Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 1 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
NURSERY WATER, WELL WATER - TESTING RECS; COMPLAINT; ETC
NORLESTRIN 21 2.5/50 - MEDICAL OFFICER REVIEW AND OTHER REVIEWS
NDA 21366 S10
CONTAMINATED DRIED FRUITS - ADVERSE EVENTS (01/01/2000 - 01/25/2013)
CONSUMER COMPLAINT 129691
RADIATION EMITTING MACHINES IN HOSPITALS - NUMBER,INSTALATION
GATE GOURMET - CONSUMER COMPLAINT RECS
NORLESTRIN 21 1/50 - MEDICAL OFFICER REVIEW
MOLYBDENUM, NICKEL, COBALT, VANADIUM, AND STRONTIUM IN TOTAL DIET
PLACEBO-CONTROLLED CLINICAL TRIALS DATABASE FOR SUICIDALITY AND PREPARING DATA SETS FOR ANALYSIS BY FDA - DRAFT GUIDANCE
MANUKA HONEY, WEDDERSPOON ORGANIC - REPORTS,
Melissa Hirst
Chris Cano
michele hong
Chris Lahiff
Janice M. Rizzi
Curtis Obert
Brian Roemer
Chris Cano
Zoi Pappayiannis
Jennifer Brown
Travis J. Jacobs, Esq.
JONES DAY
Agile Therapeutics
michele hong
McDermott Will & Emery LLP
Radagast Pet Food, Inc.
CASE WESTERN RESERVE UNIVERSITY
Gate Gourmet
Agile Therapeutics
N/A (CONSUMER)
INFOTRIEVE
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
2013-628
2013-629
2013-630
2013-631
2013-632
2013-633
2013-634
2013-635
2013-636
2013-637
2013-638
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
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/OF/CFSAN/OCD/EOS/
ORA/
ORA/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
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/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OM/OMP/DODM/
FDA/OF/CFSAN/OCD/EOS/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 2 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
TEST RESULTS, APPLICATION, ETC (01/01/2005 - 01/25/2013)
SCOTTS MIRACLE GRO - CORR WITH FDA RE RECALLS; TELEPHONE CALLS
POST DONATION FATALITY REPORTS
VERIDEX - CELL TRACKS AUTO PREP SYS K122821; K110406; K100684; IMMUNICON - CELL TRACKS AUTO PREPSYS K040077
ARIAD PHARMACEUTICALS - RIDAFOROLIMUS SPA
FOOD LBLG POLICY REGARDING HUMAN FOOD 9/11 TO PRESENT
SHAKER DAKHIL, CA CTR KANSAS, WICHITA, KS - 483 3/12 TO PRESENT
SALMONELLA, E COLI, LISTERIA AT FOOD FACILITIES - 483S
APEX ENERGETICS INC, IRVINE, CA - RECS
ARMEN SIMONIAN, ORANGE COUNTY, CA - RECS
BLOOD NUTRITION INSTITUTE INC, SANTA ANA, CA - RECS
PRINCIPAL LAB INC, SANTA ANA, CA - RECS
HEALTH SCIENCES INVESTMENT GROUP, PHOENIX, AZ - RECS
ARMOND SIMONIAN, ORANGE COUNTY, CA - RECS
Jason A. Forge
Mary Gustafson
ERAN BEN-TAL
ELLIOTT FAVUS, M.D.
PATRICIA L. REGENYE
MARY CLARE JALONICK
The Jacobs Law, LLC
Robbins, Geller, Rudman & Dowd
PLASMA PROTEIN THERAPEUTICS ASSOCIATION
BIOCEP LTD
FAVUS INSTITUTIONAL RESEARCH LLC
GREENBERG, BEATRICE .
