/2010) 

2013-355 

£ —  V/   1  v/  v/\_/\_/ 

01/15/2013 

V/     1  /      1    \_//  L —  V/     1  V/ 

FDA/OMPT/CDER/ORP/DIDP/ 

Garv  Wolff 

u  i  y    v  ■  v/ 1 1 1 

ISR  6786292,  6806987,  6810329,  ETC 

02/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHIRE  PHARMACEUTICALS  INC 

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01/15/2013 
02/13/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Alison  Sathe 
Ellman  Intnernational 

K040563 

2013-357 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  J  /  I  / 

Cvnthia  Wntt?i97Pk 

BLA  1 03705/5332 

\—J  i—l  \      1  \J\J  l  \J  v//  v/  V/  V/  L— 

02/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRISTOL-MYERS  SQUIBB 

2013-358 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  I — '  1  J  /  1  / 

Frir  H  Wpinhprn  F^n 

PRADAXA  -  SUBMISSIONS  CORR 

1     1  1 1  \  1 — '  1  \  /  \  1  \        V_/  Vw/  lw/ 1  v  1  1  U  V_/  1  Vw/  1  VI  O  .    Vw/  Vw/  1  1 1  l 

02/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Firm  of  Eric  Weinberg 

2013-359 

01/15/2013 
02/13/2013 

FDA/OMPT/CTP/OD/ 

John  Shoemaker 
Visium 

ASSESSMENT  OF  THE  IMPACT  OF  MENTHOLATED 
CIGARETTES  ON  SMOKING  INITIATION,  DEPENDENCE,  AND 
CESSATION 

2013-360 

01/15/2013 
02/13/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Kpvin  Frip*% 

I   \  \J  VIII      \J  all    1  \w»  O 

COSMETIC  INGREDIENT  REVIEW 

VOLUNTARY  COSMETIC  REGISTRATION  PROGRAM 

V  Vw/  1  1  *J   1  /  \  1  1  1     V/  Vw/  V_/  1  V 1  1       1  1  \j    1  1 1  1  \J  1  1  1 1  \  1   1  Vw/  1  *J    1     1  1  Vw/  \Si  1  l  /  VI V  1 

UPDATE  (01/14/2012  -  01/14/2013) 

2013-361 

01/15/2013 
02/13/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  \w/  1  v  1  1      11  \J  l—s  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

Rphpppa  Shplburnp 

1   l  C7  KJ  t7  Vj  Vj  CI   VJ  1  I^IUUI  1  1 1» 

Ellipse  Technologies,  Inc. 

K971 783 

2013-362 

01/15/2013 
02/13/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Alan  Rappeport 
FINANCIAL  TIMES 

HERBALIFE  PRODUCTS  -  AERS 

2013-363 

01/15/2013 
02/13/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Thomas  M.  Burton 

THE  WALL  STREET  JOURNAL 

FDA  CHINA  AND  INDIA  OFFICES  -  CORR  RE  INSPECTIONS, 
SAFETY,  AND  COMPLIANCE  OF  DRUG  OR  API  FACILITIES  IN 
CHINA  AND  INDIA 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

OC/COS/OES/ 

V-/  V_//  Vw/  Vw/  V — \_/  | —  Vw// 

OC/COS/OES/ 

ORA/ 

ORA/ 

2013-364 

01/15/2013 
02/13/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

KYPER,  CHARLES  H 

MED-KHAN  (USA)  INC  -  LIPOKIT  WITH  DISPOSABLE  50CC 
AFT  SYRINGE  K083455 

2013-365 

01/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    i  / 1  \!  Vw/ 1  v  1 1      1  /  V/  lw/  1  1   if  V_/  III    /  1— /  1  ]  /  1  / 

GABAPENTIN  NEURONTIN  300MG  -  AERS 

V_^  /  V  l— J 1  \  1     1  1  N   1   1  1  <l  *    1  VI  1— —  Vw/  1  I  Vw/  |V|  |  ||VI    iJL/V/IVl  Vwi        /  V 1  1  I  Vw/ 

02/13/2013 

V/  £_/     1  V/  /  L —  V/    1  V./ 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

2013-366 

01/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

RAYMOND  M  DAVID  PHD 

D  &  C  RED  NO  9  ENTRY  #237  IN  CL  NO  1 5585  -  TOXICITY 

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□nor  v_*v_/iii 

STUDY 

2013-367 

01/15/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 

no  PHOEBE  MOUNTS  ESQ 

L*S  III     II  Vw/  l_  \  >  l_    1  V 1  Vw/  V/  1  M  1  K-S    \—  V/  \j 

MUSCULOSKELETAL  TRANSPLANT  FOUNDATION  -  483 

1 V  1  V/       V/  \J  L_  Vw /  V/  1  \  1— —  1  l_  1  1  \  \         1  1  l  /  \  1  >l  V/  1     1  /  \  INI     1    Vw/  V/  1     L/  /  V  1  1  V-/  1  v          i^  V/  V-J 

02/13/2013 

DO/NWJ-CB/ 

MORGAN  LEWIS  X  BOCKIUS  LLP 

1  V  1  ■ — /  1  I V^l  1  \  1  *J   L  1      VV  IU  VX  U\^V/l\IUv/  1  1  1 

12/12 

2013-368 

01/1 5/2013 

FDA/OGROP/ORA/CE-FO/PHI- 

CATERINA  GULYAS 

V_/ 1  \  1  1  1  III  M/  \  Vw/  V/  l_  I  r\U 

BIO-PHARM  INC  LEVITTOWN  PA-EIRS  483S  CO  RESP 

l—/  1  Vw/    1     1   11  VI  1 1 V 1    1  1  *l  V/  ,    1  1       VII     1  V_/  V  V  1  N  ,    1     /  \        l_  1  1  I  \^/  .        V/  V/  VJ  •    V/  Vw/    1  1 1  V/  1 

02/13/2013 

\J  t—l  1  \jl  C—\J  1  O 

DO/PHI-CB/ 

GXW  LABORATORIES  INC 

vjuvv   i  i  \  \  )  v»/ 1  \r\  \  w  i  ill  v  i  ii 

LAST  6  MONTHS 

01/1^72013 

\J  1 1  1  O/  C-\J  1  O 

FDA/OGROP/ORA/r.F-Fn/MIN- 

\_//  \  i  I  I  1 1 1  <J  f  \  \J  lj  l_  l  no 

COUNTY  1  INF  PHARMAP.FI  ITIHAI  S  1  1  C.  RRDDKFIFI  D  Wl  - 

v_/ v_/ k_/ 1 nj  i  i   i_iinl_  rnnnivinutu  i  i v//\ i_o  i_l_v/,  lj i  i *-_/»«_/ 1 \ i  1 1  i  i_^ ,  vvi 

AO  Hf)  /OA  ^  o 

0<;/ 13/^013 

DO/MIN-CB/ 

/^0\A/  1    ADADATADICC  IMP 

EIRS,  483S,  CO  RESP  LAST  6  MONTHS 

2013-370 

01/15/2013 

FDA/OGROP/ORA/PA-FO/SAN- 

ANDREA  SESSIONS  ESQ 

ABBOTT  LABS,  ABBOTT  DIABETES  CARE  -  GLUCOSE  TEST 

An  / a  o  /OA  ^  O 

DO/SAN-CB/ 

FHtUtKIOK  W  bMI  1  H  JH  LAW 

STRIP  RECALL  12/22/10,  CMPLNTS,  CORR,  ETC 

FnA/nMPT/nnRH/nnFR/nFDi/ 

FDA/OC/OES/DFOI/ 

OA  H  O    O  "7  H 

2013-371 

01/15/2013 

FDA/OF/CFbAN/OCD/EOb/ 

\S^.\    1    1    HI  IMI  AO 

KELLI  DUNLAP 

HALODROL  LIQUIGELb  -  RECAL  RECb 

AO  14  O  /OA  H  O 
02./  1  3/2.0  I  O 

FUA/UGKOP/UKA/NE-rU/NWE- 

KtKL>bMAI-i  &  rtL  1  Ub  PLLC 

DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    L/  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V/  III    /  1— '  1  L_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

rUA/UlvIr  1  /GUhK/OKr/UIL)r/ 

i —  r~ \  a  //""v/~*  n  /~\  n  //~v  n  a  //"■>  i —  i — /"~v  /k  ha/  i 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

L/  v_»/  |  v|  Vvu    V/  U/ 

O  A  H  O    O  ~7 O 

2013-372 

/4  C  /O  A  H  O 

01/15/2013 

ORA/ 

l\    1/"*  LI  A  IZ  1      1  \A/iNiizn  roA 

MICHAEL  J  WINER  ESQ 

iMni\/ini  iai    n i —  /~» o 

INDIVIDUAL  RECb 

02/13/2013 

ORA/ 

MICHAEL  J  WINER  LAW  OFC 

FDA/OGROP/ORA/SE-FO/FLA- 

r-\  /~\  / 1 —  1    a    /"■>  r~)  / 

DO/FLA-OB/ 

i —  r~\  a  //™v/~*  n  /""\  n       n  a  /o  i —  i — /*"\  /i —  i  a 

FDA/OGROP/ORA/SE-FO/FLA- 

DD/FI  A-HR/ 

L/V«_y/  1    1  r\  V_/ [_>/ 

2013-373 

01/15/2013 

ORA/ 

MANUEL  A  MOLINA 

FROZEN  SHRIMP  ENTRY  #MWCU6099637  -  CORR,  RPTS, 

A  A  14  4  /OA  4  O 

04/1 1/2013 

ORA/ 

■ —  ni —  i —  i  mi  ■    i  i /~v /-V  a  m  o  m  a  u  ft  nn 

FREEHILL  HOGAN  &  MAHARR 

TESTING,  ETC 

FDA/OGROP/ORA/NE-FO/NYK- 

LLP 

nn/NYK-nr.R/ 

L/  \j  i 1  >j  i  r\  \_j v/ 1_)/ 

2013-374 

01/15/2013 

\J  1  /   1  v//  £_  V/  1  O 

FDA/OC/OES/DFOI/ 

1    L/  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  L/  1    Vw/  1/ 

A  LUKE  SMITH 

I  \   l_  V/  1  V  1        K-S  1 V 1  1  1  1  1 

ANDA  40-445  -  APRVL  RECS 

1  VI  N  L/V  \       V/            v/        /  \  1     1  I  V  L_    1  1  L_  Vw/ \w/ 

02/13/2013 

FARUQI  &  FARUQI  LLP 

2013-375 

01/15/2013 

FDA/OGROP/ORA/SE-FO/ATL- 

CMPLNT#120110 

02/13/2013 

DO/ATL-CB/ 

GISSENDANNER,  ROBIN 

2013-376 

01/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

JENESSA  G  B  COCCARO 

GASPARI  NUTRITION  INC  -  NOVEDEX  XT  INVESTIGATION, 

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02/13/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

KERObMAR  &  FELTUb  PLLC 

RECALL  RECb,  TRANb,  ETC 

DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  \w/ 1 V  1  1      11  W  l_/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

2013-377 

AH  /H  C  /OA  H  O 

01/15/2013 

FDA/OF/CFbAN/OCD/EOb/ 

JENEbbA  G  B  COCCARO 

/—\  a  o n  a  ni  Nil  i~rn it i i  i k ^  a  /*^ n  i i —  t  nn~ro    k  i/*^~ri r~ o 

GAbPARI  NUTRITION  INC  -  M-ONE-T  RPTb,  NOTICEb, 

AO  M  O  /OA  ^  o 

FUA/UuKUP/UKA/NE-rU/NWE- 

KtKObMAK  &  rEL  1  Ub  PLLO 

MINS,  ETC 

DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  \J  1— •*  1  1  1/  V-/  III    /  l_/  1  1— /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

O  A  H  O    O  ~7  O 

2013-378 

01/15/2013 

FDA/OF/CFbAN/OCD/EOb/ 

JENEbbA  G  B  COCCARO 

r^.  a  o  n  a  ni  kii  i  ~f  n  it  i       i  i  k         <^~\  roAOTA  i —  nnTO   th  amp 

GAbPARI  NUTRITION  INC  -  ORAbTA  E  RPTb,  TRANb, 

02/13/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

i/ 1 —  n o r  a  a  n  o  i —  i —  i  ~r i  io  ni  i 

KERCbMAR  &  FELTUb  PLLC 

NOTICES,  ETC 

DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/nKAPT/nnFR/DRP/ninp/ 

n  \—jf\/  v_/ivi  n  i  /  \_/  is  r__  rv  v-/ n  n  / 1_/ 1 1_/ 1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

O  A  H  O    O  "7  A 

2013-379 

AH  /H  C  /OAH  O 

01/15/2013 

FDA/OF/CFbAN/OCD/EOb/ 

JENEbbA  G  B  COCCARO 

GAbPARI  NUTRITION  INC  -  OXAVAR  RPTb,  NOTICEb, 

AO  /H  O  /OA  H  O 

02/13/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

i/ 1 —  n o r  a  a  n  o  i —  i —  i  t-i  io  ni  i 

KERCbMAR  &  FELTUb  PLLC 

TRANS,  ETC 

DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FnA/OMPT/nnFR/DRP/nmp/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/CE-FO/NWJ- 

DO/NWJ-CB/ 

2013-380 

01/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

JENESSA  G  B  COCCARO 

GASPARI  NUTRITION  INC  -  ORASTAN  A  RPTS,  TRANS, 

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DO/NWE-CB/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

KERCSMAR  &  FELTUS  PLLC 

NOTICES,  ETC 

2013-381 

01/15/2013 
02/13/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

CAERS  159461 

2013-382 

01/15/2013 
02/13/2013 

FDA/OF/CFSAN/OCD/EOS/ 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

CAERS  159486 

2013-383 

01/15/2013 
02/13/2013 

FDA/OF/CFSAN/OCD/EOS/ 

a  iv  i i —  i   a  ou \/~r i_i 

ANGELA  SMYTH 

IOVATE  HEALTH  SCIENCES 
INTERNATIONAL  INC 

CAERS  159218,  160158 

2013-384 

01/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

MICHAEL  R  SNEBERGER  ESQ 

HBI  INTERNATIONAL  -  905J  RPTS  SE0001698,  SE0002348, 

02/13/2013 

FDA/OMPT/CTP/OD/ 

HBI  INTERNATIONAL 

SE0002350  ETC 

2013-385 

01/15/2013 
02/13/2013 

FDA/OC/OES/DFOI/ 

Amy  Kincanon 

LexisNexis  CourtLink  Document 
Retrieval 

2012-8911 

2013-386 

01/15/2013 
02/13/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  \w/  L/  1  11   1/  VwS  \— /  1— —  1  1/  1 — /  1    Vw/  J/ 

Art  Rankin 

I  \  1  L    1  lul  1  IMO 

Art  Rankis 

K1 20306 

2013-387 

01/16/2013 
02/14/2013 

OC/OM/OMP/DDM/ 

JEFF  GERTH 
PROPUBLICA 

DKT  1977N-0094 

2013-388 

01/16/2013 
02/14/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

Trevor  C.  Sanders 
AARON  J.  PRISBREY,  P.C. 

CODMAN  DURAL  GRAFT  IMPLANT  -  MEMOS,  REPORTS, 
STUDIES,  ETC 

2013-389 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  V-/  V/  l__  1  1/  1  /  1    Vw/  1/ 

Rarhpl  Johnson 

1  lClV.fl  lul   UUI  II  loul  1 

FOI  Services,  Inc. 