Celgene Corporation
ASSOCIATED PRESS
ZIMMERER, CHARLES
ZIMMERER, CHARLES
ZIMMERER, CHARLES
ZIMMERER, CHARLES
ZIMMERER, CHARLES
ZIMMERER, CHARLES
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
2013-639
2013-640
2013-641
2013-642
2013-643
2013-644
2013-645
2013-646
2013-647
2013-648
2013-649
2013-650
2013-651
ORA/
ORA/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
CVM/OCD/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
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/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
ORA/OE/
ORA/OE/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 3 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
CYREX LABORATORIES LLC, PHOENIX, AZ - RECS
BLOOD NUTRITION SOFTWARE INC - RECS
AMBIEN (ZOLPIDEM) - AERS
AMOUNT OF 14 HYDROXYCODEINONE PERMITTED IN OXYCODONE HCL ACTIVE PHARMACEUTICAL INGREDIENT (API) - RECS
HEMOCCULT TEST FOR RECAL OCCULT BLOOD
CORR BETWEEN FDA COMMISSIONER, THE DEPUTY COMMISSIONER FOR FOODS AND VETERINARY MEDICINE, IVACARE CORP
FELINE HAIRBALLS; FELINE UNIARY TRACT HEALTH - LBLG, NO OBJECTION LTRS
ENTRY NO AV300383518
PFIZER INC - ZOLOFT WARNING LTR 8/1/96
LAURA HOBBS
NANETTE CANEPA
ABRAHAM PAYTON
DAN ASHE
DOUGLAS N. BLUE
COLEEN KLASMEIER
ZIMMERER, CHARLES
ZIMMERER, CHARLES
HOBBS 134225, BRIAN
LEXIS NEXIS COURTLINK INC
BECKMAN COULTER INC
AMERICAN BRIDGE 21ST CENTURY
PATTERSON BELKNAP WEBB & TYLER
PATTERSON BELKNAP WEBB & TYLER
SIDLEY AUSTIN LLP
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
2013-652
2013-653
2013-654
2013-655
2013-656
2013-657
2013-658
2013-659
2013-660
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-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/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/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OC/COS/OL/
OC/OCC/
ORA/
ORA/
CVM/OCD/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 4 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
ABBOTT LAB V797P-5057B; ELI LILLY V797P-2237D; GENENTECH V797P-5067B
AZO GESIC; AZO SEPTIC; AZO STANDARD - AER 2005 TO PRESENT
VENOFER AER
SIMPLY THICK - NECROITIZING ENTEROCOLITIS INSP, RPTS, CORR 1/10 TO PRESENT
WYETH LABORATORIES INC, PFIZER INC - 483S, WARNING LTRS; EFFEXOR XR LBLG CHANGES, FINES, ETC
JK SUCRALOSE INC, EDISON, NJ - EIR, 483, WARNING LTR, CORR SINCE 2005
JM HUBER CORP - EIR, 483, WARNING LTR, CORR SINCE 2005
RE-LY (NCT 0262600), RELY-ABLE (NCT 00808060), TRIALS - EIRS, 483S, FDA FORM 1572
ERIN E. SEDER
PETER S. REICHERTZ
TRISH McGRADE
J SCOTT NABERS
SHERI O. COVINGTON
SHERI O. COVINGTON
JOHN CREWDSON
FOI SERVICES INC
VENABLE LLP
SHEPPARD MULLIN ET AL
PRITZKER OLSEN
BLIZZARD MCCARTHY & NABERS LLP
K&L GATES
K&L GATES
PROJECT ON GOVERNMENT OVERSIGHT
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/28/2013
01/29/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/26/2013
02/27/2013
2013-661
2013-662
2013-663
2013-664
2013-665
2013-666
2013-667
2013-668
FDA/OMPT/CDER/ORP/DIDP/
FDA/OO/OFBA/OAGS/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
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/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/
ORA/
ORA/OE/
ORA/OE/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/NE-FO/NWE-
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 5 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
PRADAXA (DABIGATRAN) - APRVL PKG, A/C, AGENDAS, ETC
BOEHRINGER INGELHEIM PHARMACEUTICALS - RELY-ABLE TRIAL RESULTS, RPTS 12/12
BOEHRINGER INGELHEIM PHARMACEUTICALS - RE-LY & RELY-ABLE TRIALS USER FEES; MERCK & CO INC - SHINGLES PREVENTION STUDY RVWS, USER FEES
HERPES ZOSTER VACCINE - VAERS 283902, 316387, 277377, ETC
AKRIMAX - TIROSINT 50 MG CMPLNT
VIGOR-25 - MFR NAMES, CONTACT RECS, DISTRIBUTORS NAMES, ETC
JOHN CREWDSON
JOHN CREWDSON
JOHN CREWDSON
JOHN CREWDSON
FRANCISCO JAVIER DAVALOS
PROJECT ON GOVERNMENT OVERSIGHT
PROJECT ON GOVERNMENT OVERSIGHT
PROJECT ON GOVERNMENT OVERSIGHT
PROJECT ON GOVERNMENT OVERSIGHT
DAVIS, DAWN
FARRIMOND CASTILLO & BRESNAHAN PC
01/29/2013
01/29/2013
01/29/2013
01/29/2013
01/29/2013
01/29/2013
02/27/2013
02/27/2013
02/27/2013
02/27/2013
02/27/2013
02/27/2013
2013-669
2013-670
2013-671
2013-672
2013-673
2013-674
DO/NWE-CB/
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-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/
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/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/
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/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 6 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
2011-7792, 2011-7791, 2011-7790, ETC
FOI DAILY LOG 1/03 TO PRESENT
PFIZER INC, (ZOETIS), KALAMAZOO, MI - 483S, WARNINGS 1/1-25/13
GATE GOURMET, BOSTON, MA, NEW YORK, NY, ELIZABETH, NJ, ETC - AIRPORT KITCHEN EIRS, VIOLATIONS, CMPLNTS RPTS, ETC
MARLENE LANTZ, MCHENRY COUNTY, IL, FDA CHICAGO FIELD OFFICE - MEMOS, MTG MINS, SUMMARIES, ETC 2005
CHRIS WEAVER
MOLLY SHEARER
DAVID B SUDZUS
WALL STREET JOURNAL
CAROLLO, RUSSELL
SCHONHOFT, BRAD
UNITEHERE!