K123194 

1  V  I  C—  \J  1  \J  l 

2013-390 

01/16/2013 
02/14/2013 

ORA/ORM/ 

Vw /  1  1  / \/  Vw/  1  1 1 V  1  / 

ORA/ORM/ 

1  pp  Ann  1  i^^ 

LUu   1  V 1  II  1  LIOO 

AbbVie 

BIORESEARCH  MONITORING  -  LIST  OF  DOMESTIC  AND 

l— J  1  V_/  1  1 1_  V/  l_  I  \  1  l  V/  1   1    1 V 1  Vw/  1  N  1  1  Vw/  1  1 1  1  V  \Si        1  1  \J  1     Vw/  1      L*s  V-/  1  V 1  1  V/  1  1  V-/  nl  N  L/ 

INTERNATIONAL  INSPECTIONS  (01/02/2001  -  12/31/2012) 

2013-391 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Scott  Conlin 
N/A 

K1 02342,  K1 20563 

2013-392 

01/16/2013 
02/14/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Kathy  Lee 
General  Mills,  Inc. 

FOOD  GMP  MODERNIZATION  WORKING  GROUP:  SUMMARY 
OF  FOOD  RECALLS;  ANALYSIS  OF  FOOD  RECALLS 
INITIATED  IN  2008-2009  BY  AN  FDA  CGMP  WORKING 
GROUP 

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2013-393 

01/16/2013 
02/14/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

PARAXEL,  LOWELL,  MA  -  EIR,  483  (01/01/09  TO  PRESENT) 

2013-394 

01/16/2013 
02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  V  1  1       1  /  \w/  L*S  1       1    1/  \-S  III     /  1 — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Nanrv  Oiiindpr^on 

i  iui  iv^y            uci  oui  i 

Veritox 

FDA  GUIDELINES  FOR  REPRODUCTION  STUDIES  FOR 

1  1— / 1      \        Vw1   Vw/    |    1  /   1            1          |   |     *J   l_  \J        |         Vw/   |       I        |       I   1            |           11  Vw/   L/   V_/   Vw/      |       |  Vw/  1     V|        Vw/      |       lw/    1  /   1  1— —  Vw/        1         Vw/  1  I 

SAFETY  EVALUATION  OF  DRUGS  FOR  HUMAN  USE 

2013-395 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  1— '  1  11   1/  V_/  w  l_  1  1/  1 — /  1    Vw/  1/ 

William  Fi^hpr 

V  V  1 1 1 1  Q  III    1    1 0  1  1  w  1 

DJO,  LLC 

PMA  910066 

2013-396 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  l_  1  1/  1  /  1    Vw/  11 

1  ni irdp^  Cnha 

1—  UUI  UvO   Vw/ \JVJ\JK. 

Beckman  Coulter,  Inc. 

K1 12605 

1  V    I      1  L—  WWW 

2013-397 

01/16/2013 
02/14/2013 

0M/0MP/D0DM/ 

Doreen  Frank 

ENVISAGE  CONSULTING  LLC 

DKT  76N-052T 

2013-398 

01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/ 1  \!  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  Vw/  III    /  L/  1  L/  1  / 

Ha^an  Ahmad 

i  luooai  i  ni  ii  i  i dvj 

LEUCOVORIN  -  ANDA 

1       1        Vw/  Vw/  Vw/  V  Vw/  1    1  1  1  V|           1    V 1  VI  lw/  /  V 

02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  Vw/  III    /  1— /  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

International  Trading 
Pharmaceutical  Lab 

2013-399 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

OHAN  ARAKELIAN 
COBEG  WORLDWIDE,  LLC 

K871072,  K871073,  K871070  ETC 

2013-400 

01/16/2013 

Will  Wl  C—\J  I  o 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  W  L/  1  1  1/  Vw/  III    /  lw/  1  L/  1  / 

BRENDA  M  GARTZ 

1  )  l  l  1  1  VI  1— / 1  \   l  v  1  ■    VJ 1  V 1  l  1  L  

TETRA  GENX  ANALYTICAL  LABORATORY  ST  LAURENT 

i  i      i  i  1 1  \  Vwi  i_ i  vi /\  /  \i  hi  v i—  iii  Vw/ 1  v i      i  i  \ \  } Vw/ 1  i /  \  i  Vw/ 1  i  i  1  Vw/  i    t  /  v i  \ \  i  >i  i 

02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

QUEBEC-  EIR  4/12 

2013-401 

01/16/2013 

W  l  1    l  Wl  LU  1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1       lw/  /    V/   \w/  |  V  1  1          1    /  \w/  lw/  1         |     1/   Vw/  III       /    lw/  |  L/  |  / 

BRENDA  M  GARTZ 

1  )  l  l  1  1  VI  1— / 1  \   l  v  1  ■    Vw^  1  \  l  l  1  L  

SMITH  KLINE  BEECHAM  WORTHING  WEST  SUXXES  UK- 

Vw/ 1  v  1 1  i  i  i  i  v i_ 1 1  vi  i_  i  1 1  i  \w/ 1  it  vi  v  i  j    v  v  Vw/  i  i  i  i  i  ii  <i  Vw/    v  v  i— _ v»j  i    v_/  v*/  /  \/  \  i  v/  ^  v_/  i  \ 

02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  Vw/  III    /  1 — '  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

EIR  3/11 

2013-402 

01/16/2013 

W    l  1     l  Wl  L.U    1  U 

02/14/2013 

FDA/OGROP/ORA/PA-FO/SEA- 

1    lw/  /  V/  Vw/  V/  1  I  V_/  1    /  Vw/  1  IV  \/  I    /  \    1    \*/t  Vw/  l_  / \ 

DO/SEA-CB/ 

BRENDA  M  GARTZ 

1  )  l  l  1  1  VI  1— / 1  \   l  v  1  ■    Vw^  1  \  l  l  1  L  

ELI  LILLY  &  CO 

SHEPPARD  WOOD  DISTRIBUTORS  INC  NAMPE  ID  -  EIR 

Vw/  1   1  1  1     1     /  V 1  l  L/    V  V  Vw/  V/  L/    L/  1  ^w*  1  1  1 1  i—)  Vw/  1  Vw/  1  1  Vw/    1  1  i|  Vw/  j    1  VJV  VI V  1  1  1— —  ^    1  L/         1  III 

12/11 

2013-403 

fc-V/    1  \J      I  V-/  v/ 

01/16/2013 

W  l  I    l  Wl  L—\J\\J 

02/14/2013 

V/  L—t     1      If  L —  W    I  W 

FDA/OGROP/ORA/PA-FO/LOS- 

1    lw/  /  V/  Vw/  Vw^  1  1  V»/  1    /  Vw/  1  11  \/  I    I  \    1    Vw//  Lv/ w 

DO/LOS-CB/ 

BURGESS,  BERNIE 

EXHIBITS  FOR  2012-4657 

1  /  \  1   II  1  }  1  1  Vw/    1    Vw/  1  1   L_  V/  1  £_    *T\JJ  / 

2013-404 

01/16/2013 
02/14/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ward  Komers 

Golden  West  Biologicals,  Inc. 

K1 10641 

2013-405 

01/16/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Ward  Komers 

K1 13177 

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V_/Ul  ill  Ul  TT 

MOLIUI 1  WIIIOc 

QinnQti  iro/  Rom  loctor 
Oiy  1  IcUUl u/  ricLIUtJoLci 

OUUJtfOl 

Due  Date 

02/14/2013 

Golden  West  Biologicals,  Inc. 

2013-406 

01/16/2013 

\J  I  /    I  V//  i—  w  I  o 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \i  Vw/  1 V  1  1      1  /  \  '  is  1  11   1/  \-s  w  l__  |  1/  I — /  |    Vw/  11 

.la^nn  Waltnn 

V/  CIO  W  II    V  V  Cll  LU  1  1 

K962714  K043160  K945407 

1  V  v_/  V/ 1_  /    1  *T  1    1  XV/ ^X\J  1  \J\J  .    1  V Sw*      v/  / 

02/14/2013 

Fogless  International  AB 

2013-407 

01/16/2013 

FDA/OC/OES/DFOI/ 

Johnathan  Rickman 

FOIA  REQUEST  LOG  (01/07/2013  -  01/11/2013) 

02/14/2013 

FDANEWS 

2013-408 

t—\J  1  \J    i  \J V/ 

01/16/2013 

\J  1  /   1  V//  LU  1  O 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \-s  III    /  I — /  I  ]  /  I  / 

Audrpv  Knolarirh 

LEVAQUIN  -  AERS 

1  1      v  /  \\»X  U  1 1  v       1  \  1  l  I  Vw/ 

02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

audrey  Spolarich 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  1  \i  Vw/ 1 V  1  1      1  /  \_S  1— /  1  1  1/  \S  III    /  L/  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/DMPT/nnRH/nnFR/nFm/ 

ocu  di  i  r\.  rci  i  in 

INDIVinilAI  rfp.c; 

1 1  M  is  1  V  1  Is  \s  r\  L_  rlLV/O 

02/14/2013 

ORA/ 

SALVI  SCHOSTOK  &  PRITCHARD 

ORA/ 

PC 

FDA/OGROP/ORA/CE-FO/CHI- 

DO/0  HI -OB/ 

201 3-41 0 

01/1 6/^01 a 

rUA/UbnUr/UKA/Nt-rU/NWt- 

Tony  Taylor 

D-TAROET,  QUINOY  MA;  D-TARGET,  SWITZERLAND  -  483, 

02/14/2013 

DO/NWE-CB/ 

Aesculap,  Inc. 

REPORTS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  IS  1  / 

FDA/nMPT/nnFR/DRP/nmp/ 

n  \s r\i  v_/ivi  n  i  /  \j \s  r__  rv  v_j i  1 1  /  i_/  i  i_/ i  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

FDA/DMPT/nnRH/nnFR/nFm/ 

\  \s r\i  v_/ivi  n  i  /  \j \s  rii  1/  v_/ \_/ 1  i  i/  \s  \  v_/  i/ 

2013-41 1 

01/16/2013 

V/  1  /   1  V//  LU  1  O 

FDA/OGROP/ORA/NE-FO/NYK- 

SAMUEL  F  COLIN  MD 

\—J  1  \  \  v  1  \-J  \  1—    1        \S  Vw/  l_  1  1  >l    1  V 1  IS 

LUITPOLD  PHARMACEUTICALS  INC  -  483  2/9/11  TO  3/15/11 

l_  V/  1  1  1     V_/  1  l_/    1     1   1 1  \  1  1 1  VI/  V  V-/  1  \S  1   1  V/ 1  \  1—  V/    1 1  X  V_y          1^ V/ Vw»   L-/  v//    1    1      1  Vw/   v//   1  v//    1  1 

02/14/2013 

DO/NYK-DCB/ 

FIRST  MANHATTAN  CO 

1     II  IV_J  1     IVl/^IMI   1 1  \  1     1  rll  M    Vw/  Vw/ 

2013-412 

01/16/2013 

U  1  /  1  V//  t_V/  1  V/ 

FDA/OGROP/ORA/CE-FO/DET- 

1    1  /  /  V/  Vw/  V_^  1  1  Vw/  1    /  Vw/  1  1/  V/  V/  l__    1    Vw//  L/  1   1 

ROBERT  M  GOLDMAN 

i  i  \  '  is  \  i  ii    i  v  i  ■  ys\  v_/ 1  is  i  v  i  /  \  i  x 

HILL  ROM  INC  BATESVILLE  IN  -  483  12/12  TO  PRESENT 

1   1  1  1_  L_   1  1  Vw/  1  V 1    1  1  N  Vw/  ^  1— /V  \  1  1  V/  V  1  1  1  1  j    1  1  il        "  V/  •S     1           1  L—     1  Vw/    1     II  l__  \_j  \—  1  *l  1 

02/14/2013 

DO/DET-CB/ 

D\  Kinn  &  AQ^nriptPQ 

vL  l\ll  ILJ   LX  noOULi  1 0. o 

2013-413 

01/16/2013 

W  1  /   1  V//  L.U  1  u 

FDA/OGROP/ORA/CE-FO/NWJ- 

i   is  i  \i  Vw/  v/ 1  i  v_/ 1  /  \s  i  i  /  \/  v/ 1_  i   \s  i  n  v  v  u 

BETSY  REDDINGTON 

1— —  1  U  1      1  1 1  1 — /  IS  1  1  >l  Vwi  1  V-/  1  >J 

FEI 2246844 

1     1       1    C—  L—    1^  \J  v/  11 

02/14/2013 

DO/NWJ-CB/ 

LIGHT  AGE  INC 

2013-414 

01/16/2013 

FDA/OGROP/ORA/CE-FO/NWJ- 

1    IS  1  \!  Vw/  Vw/I  1  1  Vw/  1    /  Vw/  1  If  V/  V/  l_    1    Vw//  1  N  V  VU 

A  LUKE  SMITH 

I    \  m       1        kw7  |   \  l_      V/  1  V  1  1     1     1  1 

OHM  LABS  NJ  -  483  2008  TO  2009 

02/14/2013 

\JC—1   1  "Ty  £_  V/  1  O 

DO/NWJ-CB/ 

FARUOI  S  FARUOI  LLP 

1    i  V 1  IUVjcI    *_X    1    /  \  1  1  VJ  Vw)/ 1    1  1  1 

<£01  o-41 5 

01/16/2013 

UO/OOb/Otb/ 

JIM  MORRIS 

OUKH  BE  1  WEEN  AMEKIOAN  OHEMIb  1  KY  OUUNOIL  &  rUA 

02/15/2013 

0C/C0S/0ES/ 

CENTER  FOR  PUBLIC  INTEGRITY 

1/09  TO  PRESENT 

2013-416 

01/16/2013 

FDA/OC/OES/DFOI/ 

DONALD  F.  SEGAL 

FOOD  ADDITIVE  PETITION  FOIA  SUBMITTED  BY  GRUMA 

02/14/2013 

ALSTON  &  BIRD  LLP 

CORP;  SPINA  BIFIDA  ASSOC;  MARCH  OF  DIMES 

FOUNDATION 

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01/16/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  I  \i  V_/ 1  v  1 1     11  W  l_/  1  1  1/  W  III    /  !_/  1 1  '  1  / 

CHANDRA  TIRUVATTAR 

Vw/  1   1  /\  1  N  1— /  1  1/  \     1  1 1  1  \J  V  /  \  1    1  ni  1 

PHARMAFORCE  -  BROMFENAC  SODIUM  ANDA  02-030  SBA 

1    1  1 1  \  1  IIVI/\I    v_/ 1  \  \w/  1           1  '  1  1  Vw/ 1  V  1  1    1  1  \J  1  \  \w/  v/V/L/IUIvl  rilML/n  vJ  i—   \J\J\J  0 1  'I  \ 

02/14/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1— '  1  \l  Vw/  1  v  1  1      1  /  Vw/  L/  1  1  1/  \-s  III    /  I — /  I  L-/  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DR  REDDY'S  LABORATORIES 
INC 

2013-418 

01/17/2013 

U  1  /    1    /  /  L—\J   1  O 

02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

i   i  /  /  v/  \w/ 1  v  1 1    i  /      l/  i  ii  i/      v  '  i_  i  i/  i  / 1   \w/ 1/ 

Rarhpl  Johnson 

1  IClvvl  lul   Uvl  II  IOUI  1 

FOI  Services,  Inc. 

K884834 

2013-419 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \i  Vw/  1  v  1  1      1  /  V/  L*S  1  11   1/  V_/  V/  1— —  1  1/  1 — /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IGlV^/l  1 V/ 1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

K1 12672 

2013-420 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V/  1—  1  1/  1  /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClVvl  lul   Uvl  II  IOV/1  1 

FOI  Services,  Inc. 

K1 10030 

1  V  1    1  \J\J\J\J 

2013-421 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \J  L/  1  11   1/  Vw/  Vw/  1— —  1  1/  1  /  1    Vw/  J/ 

Rarhpl  Johnson 

1   ICLV/I  1 V/ 1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

K030302 

2013-422 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    ]  /  /  V/  Vw/  1  v  1  1      11  Vw/  L/  1  11   1/  Vw/  Vw/  l_  1  1/  1  /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClvvl  1  v>  1   Uvl  II  IOUI  1 

FOI  Services,  Inc. 

K1 12198 

1  V  I    1  L—  1  \J  L/ 

2013-423 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

K070129 

2013-424 

01/17/2013 
02/15/2013 

CVM/OCD/ 

SAYED  AHMED 

PFIZER  ANIMAL  HEALTH 

ZILPATEROL  TYPE  B  AND  TYPE  C  FEED  ASSAY  METHODS; 
TIAMULIN  TYPE  B  AND  TYPE  C  FEED  ASSAY  METHODS; 
MONENSIN  TYPE  B  AND  TYPE  C  FEED  ASSAY  METHODS 

2013-425 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    J  /  /  V/  Vw/  1  v  1  1      1  /  Vw/  L/  1  11   1/  Vw/  Vw/  l__  1  1/  L/  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClvvl  1  v>  1   Uvl  II  IOUI  1 

FOI  Services,  Inc. 

K1 03668 

2013-426 

01/17/2013 

\J  1 1  1  /  /  t—\J  1  \J 

02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  W  L/  1  11   1/  Vw/  Vw/  1—  1  1/  1 — /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClv^/l  1 V/ 1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

K101030 

1  \  1  \J  1  \J\J\J 

2013-427 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    J  /  /  V/  Vw/  1  v  1  1      1  /  Vw/  L/  1  11   1/  Vw/  Vw/  1— —  1  1/  1  /  1    Vw/  1/ 

Rarhpl  Johnson 

1  IClvvl  1  v>  1   Uvl  II  IOV/1  1 

FOI  Services,  Inc. 

K030618 

2013-428 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

K083330 

2013-429 

01/17/2013 
02/15/2013 

FDA/OC/OES/DFOI/ 

ELLIOT  FAVUS  MD 

FAVUS  INSTITUTIONAL 
RESEARCH  LLC 

2012-4834,  2012-5151,  2012-5152,  ETC 

2013-430 

t —  W  1  v/      i^Vw*  V/ 

01/17/2013 

V    1  /     lit  L —  W    1  \-> 

02/15/2013 

FDA/OC/OES/DFOI/ 

1  1— '  /V   Vw/  \w//   Vw/  l_  V-//    L-/  1       Vw/  1/ 

KYLE  SAMPSON 
HUNTON  &  WILLIAMS  LLP 

MYLAN  LABORATORIES  INC  -  FOI  REQUESTS  REGARDING 
WARNING  LTR  10/31/11 

2013-431 

01/17/2013 
02/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 
ORA/ 

JORDAN  FEIN 
UNITE  HERE 

XYIENCE  ENERGY  DRINK,  SUPPLEMENTS  -  CMPLNTS, 
RPTS,  CORR,  ETC 

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2013-432 

01/17/2013 
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FDA/OMPT/CDRH/OCER/DFOI/ 

LEX  PEARCE 
ICU  MEDICAL  INC 

BECTON  DICKINSON  &  CO  -  CLOSED  ATINEOPLASTIC  AND 
HAZARDOUS  RECONSTITUTE  AND  TRANSFER  SYS 
K123213 

2013-433 

01/17/2013 
02/15/2013 

ORA/ 
ORA/ 

DOUGLAS  N  BLUE  II 
ZETETIC  INC 

STARBURST,  CHEWING  GUM,  SKITTLES  ENTRY 
#AV3003841 36  -  RECS 

2013-434 

01/17/2013 

ORA/ 

DOUGLAS  N  BLUE  II 

IINFANT  FORMULA  ENTRY  #DP4061 71 638  -  RECS 

02/15/2013 

ORA/ 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

ZETETIC  INC 

2013-435 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

MANISH  AHUJA 
BIOTEX  INC 

K012366 

2013-436 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

MANISH  AHUJA 
BIOTEX  INC 

K090240 

2013-437 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

MANISH  AHUJA 
BIOTEX  INC 

K992304 

2013-438 

01/17/2013 

ORA/ 

DIETARY  SUPPLEMENT  WOW  -  LAB  RPT 

02/15/2013 

ORA/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

ORA/ 

ORA/ 

ORA/ 

ORA/ 

Doe  J 

2013-439 

01/17/2013 
02/15/2013 

OM/OMP/DODM/ 

BAYER,  RANGE  (RICHARD)  D 

DKT  201 1 D-0722 

2013-440 

01/17/2013 
02/15/2013 

FDA/OGROP/ORA/NE-FO/NYK- 
DO/NYK-DCB/ 

JOHN  WALSH 

JAMES  ALEXANDER  CORP 

MOD-PAC,  BUFFALO,  NY  -  EIRS,  483S,  RECALL  RECS  1/11 
TO  PRESENT 

2013-441 

01/17/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ETHYL  ALCOHOL,  TRICLOSAN,  CHLOROXYLENOL  -  SAFETY 

02/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

STEWART,  JAMES  M 

RECS 

2013-442 

01/17/2013 
02/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

BELLWYCK  PACKAGING  SOLUTIONS,  MISSISSAUGA, 
ONTARIO  -  EIR  MOST  RECENT 

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FDA/OMPT/CDER/ORP/DIDP/ 

201  3-443 

L—\J\kJ     1    1  \J 

01/17/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

i   i  '  I  \i  \w/ 1  v  1 1    ii  \j  i— / 1  i  i/  v_/  III  /  l_/  1  I—/  1  / 

BRENDA  M  GARTZ 

LJ  1  11  INLT\   Ivl         f\  \  1  1  L— 

CI  LAG  AG  SCHAFFHAUSEN  SWITZERLAND  -  EIR  201 0 

Vw /  1  L— /  V V_/   /  \V/  .    V/  Vw/  1   It  11     1     1   It  \  V/  V/  1  IN,    Vw/  V  V  1  1  ^  1  1  1 1  1  \  1  VI  1 — '         1  III   L—  V/  1  V/ 

02/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

2013-444 

01/17/2013 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  1  \i  Vw/ 1 V  1 1      I  /  VJ  1— /  1  1  1/  V_/  III    /  LJ  1  L>  1  / 

BRENDA  M  GARTZ 

LJ  1  11  l\L/r\   Ivl         1  \  \  I  1  L— 

CATALENT  UK  SWINDON  ZYDIS  LTD  SWINDON  WILTSHIRE 

Vw/  /  l  I  /  \  1  1  1  VI  1     V/  1  \  V_/  V  V  1  1  VI  L/  Vw/  1  V|   £       |   J  /  |  V/    1      I  LJ  1    Vw/  V  V  1  1  V|  LJ  Vw/  IN,    V  f  IL  1  VJ  1   1  1  1  1 1— — 

02/15/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  1 — '  1  LJ  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

-  EIR  11/11 

2013-445 

01/17/2013 
02/15/2013 

FDA/OF/CFSAN/OCD/EOS/ 

CHASTINE  12B2563,  JAMES 

SODIUM  CASEINATE  -  LIST  OF  INGREDIENTS 

2013-446 

01/17/2013 
02/15/2013 

FDA/OC/OES/DFOI/ 

ELLIOT  FAVUS  MD 

FAVUS  INSTITUTIONAL 
RESEARCH  LLC 

CTP  FOIA  REQUESTS  2010-2012 

2013-447 

01/17/2013 
02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  1  \i  Vw/  1  v  1  1      1  /  V/  l_/  1  11   1/  V_/  V/  l__  1  1/  1 — /  1    Vw/  1/ 

WEIJIA  DAI 

V  V  1  IUI  «l  1 — /  /  11 

UNIVERSITY  OF  MARYLAND 

EARLY  COLLABORATION  MEETINGS  FOR  PMA 

1  /  1 1  1 1       1     VJ  Vw /  1  1  I  \  LJ  V_/  1  I  /  \  1   1  Vw/  In    1  V 1  1  1       1  1  1  N  Vw/  V/    1    Vw/  III     1  V  l/\ 

2013-448 

01/17/2013 

\J  1  /    1    /  /  L—\J  1  \J 

02/15/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

WEIJIA  DAI 

V  V  1  IUI i  \  1 — '  I  11 

UNIVERSITY  OF  MARYLAND 

PMA  51  OK  -  DATA  ON  WITHDRAWN  AND  DENIED 

1     Ivl  1  V ,    \J  1  W  1  V        LJ/  1  1  /  I  V_/  1  VI    V  V  1  1  1   1  LJ  1  1/  I  V  V  1  VI    /  11  VI  LJ    LJ  1— —  1  VI  1  1  LJ 

APPLICATIONS 

2013-449 

01/18/2013 
02/19/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 
FDA/OC/OES/DFOI/ 

Kim  Finch 
CHOICE  SPINE  LP 

510KS  -  INDICATIONS  FOR  USE,  DEVICE  DESCRIPTION, 
SUBSTANTIAL  EQUIVALENCE  ETC 

2013-450 

l—\J  i  \J    i  vJ \J 

01/18/2013 

\J  1  /    1  \JI  L—\J\\J 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  \w/  III    /  L/  1  L/  1  / 

Tnnva  Sau^pr 

i  ui  i  y  ci  uuuooui 

SANDOZ  GMBH  KUNDL  AUSTRIA  -  483  M  0/01/201 2  - 

Vw/  /  11  VI  l_/  Vw/  L       Vw4  1  V 1  LJ  II.    IV  Kj  1  VI  LJ  1  ,    1  \  \  '  Vw/  1  1  1 1  /  V            V/  VJ    1    IV//  v/  1  /      VJ  1  L_ 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  L/  1  1  1/  V_/  III    /  ( — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Tarsa  Therapeutics  Inc. 

11/01/2012) 

2013-451 

01/18/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Brent  Ardaugh 

K004043 

02/19/2013 

\JC—l    1  \J I  L—\J    1  \J 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

Framinnham  Hpart  Studv 

i  i  cii  i  in  iui  icii  i  i  i  iucii  i  w luuy 

2013-452 

01/18/2013 

CVM/OCD/ 

Abigail  Sterling 

CHICKEN  JERKY  TREATS  FOR  DOGS  -  INTERNAL  MEMOS 

02/19/2013 

ORA/ 
ORA/ 

KPIX/CBS5 

E  \  1     1  /  V/  Vw/  UUv/ 

2013-453 

01/18/2013 
02/19/2013 

FDA/OGROP/ORA/SE-FO/ATL- 
DO/ATL-CB/ 

Linda  Bowen 
SANOFI 

CAPSUGEL,  GREENWOOD,  SC  -  EIR  JUNE  2012 

2013-454 

01/18/2013 

FDA/OMPT/CTP/OD/ 

Desmond  Jenson 

CTP  FOIA  REQUEST  LOG  (08/22/2012  -  01/17/2013) 

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02/19/2013 

Public  Health  Law  Center 

2013-455 

01/18/2013 
02/19/2013 

OM/OMP/DODIW 

Desmond  Jenson 
Public  Health  Law  Center 

FDA-2012-N-1148 

2013-456 

C—  \J  1  \J     i  •s  \J 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

David  1  in 

IS  CI  V  1  \A    L.  1  1  1 

ISOLYTE  E  (NDA  0197181 

1  \s  \s  1—  1    J  l_   1       l  l  v  IS  1  \  \J  1  \J  1    l  \J  J 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BIOLOGICS  CONSULTING 
GROUP 

2013-457 

01/18/2013 
02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  IS  1  1  1/  V_/  III    /  I — '  I  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

.Ipnnifpr  Fn^inn 

\J  \j  1  II  1 1 1  \^  1     i—  l  IOIUI  1 

Ensign,  Jennifer  D 

ANDA  APPLICATION  FOR  GENERIC  1G  MESALAMINE 

/  VI  *J  \S  1  \  I  \  l     l     LI  \S  t  \  I  I  Vw /  1  *l    1    Vw/  1  1   V_-1  1  1  N  1  1  1 1  Vw/     1  Vw4    1 V 1  1  K-f  1  \  1  J  \  1 V 1  1  1  M  1  

SUPPOSITORY  COMPARISON  TO  THE  BRAND  DRUG 
CANASA  FILED  BY  SANDOZ  IN  2007 

2013-458 

01/18/2013 

ORA/ORM/ 

David  Mangione 

LIST  OF  INSPECTIONS  (11/01/2011  -  01/15/2013) 

02/19/2013 

ORA/ORM/ 

FDAZILLA 

2013-459 

01/18/2013 

Will  KJI  L.U  1  U 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \S  I V  1  1      1  /  \w/  IS  1  1  1/  W  III    /  ( — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1 — '  I  IS  I  1 

FDA/OMPT/CDER/ORP/DIDP/ 

1  arrv  Morris 

i  ca i  i  y  iviwi  i  i o 

MORRIS,  LARRY 

THALLIUM  CHLORIDE  -  CLINICAL  TRIAL  STUDIES 

1  1   1 1  \  \  1  1  KJ  I  v  1    \s  1   1  I—  Vw/  III  IS  1            V/  1—  1  1  M  1  V/ 1  \  1—     1  1  1 1 1  \  1       \S  I  \S  IS  I  I—  \s 

INCLUDING  SIDE  EFFECTS 

2013-460 

01/18/2013 

V/  I  /    I  \JI  C—\J  I  o 

02/19/2013 

FDA/OGROP/ORA/SE-FO/FLA- 

1    IS  1  \!  \s  \—A  1  I  \S  I    I  \S  1   11  \I  *S  1—    1    \SI  I    l—l  V 

DO/FLA-CB/ 

,|nhn  Rpa^lpv 

uui  ii  i  *s v_/ c4.o i v^  y 

MedTech  Review,  LLC 

OSCOR  INC  PALM  HARBOR  FL  -  483  RESPONSES 

Vw/  \w/  V/  V_/  11,    1  1  X  Vw/  3    1    1  \  I—  1  VI    II 1  V 1  1 1  >  Vw/  1  I  ■    1    1—            v/  V-/  .11  1  \-J  1     Vw/  1  M  V/  1— —  V/ 

(07/27/2010-08/31/2010) 

2013-461 

01/18/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

David  Weissburg 

K953339,  K915774,  K051879 

02/19/2013 

FDA/OC/OES/DFOI/ 

OSS  Bo 

201 3-462 

01/18/2013 
02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \i  \s  1 V  1  1      11  \J  IS  1  1  1/  \S  III    /  IS  I  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Frir  Nnrrinntnn  PharmD  RCPR 

1  \  \\j    1  MUI  1  II  ILjLUI  1  ^    1     lldllll  IS  .    IS  \S  1  Vj 

Clark  Memorial  Hospital  Pharmacy 

I  EVOFLOXACIN  AND  AMIODARONE  -  REPORTED  CASES 

i  i  v  Vw/ 1  i  Vw//v/  Vvw/ii  n  ni  nu  i \  i  v  1 1  Vw/  is  i \  i  iv_/i  n  i         i  ii  i  v  1 1  i  i  i  is  \/nui  vj 

OF  TORSADES  AND  OTHER  SERIOUS  CARDIAC  ARYTHMIAS 

2013-463 

01/18/2013 
02/19/2013 

FDA/OC/OES/DFOI/ 

Christopher  Weaver 

THE  WALL  STREET  JOURNAL 

REATA  PHARMACEUTICALS  INC,  BARDOXOLONE, 
UNIVERSITY  OF  TEXAS  MEDICAL  CENTER  -  FOIA 
REQUESTS 

2013-464 

01/18/2013 

W  1  1    l  Wl  L-\J   I  \J 

02/19/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

LnUI  11  1  M  vJ  1  1 1  \  1  11  l 

JH  BARR  &  ASSOCIATES  LLC 

CLOSED  FOIA  REOUESTS  12/31/12-1/4/13 

Vw/ 1  Vw/  v/ 1  is  i  \s  i/  \  i  1 1  Vjiu  i  vJ  I  w    I  l—  1  \j  \  I  I  C—    i  /  *~r/  i  vj 

2013-465 

01/18/2013 

\J    \  1     1  \JI  L —  W    1  \-> 

02/19/2013 

FDA/OC/OES/DFOI/ 

LISA  TARRISON-SCHRAMP 
CanReg,  Inc. 

CLOSED  FOIA  REQUESTS  12/31/12-1/4/13 

2013-466 

01/18/2013 
02/19/2013 

FDA/OC/OES/DFOI/ 

DAVID  MCFARLAND 

FDA  WEBVIEW/FERDIC  INC 

CLOSED  FOIA  REQUESTS  12/31/12-1/4/13 

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01/18/2013 
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FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

CLOSED  FOIA  REQUESTS  12/31/12-1/4/13 

2013-468 

01/18/2013 
02/19/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

CLOSED  FOIA  REQUESTS  12/31/12-1/4/13 

2013-469 

01/18/2013 
02/19/2013 

FDA/OGROP/ORA/CE-FO/DET- 
DO/DET-CB/ 

BRENDA  M  GARTZ 
ELI  LILLY  &  CO 

CLARITA  KETELS,  ST  CLAIR  SHORES,  Ml  -  483  1 0/24/1 1 

2013-470 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  1  \l  Vw/  1 V  1  1      1  /  \J  \S  1  1  1/  \-s  III    /  ( — /  I  L-/  I  / 

BRENDA  M  GARTZ 

1  )  1  l  1  1  il  1— / 1  \   1  v  1            1  V 1  l  1  L  

HAMELN  PHARMACEUTICALS  GMBH  HAMELN  GERMANY  - 

1  li  II  v  1 1—  ^  l  n    1    II 1  \  1  1 1 VI/  V  Vw/ 1  I  I  V/r\LU  V_*i  l  v  1 1  / II)    II  /  V  i  v  1 1— —  l_  l  vi  ,         l_  I  1 1  v  1  f\  1  >J  1 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  \w/  III    /  1— /  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

483  6/4/12 

2013-471 

01/18/2013 
02/19/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

FRED  FIORE 
HYDROFERA  LLC 

HYDROFERA,  WILLIMANTIC,  CT  -  WOUND  CARE  PRODS 
K013462,  K023138 

2013-472 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

INJECTABLE  PEPTIDES  -  MARKETING  &  SALES  RECS, 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  ( — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

ORA/OCI/ 

ANDERSON,  CARL. 

COMM 

2013-473 

01/18/2013 
02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ORA/OCI/ 

ORA/OCI/ 

ANDERSON,  CARL. 

PEPTIDELELABS.COM  -  ANABOLIC  STEROIDS  OR  HUMAN 
GROWTH  HORMONE  COMM  1/1 1  TO  PRESENT 

2013-474 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    \—s 1  \l  Vw/  1 V  1  1      1  /  V  '  l—s  1  1  1/  \w/  III    /  1 — '  1  l  /  1  / 

CLAUDINE  Q  HOMOLASH 

PROTOCOL  INH-1 89-003  -  MEDWATCH  FILINGS 

1        1     l  Vw/    1    Vw/  V^/  Vw /  |_      1  1    ll  1      1         1    VJ              \J\J\J              1  V  1  1         1  '    V  V  1     \    1     Vw/  II       1        1  l_  1  1    *J  Vw^l  Vw' 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHELLER  LAW  OFCS 

2013-475 

01/18/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  \  '  Lh'  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

JOANNE  GIGORGIO 

\J  W  i  \  1  «  1  v  1— —    Vw^  1  \St  \ — '  1  l  V_^  1  v^/ 

REGLAN  (METOCLOPRAMIDE  HCL^  NDA  17-854  NDA  17- 

1  1 1  V^  1  /  \  1  vj    1  1 V  1  1— —  1  Vw/  V-/  1  Vw/  1     11  / \  1  V 1  1  lw/  l_    1   1  Vw/  1  /    1  vj  |w/  /  \     1  /     \J \J   i  ^    1  v  1 — /  /  V     1  / 

02/19/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

THERAVANCE INC 

862  -  SBA 

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2013-476 

01/18/2013 
02/19/2013 

FDA/OF/CFSAN/OCD/EOS/ 

REBECCA  LL  DANNENBERG 
FRANKLIN  &  PROKOPIK 

PHUSION  PROJECTS  -  FOUR  LOKO  WARNING  LTR 
INVESTIGATION,  CMPLNTS,  RULINGS,  ETC  11/10 

2013-477 


2013-478 


01/18/2013 
02/19/2013 


01/18/2013 
02/19/2013 


FDA/OF/CFSAN/OCD/EOS/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/ORO/DIOP/ 

CVM/OCD/ 


AIMEE  DOYLE,  ESQ. 
KOTCHEN  &  LOW  LLP 


BLIS  TECHNOLOGIES  LTD,  FRUTARON  LTD  -  FORMS  7512, 
3499,  MISBRANDING  &  UNAPPROVED  NEW  DRUG,  ETC 


TIM  SCHWAB 
Food  &  Water  Watch 


AQUABOUNTY  -  NADA  LTR 


2013-479 


01/18/2013 
02/19/2013 


FDA/OF/CFSAN/OCD/EOS/ 


ERIC  FGREENBERG 
ERIC  FGREENBERG  PC 


CHOCO  TREASURE  LLC  OR  CANDY  TREASURE  LLC,  ETC  - 
CHOCOLATE  SURPRISE  EGG  (SURPRISE  EGG  OR  CHOCO 
TREASURE)  SUBMISSIONS,  CORR,  RVWS  LAST  4  YRS 


2013-480 


2013-481 


01/22/2013 
02/20/2013 
01/22/2013 
02/20/2013 


FDA/OF/CFSAN/OCD/EOS/ 


FDA/OF/CFSAN/OCD/EOS/ 


BETHANY  KENNEDY 
EMORD  &  ASSOCIATES,  P.C. 
BETHANY  KENNEDY 
EMORD  &  ASSOCIATES,  P.C. 


WAL-MART  STORE'S  INC  -  GREAT  VALUE  ENERGY  SHOT 
CAERS 

COSTCO  WHOLESALE  CORP  -  KIRKLAND  SIGNATURE 
ENERGY  SHOT  CAERS 


2013-482 


2013-483 


2013-484 


2013-485 


01/22/2013 
02/20/2013 

01/22/2013 
02/20/2013 


01/22/2013 
02/20/2013 


01/22/2013 
02/20/2013 


FDA/OF/CFSAN/OCD/EOS/ 


FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

FDA/OC/OES/DFOI/ 


RICHARD  E  GUTTING  JR 

REDMON  PEYTON  &  BRASWELL 
LLP  

ECKHARD  MILSMANN  PHD 

DIAPHARM  GMBH  &  CO  KG 


ANTARTIC  TOOTHFISH  (DISSOSTICHUS  MAWSONI) 
MARKET  NAMES  RECS 


HAMELN  PHARMACEUTICALS  GMBH  -  483  6/4-14/12 


Doe  J 


NATURALLY  TE  -  BLACK  BOX  WARNING,  REGULATORY 
HISTORY,  RECALL  RECS 


LORI  PFOHL 
TELEFLEX  MEDICAL 


MELKER  EMERGENCY  CRICOTHYROTOMY  CATHETER  KIT 
K013916 


2013-486 


01/22/2013 


ORA/ 


PHARMEDIUM  SERVICES  LLC  -  WARNING  LTRS,  EIRS, 
483S,  ETC  2010  TO  PRESENT;  AMERIDOSE  LLC  -  EIR 


Page  236  of  895 


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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

02/20/2013 

ORA/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \l  Vw/  1  v  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  I  /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

KYRIAKIDIS,  JOANNA 

7/21/08,  ETC 

2013-487 

01/22/2013 
02/20/2013 

ORA/ 
ORA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

MARLA  F  MUNOZ 
SEADCO  USA  CORP 

FROZEN  PASTEURIZED  EXTRA  JUMBO  SEADCO  U-130, 
EXTRA  JUMBO  MARISSIMO  U-250  ENTRY  #E49-0022287-7 
-  LAB  RESULTS 

2013-488 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    I  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \s  III    /  1 — '  1  L/  1  / 

AMBIEN  SEROQUEL  -  AERS 

/  vi  v  1 1  '  1 1__  i  n  j  \s  \—  i  i  Vw/  \tX  v/  I  I—      I  v  i_  i  i 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      II  \m/  L- /  1  1  1/  \-s  III    /  I—/  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SCOTT  #JY1 51 2/L-27,  SEAN 

2013-489 

01/22/2013 
02/20/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

1    IS  1  \l  Vw/  \J  1  I  Vw/  1    /  Vw/  1  1/  V/  1  VI  l_    1    Vw//  1  M  VV  1  

DO/NWE-CB/ 

ANTOINETTE  PERRY 

I  \  1  VI    1   V  /  1  1  l|  1        1     1    1         1      1  1    l  1    l  1 

ADAMMAS  CONSULTING  LLC 

PAREXEL/PERCEPTIVE  BILERICA  MA  -  EIRS  483S  CO 

1     /  \  1  1 1  /  \  1  l—!  1     l__  1  I  V  '  l_  1      1   1  V  1  ,    L/  1  1  1  III  \S  l  \  ■    1  Vl/i        1  III       ,    "UUU  ,    V/  Vw/ 

RESP  2/14-23/12 

2013-490 

01/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \l  \S  1 V  1  1      II  \S  IS  1  11   II  W  \w /  l_  1  1/  \S  1    Vw/  1/ 

Innptta  Walkpr 

II  II  \\j  L  LCI    V  V  GU  1 

K090385  K060721  K093679  ETC 

1  \                       J1    1  V  V/  V-/  V/  /  £_  I.I  \\J  \J\J\J  1  \J    l_  1  V/ 

02/20/2013 

FDA/OC/OES/DFOI/ 

ESTECH 

2013-491 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V  '  IS  1  11   II  Vw/  V  '  l_  1  1/  IS  1    Vw/  1/ 

Oathprinp  Sharhaf 

V_/  CI  L 1  1  \j  1  II  \\j    \S\  luwl  1  CI  1 

Orlucent 

VIZILITE  BLUE  ORAL  EXAMINATION  -  APPROVAL  RECS 

V  1  £  1  1  1  1  1        1  >  \  V_/  1        Vw/  1  1/  \  1       1_  /  V  /  V 1 V 1  1  1  HI  \  1  1  V_/  1  N        /  V 1     1     1  I  Vw/  V  1  V  L_   1  1  1  V/  v_/ 

2013-492 

01/22/2013 
02/20/2013 

FDA/OGROP/ORA/CE-FO/DET- 

1    L/  /  V/  Vw/  V/  1   I  V_/  1    /  Vw/  1  1/  V/  V/  1— —    1    \S  1  IS  1   1 

DO/DET-CB/ 

Juriv  5-ladlpr 

IU  Health  Goshen  Hospital 

IU  HEALTH  GOSHEN  HOSPITAL  -  483  EIR  M  1/01/2012  - 

1  \J    1   1  1  /  V  1_  1  1   1    V_^  V_/  v/  1   1  1— —  1  il    II  Vw /  U  1     1  1  f  \  \            ^\J\J  ,    l_  III    II    1  /  \J  1  /  £_  V/  1  £— 

11/06/2012) 

2013-493 

t_w  1  v/    i  \J  v/ 

01/22/2013 
02/20/2013 

FDA/OC/OES/DFOI/ 

1    L/ 1  \l  Vw/  Vw//  Vw/  1 —  VJ/  1— /  1    Vw/  1/ 

.lohnathan  Rirkman 

\J\J\  II  1  C4  L  1  Idl  1    1  ll\_/[VI  1  1  C4  1  1 

FDA  NEWS 

FOIA  REQUEST  LOG  f01/14/2013  -  01/18/20131 

1    Vw/  1 1  \    1  1 1 — \jC    *  1 —  *S>  1  1 —  Vw/  V^    1  U  1  /    1  ~T/  L—\J  1  U        V/  1  /    1  V//  I—  W  1  \J  } 

2013-494 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Madalyn  Duncan 
Impact  medical,  LLC 

K1 1 3399,  K1 1 0086,  K071 035 

2013-495 

01/22/2013 
02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    ]  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  Vw/  III    /  L/  1  l  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

.Ian  Pptranpk 
Petranek,  Jan 

SINEQUAN  -  POST  MARKETING  SAFETY  ISSUE  RECS 

Vw/  1  1  M  l__  V_x  v/  1  \  1  Y        1     Vw/  O  1     1  Vl/i  1  1 1  \  1       1  IIM  Vwi    V/  /  V 1     1       III  V/  \S  \S  \        1  1 1__  V/  V/ 

(01/01/2000-01/01/2013) 

2013-496 

01/22/2013 

'   1  /  i—l—l  L—\J\\J 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \s  III    /  1 — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

.Ian  Pptranpk 

Uui  i  i    v/  L I  a  i  idv 

Petranek,  Jan 

SEROOUEL  -  POST  MARKETING  SAFETY  ISSUE  RECS 

\s  i  i  i  Vw/  v»x  v_/  i__  i          i    Vw/  Vw/  i    i  v  i  /  v  i  1 1  \  i__  i  1 1  v       v/  /  \  i    i__  i    i    i  ^/     v/  i— _  i  1 1_  v/  Vw/ 

(01/01/2000-01/01/2013) 

Page  237  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

201  "3-497 

01/22/2013 
02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      1  /  W  l_/  1  1  1/  W  III    /  !_/  1  1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

mirhplp  hnnn 
michele  hong 

ORESTOR  7f)COR  LIPITOR  ETC  -  SUPPLEMENTAL  NEW 

W  1  1 1  \J  1  \S  1  I  .    £—\s*S\s  11,    1  II     II  \s  II,    1       1  Vw/  V— /       1     1     1  1  1 VI 1  1  M  1  1  \  1       INI  V  V 

DRUG  APPLICATION  PROCESS  RECS 

2013-498 

01/22/2013 
04/08/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

IS  v — /    l_/  /  V  l_  \JiSil 

Christopher  Rush 

FDA  Quality  and  Regulatory 
Consultants 

CHRISTOPHER  RUSH  -  BIMO  INSPECTIONS  (01/01/2002  - 
01/01/2008} 

2013-499 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Mick  Fenton 

Immunodiagnostic  Systems  Ltd 

K070788 

2013-500 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  / 1  \!  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \s  III    /  1 — '  1  IS  1  / 

Ch;arlip  7hou 

QSYMIA  CAPSULE  -  CMC  AND  BIOPHARMACEUTICAL 

VxW  i  i  v  1 1 1  \  \s i  \  \    ys  \s>  \  i_       \s  i  v i  Vw/  i  \ i  h  is  is  i  \s  i    i  1 1  \  i  \ i  v  i  /  \\s  \  *s  i  i  \s I  \ \  

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  \w/  IS  1  1  1/  V_/  III    /  ( — '  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Living  Stream  Food  and  Drug 
Consulting 

REVIEW 

2013-501 

01/22/2013 
02/20/2013 

FDA/OGROP/ORA/SW-FO/KAN- 
DO/KAN-CB/ 

Annpla  Turnpr 

I  \  1  lUUlU     1  Ul  1  IV^l 

Turner,  Angela 

LLOYD  INC  SHENANDOAH  IA  -  EIR  fMAY  2012} 

L_  1_  V  /  1   \S  ^    MM  Vw/  j         1   1  1  1  il  1  V 1  M  L-/  Vw/  V  \  1   1  3    1  /  V        l_  III    II  VI/  1  1     L—  \J  1  C—  1 

2013-502 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Walt  Brittle 

FDA  Compliance  Help  Desk  Inc 

LINA  MEDICAL  APS,  GLOSTRUP,  DENMARK  -  483,  EIR, 
CORR  (01/01/2006  to  01/01/2013) 

2013-503 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

Rrandip  R  Durrptt 

IS  1  Gil  lul  v    1  I    IS  Ul  1  O  L  L 

NUVIGIAL  -  AERS 

1  M  \J  V  1  \v4  1 1  \  l_        1  \  l_  1  I 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Durrett,  Brandie  R 

2013-504 

01/22/2013 
02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      11  \  '  IS  1  1  1/  > — /  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \S  IS  1  1  1/  W  III    /  I — '  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Bill  Webster 

IS  III    V  V  UUO  IU  1 

UNIVERSITY  OF  SYDNEY 

GUIDELINES  FOR  REPRODUCTION  STUDIES  FOR  SAFETY 

\**A  KJ  1  IS  \  ^  1  1  M  1  \—J    1    \S  1  1    1  1 1  1     1  I V  /  Lri/  Vw^  V^/  1   1  Vw/ 1  M    VJ  1  V_/  Lri/  1  1  v_/    1    V-/  1  I            \  1     1       1  1 

EVALUATION  OF  DRUGS  FOR  HUMAN  USE  (1966) 

2013-505 

01/22/2013 

ORA/ 

Richard  O.  Wood 

144-4574669-8  -  LAB  RESULTS 

02/20/2013 

ORA/ 

the  Wood  Burditt  group 

2013-506 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \w/  1  v  1  1      1  /  \w/  L-/  1  1  1/  V_/  III    /  I — '  1  IS  1  / 

Rpniamin  Dro^man 

IS 1  II  CI  1  1  1 1 1  1    iS  I  UOI  1  1  CI  1  1 

LUCENTIS  -  APPROVAL  PACKAGE 

1  \S  \S  1  1  i  1  1  \S        <  •  1     1     1  I  Vw/  v  /  V  I—   1    /  V  V-/  1  V 1  \  l_ 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

REGENERON 
PHARMACEUTICALS  INC 

2013-507 

01/22/2013 
02/20/2013 

CVM/OCD/ 
ORA/ 

Steven  A  Roach 

FOOD  ANIMAL  CONCERNS 
TRUST 

Date  Range:  08/01/2001  -  01/14/2013;  Records  related  to  the 
feed  investigation  of  a  domestic  United  States  cow  that  was 
reported  as  infected  with  Bovine  Spongiform  Encephalopathy  on 

Page  238  of  895 


Tuesday  October  22  2013  1 :54  PM 


Disclosure  FOI  Request  Log  Date  range  from  10/01/2012  to  09/30/2013  Report 

Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

ORA/ 

FDA/OC/OES/DFOI/ 

April  24,  2012.  Specifically  records  related  to  the  firm  described 
as  "One  facility  processed  and  manufactured  with  poultry  waste 
in  the  report  "Final  Feed  Investigation  Summary  -  California  BSE 
Case  -  July  201 2"  which  is  available  on  the  FDA  website.  The 
focus  of  our  request  is  whether  or  not  the  infected  cow  was  likely 
exposed  to  ruminant  meat  and  bone  meal  through  the  feeding  of 
the  form  of  poultry  waste  known  as  poultry  litter.  In  addition  we 
would  like  to  better  understand  FDAs  risk  communication  about 
the  feed  particularly  how  FDA  chose  to  communicate  to  the 
public  whether  or  not  the  cow  was  actually  exposed  to  ruminant 

■                     1     1                                               lil                           1                           1  J.              1  "  L  L                   A  It'll 

meat  and  bone  meal  through  poultry  litter.  A  more  detailed 
request  and  a  request  for  a  fee  waiver  are  included  in  the 
attached  file.  The  wide  date  range  of  records  is  aimed  at 
capturing  feed  investigations  that  occurred  during  the  life  of  the 
cow,  but  before  it  was  identified  as  being  infected.  ; 

2013-508 

01/22/2013 

\J  1  /  L—  L—l  L—\J\\J 

02/20/2013 

FDA/OMPT/CTP/OD/ 

1  1 — '  1  \!  Vw/ 1  v  1 1      1  /  \  '  1  1    /  Vw/  1 — /  / 

Rqphpl  .Inhn^on 

1  IClVh/l  1  V^s  1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

TOBACCO  ESTABLISHMENT  REGISTRATIONS  AND 

1  vV  1— '  /  V  Vw/  Vw/  Vw/    1  vJ  1  /  iLJIw  1  Vw/  1   1 1 V  1  1— —  1  VI  1     11 1  Vw4  1  Vw*  1  1  1 1  \  1  1  Vw/  1  V|  Vw/  1  \  1  VI  lw/ 

TOBACCO  PRODUCT  LISTINGS 

2013-509 

01/22/2013 
02/20/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Brian  Kpnnpdv 

i  } \  i ci i  i  i  \ \w* i  ii  i Vw* vj  y 

AYER  CAPITAL 

MONSTER  BEVERAGE  -  EMAILS  SLIDES  OTHER  RECS  RE 

1 V  1  Vw/  1  VI  \_J  1  l_  1  l  l— J  \       V  1  1  \i  V  Vw4  1             l_  1  V  1  /  V  1  L_Vw/  ,    U  1—  1  lw/  1— —  K->  ,    Vw/  1  1   1  l_  1  1    1  I  L_  \w*  Vw/    1  1 1_ 

11/30/12  MEETING  WITH  FDA 

2013-510 

01/22/2013 
02/20/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Barbara  Kowinsky 
KOWINSKY,  BARBARA 

THIBIANT  INTERNATIONAL  -  EIR,  WARNING  LETTER,  483 
(01/01/2012-01/11/2013) 

2013-51 1 

01/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1     lw/  /  V/  Vw/  1  V  1  1       11  \J  \—S  1       1    1/  Vw/  III     /  1 — '  1  1— /  1  / 

Annplia  Slavtnn 

i  \  i  iy  vj  i  i  ex.  o  i  ci.  y  ivji  i 

DYMISTA  -  SBA  202236  000 

lw/    1    IV  1  1  Vw/   1  I  \         Vw/  1—*  1  \    i—  w  L  L_  v_J  W  WWW 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2013-512 

01/22/2013 

FDA/OGROP/ORA/CE-FO/BLT- 

Angelia  Slayton 

JOSE  HERNANDEZ  -  483  (01/01/10  TO  PRESENT) 

02/20/2013 

DO/BLT-CB/ 

1— /  Vw//  I—'  1—  1     Vw/  l__J/ 

INC  RESEARCH  CONSULTING  & 
SUBMISSIONS 

2013-513 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1       lw/  /    V/   \w/  1  V  1  1          1    /   W  lw/  |     11      1/   Vw/  Vw/  1— —  1     1/    lw/  1       Vw/  i/ 

Rarhpl  Johnson 

1  IdVt/l  1  V^s  1   UUI  II  IOUI  1 

FOI  Services,  Inc. 

K1 10699 

1  \  1    1  \J\J\J  sJ 

2013-514 

01/22/2013 
02/20/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

K121194 

2013-515 

01/22/2013 
02/20/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

P*/"*/!/ A  M  /"*D/ 

UU/KAN-Od/ 

Bayer  HealthCare  LLC  Animal 

1    InnUU     /  1    )  ■  >4-U.     1     n           1  m  i\ 

Health  (Kuth  Lamley) 

Bayer  HealthCare  LLC  Animal 
Health 

BOEHRINGER  INGELHEIM,  ELWOOD,  KS  -  483,  EIR  (4/2/2010, 
1 1/23/2009,  1 1/6/2008,  1 1  O) 

2013-516 

01/22/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Law  Offices  of  Ronald  A.  Marron 

NATURE'S  WAY/SCHWABE  NORTH  AMERICA  -  CORR  WITH 

02/20/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

Law  Offices  of  Ronald  A.  Marron 

FDA 

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V_/UI  III Ul  tt 

Due  Date 

MO  LIU  1 1  WIMOtJ 

oILJMalUit!/  nc^Uuolcl 

OUUJtfOl 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  1  \i  V_/ 1 V  1 1      11  \J  1— /  1  1  1/  W  III    /  !_/  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

01/22/2013 

\J  1  /  t—(—i  L-\J  1  vJ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1 1      11  \J  LJ  1  1  1/  W  III    /  !_/  1 1  '  1  / 

Gen  Li 

CLINICAL  INVESTIGATOR  DATA  -  FORM  1572  HUMAN 

Vw/ 1  1 1  m i  v/ 1  v i      ii  m  v  i  \j  i  i \jr\  i  Vw/ 1  i  !_/ /  \  i  n       i  v_/ 1  1 1 vi    u  /  l  i  i  w i v i #  % i  n 

02/20/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  L/  1  1  1/  V_/  III    /  1— /  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

personal  use 

DRUGS 

2013-518 

01/23/2013 
02/21/2013 

OC/OM/OMP/DDM/ 

MARILYNN  WHITNEY 
COVINGTON  BURLING  LLP 

DKT  FDA-2006-P-0007,  FDA-2007-D-0433,  ETC. 

2013-519 

01/23/2013 
02/21/2013 

OC/OM/OMP/DDM/ 

WEblLEY  ALBUQUERQUE 

NATIONAL  CORPORATE 
RESEARCH 

OTC  VOL.  070280,  070270,  070238,  ETC. 

2013-520 

01/23/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

Adam  S.  Morgenthau,  MD 

KVIEM-SILTZBACH  SKIN  TEST  -  IND 

02/21/2013 

ALFB/ 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  \w/  III    /  1 — '  1  L-/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MOUNT  SINAI  MEDICAL  CENTER 

2013-521 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  1 — '  1  l_/  1  / 

Garv  Wolff 

VYVANSE  -  FAERS  6601306  6615751  6650425  ETC 

V    1    V  /  VI  M  V/  1             1    1  V  l_  1  1 V/   UUv  1  vVU  i    v/  V  1  \J  1  \J  1  ■    V/  V/  v/  V/      L_  Vw*    1       1  \J 

02/21/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

SHIRE  PHARMACEUTICALS  INC 

2013-522 

01/23/2013 
02/21/2013 

CVM/OCD/ 

Ruth  Lamley 

Bayer  HealthCare  LLC  Animal 
Health 

GRINDEX,  LATVIA  -  483,  EIR  (04/27/2007) 

2013-523 

01/23/2013 
02/21/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Robert  Haggerty,  Sr.  VP  Corporate 
QA/QC 

Lyophilization  Services  of  New 
England 

LYOPHILIZATION  SERVICES  OF  NEW  ENGLAND,  BEDFORD, 
NH  -  EIR  UNREDACTED  (06/02/201 1  -  06/09/201 1) 

2013-524 

01/23/2013 
02/21/2013 

V/  £_/  L —    1  /  L —  V/    1  U 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

Lauren  Farruggia 

Hvman  Phplo^  and  McNamara 

1    1  V  1  1  1  Ul  1  g     1      1  lw  1  k/O    LAI  1 V/    1  V  1  \-f  1  N  LA  1  1  1  LA  1  LA 

TG  UNITED,  INC,  BROOKSVILLE,  FL  -  483,  EIR  WARNING 
LETTERS,  ETC 

2013-525 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Joan  Stitt(UG2CD-16) 

ISR  4457069-8,  3197882-0,  5874061-7  ETC 

02/21/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

MERCK  &  CO.,  INC. 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-526 

01/23/2013 

AO  /O  -1  /OA  -i  o 

U^/^1/<;U1  o 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

Carole  Kempfer 

□  AniAMT  DCCCADPU 

KAUIAN  1  KbbbAKOn 

DYNAVAX  -  INSPECTION  REPORT  (10/18/2012  -  11/16/2012) 

2013-527 

01/23/2013 
02/21/2013 

FDA/OC/OES/DFOI/ 

KEN  REID 

I  \  1— —  1*1    11 1  1  IS 

WASHINGTON  INFORMATION 
SOURCE 

FOI  DAILY  LOG  12/31/12-1/4/13 

2013-528 

01/23/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

FOI  DAILY  LOG  12/3/12-1/4/13 

02/21/2013 

FDA/OC/OES/DFOI/ 

WOLTERS  KLUWER  LAW  & 
BUSINESS 

2013-529 

01/23/2013 

FDA/OC/OES/DFOI/ 

DEBI  COHEN 

FOI  DAILY  LOG  12/3/12-1/4/13 

02/21/2013 

FDA/OC/OES/DFOI/ 
FDA/OC/OES/DFOI/ 

CanReg,  Inc. 

2013-530 

01/23/2013 

FDA/OC/OES/DFOI/ 

WILLIAM  A  OLSON 

FOI  DAILY  LOG  12/31/12-1/4/13 

02/21/2013 

FDA/OC/OES/DFOI/ 

Center  for  Regulatory  Services,  Inc. 

2013-531 

01/23/2013 
02/21/2013 

FDA/OC/OES/DFOI/ 

LAUREN  S  BARR 

JH  BARR  &  ASSOCIATES  LLC 

FOI  DAILY  LOG  12/31/12-1/07/13 

2013-532 

01/23/2013 
02/21/2013 

FDA/OC/OES/DFOI/ 

FOI  Services,  Inc. 

FOI  DAILY  LOG  12/31/12-1/4/13 

2013-533 

01/23/2013 
02/21/2013 

FDA/OC/OES/DFOI/ 

BARBARA  JONES 
DOMINION  GROUP  INC 

FOI  DAILY  LOG  12/31/12-1/4/13 

2013-534 

01/23/2013 

AO/01  /OAi  O 

ORA/ 

UriA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DONALD  N  BLUE 

Z.L  1  L  1  IO 

CHOCOLATES  SMLU3185964A  -  PHOTOGRAPHS,  OASIS 
SCREEN  SHOTS,  CBP  FORM  3461 

2013-535 

01/23/2013 

AO/01  /OA1  Q 

ORA/ 
UriA/ 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

DONALD  N  BLUE 

Z.C  1 1 1  ILi 

CHOCOLATES  SMLU3152799A  -  PHOTOGRAPHS,  OASIS 
SCREEN  SHOTS,  CBP  FORM  3461 

2013-536 

01/23/2013 
02/21/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

ORA/ 

ORA/ 

DONALD  N  BLUE 
ZETETIC 

CHOCOLATES  SMLU31 79805A  -  PHOTOGRAPHS,  OASIS 
SCREEN  SHOTS,  CBP  FORM  3461 

2013-537 

01/23/2013 
02/21/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

PAUL  W  TRIPP 
LINCARE  INC 

THH  ACQUISTION  LLC  (TOTAL  HOME  HEALTH)  -  EIRS.  483S, 
WARNING  LTRS  1/04  TO  PRESENT 

2013-538 

01/23/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Carol  Wasteneys 

ROHTO-MENTHOLATUM,  THUAN  AN  TOWN,  VIETNAM  -  EIR 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

02/21/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  \w/  1 V  1  1      1  /  \m/  L- /  1  1  1/  \-s  III    /  1 — /  I  J  /  I  / 

FDA/OMPT/CDER/ORP/DIDP/ 

The  Mentholatum  Company 

(05/15/12  TO  01/22/2013) 

2013-539 

01/23/2013 
02/21/2013 

FDA/OGROP/ORA/CE-FO/MIN- 
DO/MIN-CB/ 

IS  \_//  1 V  1  1  1  N    V_/  1  '/ 

Doe  J 

INDIVIDUAL  RECS 

2013-540 

01/23/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

JOHN  CREWDSON 

MERCK  -  ZOSTAVAX  FINAL  PROTOCOL,  RPTS  1 1/06.5/07, 

02/21/2013 

ALFB/ 

PROJECT  ON  GOVERNMENT 
OVERSIGHT 

11/10  5/11 

1    1  /  1  U,   \JI  1  1 

2013-541 

01/24/2013 

FDA/OMPT/CBER/OCOD/DDOIW 

Gary  Koenig 

BAXTER  TISSEAL- 51  OK 

02/22/2013 

ALFB/ 

Gary  Koenig 

2013-542 

01/24/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Shannon  James 

ANCEF  -  APPROVAL  HISTORY;  LABELING  REVISION 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  V^/  III    /  I — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  \S  1 V  1  1      11  \J  IS  1  1  1/  > — /  III    /  1 — '  1  i  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

Northprn  Navaio  Mpdiral  Opntpr 

HISTORY 

2013-543 

01/24/2013 

OM/OMP/DODM/ 

\S  1  v  1/  V^*  1 V  1  1    /  \S  \S  IS  1 V  1/ 

Mirhapl  filatpr 

DOXORUBICIN  HYDROCHLORIDE  -  COMMENTS  ON  DRAFT 

1 — /  \—s  /  \  \-s  I  1  \S  IS  1  w  1  1  il    III   IS  I  V  \-s  \-J  1   1  1  \-s  I  I  I  IS  1             Vw/  Vw/  1  V 1 1 V  1  1— —  1  *J  1  O   Vw/  1  x    lw/  1  t  / \  1  1 

02/22/2013 

Merrimack  Pharmaceuitcals,  Inc. 

GUIDANCE 

2013-544 

01/24/2013 
02/22/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

Rachel  Johnson 
FOI  Services,  Inc. 

LSNE,  BEDFORD,  NH  -  EIR  (6/2/11) 

2013-545 

01/24/2013 
02/22/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/B  LT- 
DO/BLT-CB/ 

\S\SI  IS  1_  1  \*/\S}/ 

Sandy  Stagge 

CTI  Clinical  Trial  &  Consulting 
Services 

JOHNS  HOPKINS  UNIVERSITY  SCHOOL  OF  MEDICINE  IRB  - 
483  RESPONSE  (01/07/1 1} 

i  KJ  \-f  ,    I   1 1_  \S  1     >w/  1  >l  U  1        \\J  I  t  \J  i  /    1    1  J 

2013-546 

01/24/2013 
02/22/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Murray  Carpenter 
Murray  Carpenter 

STARBUCKS  COFFEE,  TEA  -  CAERS  (01/01/2004  - 
12/31/2012) 

201 3-547 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1— /  / V/  Vw/ 1 V  1 1      11  \J  IS  1  1  1/  V  /  III    /  l_/  1  L-/  1  / 

INDIVIDUAL  RECS 

1 1  M  IS  1  V  1  IS  UAL    1  1 1  \_/ \J 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Doe  J 

201 3-548 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \i  \S  1 V  1  1      11  W  l_/  1  1  1/  W  III    /  [_/  1  IS  1  / 

Raphpl  .InhnQon 

1  1u<jI  ICI   UUI  II  IOUI  1 

NDA  202292 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

2013-549 

01/24/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Michael  Atkins 

B&B  INTERNATIONAL,  LINDEN,  NJ  -  PACKING  PERMITS  AND 

02/22/2013 

ORA/ 

Atkins  Intellectual  Property,  PLLC 

RECS 

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Total  Records:  9990 


Control  # 

Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

ORA/ 

FDA/OGROP/ORA/CE-FO/NWJ- 
DO/NWJ-CB/ 

2013-550 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Dustin  Block 

ANDA  079040  -  EFFECTIVE  APPROVAL  LETTER 

02/22/2013 

FDA/OM  PT/CD  E  R/OR  P/D I  DP/ 

1    1  '  / V/  Vw/ 1 V  1 1      1  /  V_/  1— /  1  1  1/  V_/  III    /  1— /  1  L>  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  '  / V/  Vw/ 1 V  1  1      1  /  W  l_J  1  1  1/  W  III    /  !_/  1  1  '  1  / 

FDA/OC/OES/DFOI/ 

IPD  Analvtirq  1  1  O 

1 1    I  '  / v  1  idly  li  VjO  .  I  i_  vj 

201 3-551 

01/24/2013 
02/22/2013 

FDA/OC/OES/DFOI/ 

MU.JIB  LJ  OIDWAI 

1  V  1  LJ  w  1  1  '    W.    V_/  1  l_/  V  V  /  \  1 

GRIFOLS  BIOLOGICALS  INC 

OCTAPHARMA  AB  STOCKHOLM  SWEDEN  -  EIR  483  1/11 

Vw/  \w/  i  ni    i  1 1  \  i  1 1  v  \r\  I  \  i  > .  vj  i  Vw/  \w/ 1  \i  i\_/ 1  i  v  i ,  w  v  v  i  lj 1  in      i  1 1  i ,  tuu    i  /  i  i 

2013-552 

01/24/2013 

\J  1  /  £—  TV  L.U  1  U 

FDA/OC/OES/DFOI/ 

1  1— '  /  V/  Vw/  Vw//  Vw/  1 —  VJ/  1—/  1    VwX  1/ 

MUJIB  U  OUIWAI 

1  v  1  VJ  VJ  1  LJ    V/  .    V_j<  VJ  1  V  V  /  \  1 

CSL  BEHRING  VICTORIA  AUSTRALIA  -  EIR  483  1/10  TO 

Vw/  Vw/ 1_   LJ  l__  1   II  1  1  1  N  Vwi  1     VI  V/  1  Vw /  1  1  1  /  V  ,   t  \  V/  VJ  1  1   1  /  V  I—  1 1  V        1  II  I .      i      \J     1/    1  V     1  Vw/ 

02/22/2013 

GRIFOLS  BIOLOGICALS  INC 

12/31/12 

2013-553 

01/24/2013 
02/22/2013 

BRENDA  M.  GARTZ 
ELI  LILLY  &  CO 

RECORDATI,  CAMPOVERDE,  ITALY  -  EIR  7/10 

201 3-554 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  V  1  1          1    /   V  '  lw/  1         |     1/   Vw/  III       /    |_/  |  L/  |  / 

BRENDA  M  GARTZ 

lj i  ii  i  ML/r\  ivi.  uni  i  i  i— 

.IANSSEN  BIOLOGICS  LEIDEN  NETHERLANDS  -  EIR  MOST 

VJ/\INvJvJl  IN    1  I  \  Vw/ 1  Vw/       1  V/  vJ  .    1  1  1  LJ  1  IN,   INI       1  1  II  1  11  rVI  <IUiJ       1  II  1  IVIV_/>_/  1 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

RECENT 

2013-555 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1       1  /  /    V/   Vw/  1  V  1  1          1    /  Vw/  1—/  1         1     1/    >  /  III       /    1  '   1  LJ  |  / 

BRENDA  M  GARTZ 

LJ  1  1 1__  1  N  1  J  1  \   1 V  1  ■    Vwi  1  V 1  1  1  L  

DAITO  PHARMACEUTICAL  CO  LTD  TOYAMA  CITY  JAPAN  - 

1  >  1  W  1  VhJ    1     1   11  VI  1 1 V  1  /  \  > — /  l_  Vw/  1   1  Vw/  /  \  1       \J  Vw /    l_  1  LJ  3     1  Vw/  1  V  \  1  VI/  \   VJ  II     1  j   U  /  V 1    I  \  1  N 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  VJ  LJ  1  1  1/  V_/  III    /  L/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ELI  LILLY  &  CO 

EIR  9/11 

2013-556 

01/24/2013 
02/22/2013 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

PATRICIA  L.  REGENYE 
Celgene  Corporation 

ANNELIESE  GONZALEZ,  CORPUS  CHRISTI,  TX  -  483  1 1/08 
TO  PRESENT 

2013-557 

01/24/2013 
02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  1—/  1  1  1/  W  III    /  I — '  1  1  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  lw/  1  1  1/  > — /  III    /  1 — '  1  !_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

PATRICIA  L  REGENYE 

1    1  \  1  1  1  1  Vw/  1 1  V   1_ .    II  1  VJ  1  1  N   1  1  

Celgene  Corporation 

MUHAMMAD  SALIM  ALLAN  BLAIR  CANCER  CTR  REGINA 

1 V  1  VwS  1   1 1  V 1 V  1  1  V  1 1  \  1— /    Vw/ 1  V  L_  1  1  V 1  -   V  \  1_  L_/  V 1  N    LJ  l—l  \  III    VJ/\I  N  VJ  1  1  I   VJ  III,    II  l_  V—i  1  1  N  /  \  . 

CANADA  -  483  12/03  TO  PRESENT 

2013-558 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  VJ  LJ  1  11   1/  V_/  V/  1— —  1  1/  1 — /  1    Vw/  1/ 

CAROLYN  L  WAGNER 

VJ 1  \  1  l  V-/  LIN    l_  ■    V  V  1  V  V_/  1  *J  l__  1  I 

CARESTREAM  HEALTH  INC 

SHIMADZU  CORP  -  DAR7000  RADSPEED  SAFIRE  K050925 

\J  1   III  V  1 1  \  1—/  £.  V/    V_/  V_/  1  II  1 — /  /  VI  I  /  UV/v    1  1 1  \  LJ  Vw/  1     1  1  LJ    VJ/»  1     1  1  1 1        1  \UwU  v_/  L_  \J 

2013-559 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

CAROLYN  L.  WAGNER 
CARESTREAM  HEALTH  INC 

FUJUFILM  SYSTEMS  USA  INC  -  FDR  ACSELERATE 
STATIONARY  XRAY  SYS  K093427 

2013-560 

01/24/2013 

CVM/OCD/ 

KRISTI  0.  SMEDLEY,  Ph.D. 

FAP  OA4200 

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Pnntrnl  if 

rit?OU  Udlc  / 

Due  Date 

moliuii  vjiiiofc? 

oiyildlUlc/  ritJLjUcblci 

Ci  1  |[~li£!l/"»t 

ouujfcfui 

02/22/2013 

Center  for  Regulatory  Services,  Inc. 

2013-561 

01/24/2013 

\J  1  /  <—  TV  L.U  1  U 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \l  Vw/  1  v  1  1      1  /  V/  lw/  1  1  1/  \-s  III    /  1 — f  I  L/  I  / 

XTANDI  A  -  AER 

/\  1  I  V 1  X  lw/  1   1  \        1  V  l_  1  I 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

SMITH,  KIMBERLY. 

2013-562 

01/24/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    IS  1  \!  \s  1 V  1  1      1  /  \  '  lw/  1  11   1/  \-s  \_s  1—  1  1/  1 — /  1    Vw/  1/ 

RADIONICS  MEDICAL  INC  -  SPECTRUM  ANALYZER  8000 

1  \i  \  lw/  1  V-/  1  >J  1  V/  U    1  V  1  1  lw/  1  \  '  f  \  \       1  1  >l  V-/        U  1     1  Vw/  1  1  1  Vw'  1  V 1   1  \  1  N 1  \  1—  1  £  l_  1  I   V/  \J  \J  \J 

02/22/2013 

SUSSMAN,  MARVIN  L 

K810851 

2013-563 

01/24/2013 

FDA/OMPT/CBER/OCOD/DDOM/ 

BLOOD  PRODCUTS  A/C  BPAC  9/10/08,  7/27/10,  4/29/1 1 

03/15/2013 

ALFB/ 

BAYER,  RICHARD 

2013-564 

01/24/2013 
02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  V_/  III    /  t — /  1  ]  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ROXANNE  OZAWA 

1  l  V^/  / \l  \  1  x  1  V|  1   Vw /  £.  1  \  V  V  1  \ 

AFFYMAX  INC 

AUDREY  GUREVICH  ST  PETERSBURG  MEDICAL  ACADEMY 

/  \  V/  IS  1  1 1        1     Vwl  Vw/  1  1 1       V  1  Vw/  1   1  ,    VJ  1     1     1       1  1  1  I  V_/  IS  V/  1  I  Vwi    1  v  1  1  lw/  1  V_/  /  V  L_  f  \  \  '  l  \  \ — '  \  1  V 1  1  , 

ST  PETERSBURG,  RUSSIA  -  EIR  12/1 1 

2013-565 

01/24/2013 
02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \S  IS  1  1   If  Vw/  III    /  !_/  1  J  /  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      1  /  \J  IS  1  1  1/  > — /  III    /  IS  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

ROXANNE  OZAWA  COULON 

1  l  V^/  /  VV  \  1  x  1  V|  1   Vw /  £  /  V  V  V  / x   \S  V_/  Vw*  L—  Vw /  1  VI 

AFFYMAX  INC 

DR  KONSTATIN  GUREVICH  ST  ELIZABETH  CITH  HOSPITAL 

\S  1   l    1  V  V^/  1  >J  V/  1  1  \  1  II  v    Vwi  V/  1  1 1       V  1  Vw/  1   1  j    V/  1  1— —  l_  1 L  I  \  IS  1       1  1   1    Vw/  1  1  1   1    II  Vw/  V/  1     1  1  /  \  1— . 

ST  PETERSBURG,  RUSSIA  -  483,  EIR  11/1 1 

2013-566 

01/24/2013 

W  1  /  £—  TV  L.U  1  U 

02/22/2013 

FDA/OGROP/ORA/PA-FO/SAN- 

1    IS  1  \!  Vw/  V/  1   I  V_/  1    /  Vw/  1   It  \/  1    / \    1    Vw//  V/ 1  \  1  VI 

DO/SAN-CB/ 

ROXANNE  OZAWA  COULON 

1  1 V-/  / \/  \  1  V|  1  V|  1   Vw /  £  /  V  V  V  1  \   \Sf  V/  \S  L_  Vw /  1  VI 

AFFYMAX  INC 

AFFYMAX  INC  PALO  ALTO  CA  -  EIR  10/11 

i  \  ii    ii  vi/  \/  \  1 1  *j  \w/ ,  i   y  \  i_  Vw/  i  \  \     i  Vw/ .  Vw/  /  v      i_  iii    i  v//  i  i 

2013-567 

01/24/2013 
02/22/2013 

FDA/OGROP/ORA/SE-FO/FLA- 
DO/FLA-CB/ 

ROXANNE  OZAWA  COULON 
AFFYMAX  INC 

EDOUARD  MARTIN,  MD,  FLORIDA  RESEARCH  INSTITUTE, 
LAUDERDALE  LAKES,  FL  -  483,  EIR  9/1 1 

201 3-568 

01/24/2013 
02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  •  1  \i  Vw/ 1 V  1 1      1  /  V/  1— /  1  1  1/  V_/  III    /  !_/  1  L/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

DAVID  L  ROSEN 

IS  f  \  V  1  lw/    1  1   1  V  1  \_}  1  |  M 

FOLEY  &  LARDNER  LLP 

SOFGEN  PHARMACEUTICALS  -  PROGESTERONE  ORAL 

ov/i   <wi  i  i  n  i    i  i  r\  \  \\v\r\\-j\  \j  i  i  v_/ 1  \  i  \s      i    i  \  Vw/  \s\  i  -s  i  i  i  iwi  "ii      Vw/ 1  ini  

CAPSULES  ANDA  200456 

2013-569 

01/24/2013 
02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    IS  1  \!  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  Vw/  III    /  IS  1  lw/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1          IS  1      \l    Vw/  1  V  1   1             1     /    Vw/  lw/    1            |       If    V_/  III         /     |w/   1   lw/   1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DAVID  L  ROSEN 

IS  1  \  V  1  lw/    1  .    1   1  V  >  \_>  1  |M 

FOLEY  &  LARDNER  LLP 

TEVA  PHARMACEUTICALS  -  PROGESTERONE  ORLA 

1  1       V  1  \    A     1   1 1  \  1  1 1 V II  \\S  1  VJ  1  1  \Zr\l  Vw/        1     1  l V  '  '^S  1  Vw/  1  1  1  l Vw/ 1  N  1        \s  1  1 1  1  \ 

CAPSULES  SBA  ANDA  202121 

2013-570 

01/24/2013 

v/   1  /  L —    T/  L —  V/   1  U 

02/22/2013 

FDA/OF/CFSAN/OCD/EOS/ 

FREDERICK  A.  STEARNS 
Keller  and  Heckman  LLP 

NONO  LABORATORIES  INC  GRASP  5G0297 

2013-571 

01/24/2013 
02/22/2013 

FDA/OF/CFSAN/OCD/EOS/ 

KELLY  STAROSTA  HILL 
Keller  and  Heckman  LLP 

STARLINGER  &  CO  -  NOL  160 

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2013-572 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

BENJAMIN  L.  ENGLAND,  Esq. 

BENJAMIN  L  ENGLAND  & 
ASSOCIATES  LLC 

SILVERLON  -  CONTACT  WOUND  DRESSING  K981299; 
WOUND  PACKING  STRIPS  K984210 

2013-573 

01/24/2013 
02/22/2013 

FDA/OGROP/ORA/NE-FO/NWE- 
DO/NWE-CB/ 

FDA/OMPT/CDRH/OCER/DFOI/ 

TIMOTHY  P.  COON,  Esq. 
WILK  AUSLANDER 

CORR  BETWEEN  FDA  &  MIRA  INC  9/1 1  TO  1 2/1 2 

2013-574 

L_  \J    1  \J    v/  /  i 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

1    L/  1  \l  Vw/  1 V  1  1      11  \J  l—s  1  11   1/  Vw/  V  '  l_  1  1/  1  /  1    Vw/  1/ 

BORIS  REYDEL  MD 

1  f  V  '  1  1  1 V/    1  1 1— —  1   1  J  1  1  h  IVIL*/ 

INVENTIO  LLC 

K1 12698 

1  V  I    1  L— 

2013-575 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

BORIS  REYDEL,  MD 
INVENTIO  LLC 

K1 12698  UNREDACTED 

2013-576 

01/24/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  /  V/  Vw/  1  v  1  1      1  /  V/  L/  1  1  1/  \w/  III    /  1—/  1  l_/  1  / 

KATE  PURCELL 

1  \  I  \  1  l—    1     V/  1  l  Vw/  1  1  l_ 

MINIVELLE  NDA  03-752  SBA 

1  V  1  1  1  N  1  V  1       1  1  1         1  M  1  /  1  V    \J  \J     1        L_    V/  I—/ 1  \ 

02/22/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  Vw/  1  v  1  1      1  /  Vw /  L/  1  1  1/  V_/  III    /  t — '  1  l_/  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

DOCUTRIEVAL  INFORMATION 
SERVICES 

2013-577 

01/24/2013 

FDA/OGROP/ORA/SE-FO/FLA- 

1    ]  /  /  V/  Vw/  \J  1  1 V-/  1    /  Vw/  1  1/  V/       l__    1    Vw//  1    l_/  V 

PATRICIO  TD  BARRERA 

1    i  \  1  1  l  1  V/  1  V/     1  ■  L/  ■    I—/  /  V 1  11  1 1  1  I  / \ 

KRAMER  LABORATORIES  INC  -  EXHIBITS  ATTACHMENTS 

1  \  1   11  11 V  1  1— —  1  l    l—l  \  1  /  V_/  1  In  1  Vw/  1  1 1  1  O    1  1  M  \J        1  /  V  L   II  1  '  1  1  v/  3    / \  1     1  / \  V/  1   1  1  V 1  1  1  N  1  V/ 

02/22/2013 

DO/FLA-CB/ 

BARRERA  &  ASSOCIATES 

2013-578 

01/24/2013 

CVM/OCD/ 

GABRIEL  SCOTT 

DCK  FDA  2011-N-0899 

02/22/2013 

OM/OMP/DODM/ 

CASCADIA  WILDLANDS 

2013-579 

01/24/2013 
02/22/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

□  n  a  n  i — /~\  n      n   i  / i  a  /~*  i —  n 

BRADFORD  P.  KLAGER 

LAW  OFFICES  OF  DOUGLAS  A 
ALLISON 

Ml  GWANG  POLYMACON  CONTACT  LENSES  -  CORR 

2013-580 

01/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Javier  Collazo 

K071560 

02/25/2013 

FDA/OC/OES/DFOI/ 

RespCare 

2013-581 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Francine  Vera 

Francine  Vera  -Towne,  Ryan  & 
Partners  PC 

NOVASURE  INPEDANCE  CONTROLLED  ENDOMETRIAL 
ABLATION  SYSTEM  -  MANUALS,  INSTRUCTIONS,  TRAINING 
ETC 

2013-582 

01/25/2013 
02/25/2013 

CVM/OCD/ 

Application  document  for  animal 
drun  u^inn  nitpnnvram 

SUMITOMO  CHEMICAL  CO  LTD 

NITENPYRAM  -  APPROVAL  RECS 

2013-583 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/CE-FO/PHI- 

1    1  /  1  \!  Vw/  V/  1   I  V_/  1    /  Vw/  1  1/  V/  w  l_    1    Vw//  1  III 

DO/PHI-CB/ 

fipnp  Partin 

VJ  \J  1  1  vZ    1     CI  1  LI  1  I 

ZOLL  Lifecor  Corporation 

ZOLL  LIFECORE  CORPORATION  -  EIR  EXHIBITS  (08/28/2001 

L  \—S  1  1       1  1  1    l_  V/  V/  1  1 1—    Vw/  Vw/  1  11     Vw/  1  1 V  \  1  1  Vw/  1  >l        l_  1  1  I    ^_/\  1   1  1  I  >  1  1  V/    1  vU/  £_  V//  l_  W  V/  1 

-08/28/2001) 

2013-584 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Azuka  L.  Uzoh 

Law  Office  of  Azuka  L.  Uzoh 

TEVA  PARENTERAL  MEDICINES,  INC,  IRVINE,  CA  -  EIR,  483, 
SHUTDOWN  ORDERS  (08/02/2007  -  07/31/2010)  (CERTIFIED) 

2013-585 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Maria  Makarich 

OXARBAZEPINE  300/5  SUSPENSION  -  BIOEQU I  VALENCE 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Makarich,  Maria 

DATA 

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Reed  Date  / 
Due  Date 

Action  Office 

Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

O  A  H  O  ETO  A 

^013-586 

AH  /OIT  /OA  -t  O 

01Ai5/^01o 
02/25/2013 

rUA/UuKOr/UKA/bt-r(J/A  1  L- 
DO/ATL-CB/ 

Sandy  Stagge 

CTI  Clinical  Trial  &  Consulting 
Services 

Ah/I^l   IA    1    A  M/~»  OT^M     ATI    AMTA     /"»  A       A  OO  nCOnAMOC 

AMtLIA  LANub  1  ON,  A 1  LAN  1  A,  (jjA  -  48o,  KtbrUNbt 
(08/01/2006-  10/01/2006) 

2013-587 

01/25/2013 

ORA/ 

Thprpqo  Thomncnn 

1  1  1  w  1  ^  O  CA     1  1  1  \J  1  1  IUOUI  1 

MEDICAL  DEVICE  AND  RAD  HEALTH  RECALL  EVENTS 

1 V  1  1  IS  1  Vw/ 1  \  l_    i_y  1       v  1  V_y  1        /  VI  \  l_/    1  1 7  \  L-/    1   1  1_  /  V  L_  1  1   1    1  I  1  \_/  1  \  1  1       1       V  1  111  \J 

02/25/2013 

ORA/ 

ORA/OE/ 

ORA/OE/ 

UIC  c/o  Theresa  Thompson 

2013-588 

01/25/2013 
02/25/2013 

FDA/OF/CFSAN/OCD/EOS/ 

LaVeeta  Moten 
LaVeeta  Moten 

NOTICE  RE  WORK  ON  LAPTOPS  FROM  COLLEGE  PARK 
DESKTOP  SUPPORT 

1  /  1  \-)  \  \  1  Vw/  1       V-/  Vw^  1     1     \w/  1  I  1 

2013-589 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/SE-FO/NOL- 
DO/NOL-CB/ 

Sandy  Stagge 

CTI  Clinical  Trial  &  Consulting 
Services 

JEFFREY  SOSMAN,  MD  -  483,  RESPONSE  (09/01/2010  - 
12/01/2010} 

1  L—l  \J    1  /  L—\J    1   \J  f 

2013-590 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

K041 71 1 

2013-591 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/GE-FO/MIN- 
DO/MIN-CB/ 

Jens  Saakvitne 

South  Dakota  Lions  Eye  and  Tissue 
Bank 

i  II —  i —  o  /"n  i  inr^r    n  a  i  m  m  ^  a  n/"M  i  o    a  im     *ioo  /ah  /ah  /on  h  h 

LIFEbOURGE,  MINNEAPOLIb,  MN  -  483  (01/01/201 1  - 
12/31/2011) 

2013-592 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  1  \!  \w/  1  v  1  1      1  /  \w/  L/  1  1  1/  \-s  III    /  I — /  I  l_/  I  / 

Kathprinp  fiiannamnrp 

1  \d  1 1  1  \s  I  II  1              1  CI  1  1 1  1  CI  1  1  1 W 1 

ANDA  074731 

i  vi  i_ ft  v  \_/  /  nr  /  kj  i 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Office  of  Katherine 
Giannamore,  P. A. 

2013-593 

01/25/2013 
02/26/2013 

CVM/OCD/ 

FDA/OGROP/ORA/CE-FO/CIN- 
DO/CIN-CB/ 

FDA/OGROP/ORA/SW-FO/DAL- 
DO/DAL-CB/ 

FDA/OGROP/ORA/PA-FO/LOS- 
DO/LOS-CB/ 

Jeffrey  Jones,  Counsel  for  The 
Scotts  Miracle-Gro  Company 

The  Scotts  Miracle-Gro  Company 

SCOTT'S  MIRACLE  GRO  COMPANY  -  TESTING  RE  HARM  TO 
BIRDS,  WILD  BIRD  FOOD,  ETC 

2013-594 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rebecca  Walters 
AtriCure  Inc. 

K101961,  K1 1 1 064 

2013-595 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Katherine  Giannamore 

ANDA  075357 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Office  of  Katherine 
Giannamore,  P. A. 

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Signature/  Requester 

Subject 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-596 

01/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Katherine  Giannamore 

AN  DA  074924 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Office  of  Katherine 
Giannamore,  P. A. 

2013-597 

01/25/2013 
02/25/2013 

OM/OMP/DODM/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

Bijal  Pandhi 

NOVARTIS  PHARMACEUTICAL 
CORP 

SALMON  CALCITONIN  -  ENDOCRINILOGIC  AND  METABOLIC 
ADVISORY  COMMITTEE  MATERIALS  1991,  1994 

2013-598 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Katherine  Giannamore 

AN  DA  074588 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

Law  Office  of  Katherine 
Giannamore,  P. A. 

2013-599 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/CE-FO/DET- 
DO/DET-CB/ 

Hillary  M  Estes 
NESTLE  USA  INC 

NESTLE  USA,  ANDERSON,  IN  -  EIR  (05/14/2010  -  11/05/2010) 

2013-600 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Javier  Collazo 
Respacare 

K1 02404 

2013-601 

01/25/2013 
02/25/2013 

FDA/OGROP/ORA/CE-FO/CHI- 
DO/CHI-CB/ 

Jeri  Hill 

DMS  Holding,  Inc.,  Dba/Briggs 
Healthcare 

DMS  HOLDING,  INC  DBA  BRIGGS  HEALTHCARE, 
WAUKEGAN,  IL  -  EIR  (6/1 5/201 1  -  06/1 6/201 1 ) 

2013-602 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Anthony  Lenza,  Esq. 
Amabile  &  Erman,  P.C. 

265782,  10455-10-2002-00021,  1045510-2002-00027  ETC - 
MAUDE  REPORTS  AND  INVESTIGATION  RECS 

2013-603 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Sandy  Stagge 

JOHAN  MAERTENS,  BELGIUM  -  EIR  (06/01/2004  -  08/30/2004) 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

CTI  Clinical  Trial  &  Consulting 
Services 

2013-604 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Rachel  Johnson 
FOI  Services,  Inc. 

FDA  RESPONSE  TO  06/28/2001  LETTER  FROM  INTUITIVE 
SURGICAL 

2013-605 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Rachel  Johnson 

UQUIFA,  SPAIN;  UQUIFA,  MEXICO  -  EIR,  483,  WARNING 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FOI  Services,  Inc. 

LETTER, ETC 

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FDA/OMPT/CDER/ORP/DIDP/ 

2013-606 

01/25/2013 
02/25/2013 

FDA/OC/OES/DFOI/ 

DARREN  L  BROWN 

PROVOST  UMPHREY  LAW  FIRM 

DR  ERIC  WILHELMSEN,  WILHELMSEN  CONSULTING  - 
GUIDANCE  LTR  ON  INGREDIENT  DECLARATION  FOR 
VAnlUUb  oWtt  1  bNbrib  o/o/UU,  HILLbL  b  HUdcH  1  b, 
UPSCALE  FOODS,  INC  -  WARNING  LTR  11/15/04,  ETC 
(CERTIFIED) 

2013-607 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

BUSPAR  (BUSPICONE  HCL)  -  MARKETING,  SALES,  MFG 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

BRYAN  #254638,  T  TERRELL 

RECS 

2013-608 

01/25/2013 

FDA/OC/OES/DFOI/ 

REO  TANOSHIMA  MD 

KEPPRA  (LEVETIRACETAM)  -  AERS 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

HOSPITAL  FOR  SICK  CHILDREN 

2013-609 

01/25/2013 
02/25/2013 

VIELHABER,  LINDA 

SAFETY  RPT  #1027508 

2013-610 

01/25/2013 
02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

AMY  TAYLOR 
INFOTRIEVE  INC 

GUIDANCE  FOR  CLNCL  EVALUATION  OF  COMBINATION 
ESTROGEN/PROGESTIN-CONTAINING  DRUG  PRODS 

2013-611 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

CHRISTOPHER  L  ROBINSON 
MORRISON  &  FOERSTER  LLP 

LEPU  MEDICAL  TECHNOLOGY  (BEJING)  CO  LTD  -  RADIAL 
ARTERY  COMPRESSION  TOURNIQUET  K1 1 1837 

2013-612 

01/25/2013 
02/25/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Jason  DeYoung 

WESTERN  MICHIGAN 
UNIVERSITY 

FOOD  AND  BEVERAGE  FIRMS  IN  Ml,  IN,  OH  -  COMPANY 
NAMES,  CONTACT,  EMAIL  ETC 

2013-613 

01/25/2013 

ORA/ 

PETER  D  WEINSTEIN  ESQ 

INFUPHARMA  LLC,  HOLLYWOOD,  FL  -  INVESTIGATION  RPT 

02/25/2013 

ORA/ 

COLE  SCOTT  AND  KISSANE 

1/17/12 

2013-614 

01/25/2013 
02/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

CAROL  NAKAGAWA 
MERGE  HEALTHCARE 

AYCAN  DIGITALSYSTEME  GMBH  -  AYCAN  MOBILE  K1 22260 

2013-615 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

ARIANNA  OBERMEIER 

ORANGE  BOOK  -  EXCLUSIVITY  AND  PATENT  FILES 

02/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

FLORIDA  BLUE 

2013-616 

01/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

RENAE  N  FEO 

JARIT  ENDOSCOPES  K944870 

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02/25/2013 

INTEGRA  YORK  PA  INC 

2013-617 

01/25/2013 

FDA/OF/CFSAN/OCD/EOS/ 

CRYSTAL  SPIVEY  WILDEMAN 

MEAD  JOHNSON  NUTRITION  CO  -  ENFAMIL  PREMIUM 

09/17/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 
DO/DET-CB/ 

KAHN  DEES  DONOVAN  &  KAHN 
LLP 

INFANT  ENFAMIL  GENTLEASE  ENFAMIL  AR  RECS  2009  TO 

1  1  >l  1    1  V 1  *J  1  „    l_  1  M  1    1  \  1  V  1  1  L-   \-A  1—  1  *J  1  1  1  1  \  \-J  1—  i    1  1  *J  1    /  VI V  1  1  1—  /  V 1  1    1  1 1— —  VJ  U   £—  V/  \J  \J     1  Vw/ 

PRESENT 

2013-618 

01/25/2013 

FDA/OGROP/ORA/NE-FO/NWE- 

STEPHEN  D  ELLIS 

AADCO  MEDICAL  INC,  RANDOLPH,  VT  -  EIRS,  WARNINGS, 

02/25/2013 

DO/NWE-CB/ 

ELLIS  BOXER  &  BLAKE  PLLC 

REGISTRATIONS,  ETC 

2013-619 

01/25/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

KATHERINE  STRONG  CARNER 

OFFICE  OF  IN  VITRO  DIAGNOSTIC  DEVICE  EVALUATION 

02/25/2013 

SIDLEY  AUSTIN  LLP 

AND  SAFETY  (OIVD)  -  UNTITLED  LTRS  SENT  TO  A  CLNCL 
LAB,  LAB  SELLING  ANALYTE  SPECIFIC  REAGENTS  (ASR), 
ETC 

2013-620 

01/25/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    l  /  /  V/  Vw/  1  v  1  1      1  /  V  '  L/  1  1  1/  > — /  III    /  1 — /  1  L/  1  / 

MAXZIDE  NAPROXEN  NIFEDIPINE  ETC  -  RECS 

1  V  It     \  /  V^_  1  lw/  l_  ,       1    *l  I    \  1        1     VV//\  1         1    1^       1    >l  1  1        1         1  /  II        1  1    N  1         q       1            1     Vw/              1     I  1— —  Vw*  V/ 

uu  c-\Jl  C\J  1  O 

FDA/DMPT/nnFR/nRP/ninp/ 

i  \—jf\/  v_/ivi  r  i  /  \j  \-J  \  ri/  v_/  1 1 1  / 1_/ 1 i_/ 1  / 

FDA/OMPT/CDER/ORP/DIDP/ 
FDA/OMPT/CDER/ORP/DIDP/ 

ARFRF  #285447  I  |M|  II  A  R 

r\  LJ 1  LJ 1      Tt£-\J*J^^I  ,  Ul  NULn  U 

2013-621 

01/25/2013 

FDA/OGROP/ORA/CE-FO/CIN- 

JOHN  D  HENDERSON 

SOUTHERN  STATES  CAMPBELLSVILLE  SERVICE, 

02/25/2013 

DO/CIN-CB/ 

JOHN  D  HENDERSON  PSC 

CAMPBELLSVILLE,  KY,  HARGIS  TRUCKING  INC,  COLUMBIA, 
KY  -  DELIVERY  OF  UREA  CONTAMINATED  FEED  TO  SMITH 

1 —  A  nil  AO    HO  lf\(~\ 

FARMS  12/09 

2013-622 

01/25/2013 

FDA/OF/CFSAN/OCD/EOS/ 

MARSHA  GREEN 

RAW  CLOVER  SPROUTS  E  COLI  OUTBREAK  AT  JIMMY 

02/25/2013 

FDA/OGROP/ORA/CE-FO/CIN- 

DANIEL  POWELL  &  BREWER  LLC 

E/~\l_l  M'O  Dl —  O  ~~V  A  1  inAMTO             / 1 —  O  ~~V  1 Z^1  A  ~T  1  f~\  K  1  r- )  1 —      O    HO  /OC  /H  H  ~T/™\ 

JOHNS  RESTAURANTS  INVESTIGATION  RECS  12/25/11  TO 
3/3/1 2 

DO/CIN-CB/ 

FDA/OGROP/ORA/SE-FO/NOL- 

DO/NOL-CB/ 

F  D  A/OG  ROP/O  RA/S  W-  FO/KAN- 

DO/KAN-CB/ 

2013-623 

01/25/2013 

FDA/OGROP/ORA/PA-FO/LOS- 

BRENDA  M  GARTZ 

1  '  1  1 1__  1  N  1  / 1  \   1 V  1    \-A  1  VI  1  1  L  

SYNERGY  HEALTH  SAN  DIEGO  CA-EIR2/12 

\J  1  1  *J  1  1   1  > — A   1     1   1  I  1  \  \       1   1    1  ,    \—J  1  \  \  il  1 — /  1  l_  V_/  Vw/  .    \w/  /\        l_  II  1   l_  /   1  L- 

02/25/2013 

DO/LOS-CB/ 

ELI  LILLY  &  CO 

1  1  1    1  II  1       1     VA   Vw/ Vw/ 

2013-624 

01/25/2013 

FDA/OGROP/ORA/CE-FO/CHI- 

1    ]  /  /  V/  Vw/  \J  1  1 W  1    /  \w/  1   It  \/  K-J  1—    1    Vw//  V^/  1   1  1 

BRENDA  M  GARTZ 

l—)  1  1 1_  1  N  1  /  1  \   1 V  1    \-A  1  VI  1  1  c.  

ANDERSON  PACKAGING  ROCKFORD  IL  -  EIR  4/18/12 

/  VI  M  1  >  \  1  1  V»J  Vw /  1  M    1     1  \  \_/  1  \/  \       1  1  *l  V_-1  1    1  I  Vw/  Vw/ 1  V  1    Vw/  1  I  lw/  ,    1  L_        1  111           1  \Jl    1  L_ 

02/25/2013 

DO/CHI-CB/ 

ELI  LILLY  &  CO 

2013-625 

01/25/2013 

FDA/OGROP/ORA/SW-FO/KAN- 

1  1 — '  1  \l  \w/  vy  1   1 V_/  1    /  v-/  1  1/  V/  V*/  V  V     1    \*//  1  \/ VI  ^1 

BRENDA  M  GARTZ 

1 — '  1  1 1_  1  N  1  / 1  \   1 V  1    \-A  1  VI   1  1  t-  

APTUIT  INC  KANSAS  CITY  MO  -  EIR  3/24/10 

/  V 1      1  Vw/  II     II  il  V-/  j    1  V/  VI  N  \-J  t\\-J    W  II     l?    1 V  1  Vw/        1  1  1  1  \Ji  L—  i^l    1  \_/ 

02/25/2013 

DO/KAN-CB/ 

ELI  LILLY  &  CO 

l_  l_  1    E  1  E  E       1     VA    Vw/  Vw/ 

2013-626 

t—\J    1  \J     \J  L—\J 

01/25/2013 
02/25/2013 

FDA/OC/OES/DFOI/ 

1    1— Vw/  Vw//  Vw/  1 —  VJ/  L-f  1    Vw/  1/ 

JOHNATHAN  RICKMAN 

\J  Vw/  1   1  1  N I  \  1  1   1 1  \  1*1    111  Vw/  1  V 1  V  1  /  \  1  N 

FDA  NEWS 

FOI  DAILY  LOG  1/7-11/13 

1    Vw/ 1  1 — /  /  VI  1       1     LWV/     III       1    1  /    1  U 

2013-627 

01/25/2013 

FDA/OF/CFSAN/OCD/EOS/ 

JOHN  R  ERICKSON 

CFSAN  CANCER  ASSESSMENT  CIMMITTEE  MEMO  CAP 

02/25/2013 

BASF  CORP 

9C0096  4/21/89 

2013-628 

01/28/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Melissa  Hirst 

NURSERY  WATER,  WELL  WATER  -  TESTING  RECS; 

Page  249  of  895 


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02/26/2013 

F  D  A/OG  ROP/O  RA/C  E-  FO/D  ET- 

JONES  DAY 

COMPLAINT;  ETC 

DO/DET-CB/ 

FDA/OGROP/ORA/SE-FO/ATL- 

DO/ATL-GB/ 

FDA/OGROP/ORA/PA-FO/LOS- 

DO/LOS-CB/ 

FDA/OC/OES/DFOI/ 

FDA/OGROP/ORA/SW-FO/KAN- 

DO/KAN-CB/ 

2013-629 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1—/  1  L/  1  / 

Chri^  Cnnn 

\Jl  II  IO    V/Ul  lU 

NORLESTRIN  21  2  5/50  -  MEDICAL  OFFICER  REVIEW  AND 

1  M  Vw/  1  1  L_  1  V/  1  1  1 1  1  VI    1—  1     L_  ■  v//  v/  V/        1  V 1  1  1  >  1  WML  Vw/  1     1     1  V/  l_  1  1    1  1 1       V  1  1— —  V  V    1  V 1  M  1  / 

02/26/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Agile  Therapeutics 

OTHER  REVIEWS 

FDA/OMPT/CDER/ORP/DIDP/ 

FDA/OMPT/CDER/ORP/DIDP/ 

2013-630 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

michele  hong 

NDA  21366  S10 

02/26/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  \w/  1  v  1  1      1  /  V  '  L/  1  1  1/  \w/  III    /  1 — '  1  IS  1  / 

mirhplp  honn 

1 1  1 1 \j i  1 17 iu  i  ivji  iu 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  / V/  Vw/ 1 V  1 1      1  /  V/  l_/  1  1  1/  W  III    /  IS  1 1  '  1  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1  1 — '  /  V/  \w/  1  v  1  1      1  /  V/  IS  1  1  1/  V_/  III    /  t — '  1  J  /  1  / 

OM/DDM/ 

2013-631 

01/28/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Chri<;  Lahiff 

\  '  1  J  1  1  O    1  Cl  1  1 1  1  1 

CONTAMINATED  DRIED  FRUITS  -  ADVERSE  EVENTS 

V*/  Vw/  1  M  1  /  V 1 V 1  1  1  N  1  \  1  1  1 — '    IS  1  1  1  1  1  /    III  V/  1  1  Vw/        /  V  L/  V  1— —  1  1 V/  1— —    1       V  1  1  V  1  V/ 

Uu  C\jl  C\J  1  O 

MrDprmntt  Will  &  Fmprv  1  1  P 

IVIOL^CIIIIULl  Will  CX  1  1  1  1  CI  y   !_ I_ \ 

(01/01/2000-01/25/2013) 

201 3-632 

01/28/2013 

ORA/ 

.  lanirp  M  R1771 

Jul  ll^d    1 V 1  .    1  \\t-t—\ 

CONSUMER  COMPLAINT  129691 

V/  Vw/  1  N  V  '  V/  1 V  1  1  1  1    Vw/  Vw/  1 V  1  1              1  1  N  1       1  1 

02/26/2013 

ORA/ 

Radagast  Pet  Food,  Inc. 

2013-633 

01/28/2013 

FDA/OMPT/CDRH/OCER/DFOI/ 

Curtis  Obert 

RADIATION  EMITTING  MACHINES  IN  HOSPITALS  -  NUMBER, 

02/26/2013 

CASE  WESTERN  RESERVE 

INSTALATION 

1  1  M  V/  1  1  V  l_/  V  1  1  \S  1  N 

UNIVERSITY 

2013-634 

01/28/2013 

FDA/OGROP/ORA/SE-FO/ATL- 

Brian  Roemer 

GATE  GOURMET  -  CONSUMER  COMPLAINT  RECS 

02/26/2013 

DO/ATL-CB/ 

Gate  Gourmet 

2013-635 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

1    1  /  /  V/  Vw/  1  v  1  1      11  \  '  L/  1  1  1/  > — /  III    /  1 — '  1  1  /  1  / 

Chri^  Oano 

\J\  II  IO  * — ' CA 1  IU 

NORLESTRIN  21  1/50  -  MEDICAL  OFFICER  REVIEW 

1  M  Vw/  1  1  L_  1  Vw/  1  1  1 1  1  VI    L_  1      1  /  S  V/        1  V 1  1  IS  1  V/  /  V  L_  \  '  1     1     1  Vw/  1  1  1    1  1  1       V  1  1      V  V 

02/26/2013 

FDA/OM  PT/CD  E  R/OR  P/D 1  DP/ 

1    !  '  / V/  Vw/ 1 V  1 1      1  /  V/  IS  1  1  1/  V_/  III    /  L/  1  IS  1  / 

Anilp  Thpranpi itirQ 

FDA/OMPT/CDER/ORP/DIDP/ 

i  i — '  /  v/  v/ 1  v  1 1     i  /  v/ 1_/  i  i  i/  w  ill   /  i — *  1 is  i  / 

FDA/OMPT/CDER/ORP/DIDP/ 

1    L/  / V/  V/  1 V  1 1      11  W  L/  1  1  1/  V/  III    /  !_/  1  L/  1  / 

2013-636 

i. —  V/  1  V/  \J\J\J 

01/28/2013 

FDA/OF/CFSAN/OCD/EOS/ 

Zoi  Pannavianni^ 

MOLYBDENUM,  NICKEL,  COBALT,  VANADIUM,  AND 

02/26/2013 

N/A  (CONSUMER) 

STRONTIUM  IN  TOTAL  DIET 

2013-637 

01/28/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

Jennifer  Brown 

PLACEBO-CONTROLLED  CLINICAL  TRIALS  DATABASE  FOR 

02/26/2013 

FDA/OMPT/CDER/ORP/DIDP/ 

INFOTRIEVE  INC 

SUICIDALLY  AND  PREPARING  DATA  SETS  FOR  ANALYSIS 

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