01/29/2013
01/29/2013
01/29/2013
01/29/2013
01/29/2013
02/27/2013
02/27/2013
02/27/2013
02/27/2013
2013-675
2013-676
2013-677
2013-678
2013-679
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-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/KAN-DO/KAN-CB/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 7 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
7345315, 7389965, 7419534 ETC - FAERS DETAILED RPTS
MILO'S KITCHEN CHICKEN JERKY RECALL - INSPECTIONS, TESTING, RECALL RECS, ETC
INTERNAL CORR RE CLINICAL TRIAL COMPLAINT
FACTS ASSIGNMENT 808885 - TRAVEL VOUCHERS, RECEIPTS, EXPENSES, ETC
PROTOCOL, BACKGROUND INFORMATION SENT TO DISTRICT OFFICE FOR FACTS ASSIGNNMENT 808885
CFSAN FOIA REQUESTS (01/04/2013 - 01/28/2013)
INDIVIDUAL RECS
INDIVIDUAL RECS
CORR RE CSO AND SUPERVISOR FOR FACTS ASSIGNMENT 808885
Gary Wolff
Ryan T. Kearney
B Burges
b. Burges
b burges
Megan Pickel
b. burgess
DRINKER BIDDLE REATH LLP
SHIRE PHARMACEUTICALS INC
COZEN O'CONNOR
BURGESS, BERNIE
BURGESS, BERNIE
BURGESS, BERNIE
Beveridge & Diamond, PC
Doe J
Doe J
BURGESS, BERNIE
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/27/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-680
2013-681
2013-682
2013-683
2013-684
2013-685
2013-686
2013-687
2013-688
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
CVM/OCD/
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OC/COS/OES/
OC/COS/OES/
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/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OF/CFSAN/OCD/EOS/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/OCI/
ORA/OCI/
FDA/OO/OHR/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 8 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
HILL-ROM, INC, BATESVILLE, IN - INSPECTION RECS (03/01/2011 - 1/28/13)
RANBAXY ATORVASTATIN - AERS (11/01/2012 - 01/28/2013)
FOIA REQUEST LOG (01/21/2013 - 01/25/2013)
NUVARING, YAZ, YASMIN - AERS (01/01/2009 - 01/28/2013)
NUTRO PET FOOD - LAB RESULTS SINCE JAN 2012
SCULTPRA - PACKAGE AND PRODUCT INSERTS (01/01/2009 - 01/28/2013)
AETERNA ZENTARIS INC, KERYX BIOPHARMACEUTICALS - PHASE 2 AND PHASE 3 TRIALS TESTING PERIFOSINE FOR TREATMENT OF COLORECTAL CANCER
VACCINE LOT NUMBERS R05172, 471804, 469395
K112946
OSTEOCEL, TRINITY - AERS
Alexander Barney
Jeff Overley
Johnathan Rickman
Lynn Walsh
David Hanson
Courtney Burgess
Richard Gonnello
Anne-Solenne Rolland
Bob Bowers
Jim Petricek
The Karmel Law Firm
Law360
FDANEWS
WPTV 5
N/A
Sugarman & Sugarman, P.C.
Faruqi & Faruqi, LLP
Sutton Law Group, P.A.
OBT
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-689
2013-690
2013-691
2013-692
2013-693
2013-694
2013-695
2013-696
2013-697
2013-698
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
ORA/
ORA/
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/
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/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 9 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
INDIVIDUAL RECS
GUIDE TO INFORMED CONSENT - INFORMATION SHEET 2004
PREDNISONE - AERS (01/01/2012 - 01/28/2013)
FCN 725
IND 104117 - CORR
K113188
K090995
K112994
IND 104861 - CORR
K854334
ANDA 74531 S1
Kathryn del Real
Christopher Lotito
Rachel Johnson
Kevin Sill
Rachel Johnson
Rachel Johnson
Laura Boll
Kevin Sill
Rachel Johnson
Rachel Johnson
Harpeth Advisors
Doe J
The Cavanagh Law Firm
Biotechnology Dashboard
FOI SERVICES INC
Intezyne
FOI SERVICES INC
FOI SERVICES INC
Medovations Inc.
Intezyne
FOI SERVICES INC
FOI SERVICES INC
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-699
2013-700
2013-701
2013-702
2013-703
2013-704
2013-705
2013-706
2013-707
2013-708
2013-709
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OO/OHR/
OM/OMP/DODM/
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/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/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/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 10 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
ANDA 091328
K922187
QUETIAPINE - AERS
IMS TRADING CORP - INSPECTIONS, INVESTIGATIONS, RECALLS ETC
WAGGIN TRAIN, CANYON CREEK - INSPECTIONS, INVESTIGATIONS, RECALLS ETC
CADET CHICKEN JERKY PET TREATS - INSPECTION, INVESTIGATION, TESTING ETC
VASCEPA (ICOSAPENT ETHYL) - PHARMACODYNAMIC & PHARMACOKINETIC DATA, PHASE 1 & PHASE 2 TESTING, ETC
ALLEGIANCE HEALTHCARE CORP - EXCHANGE TRANSFUSION TRAY PROCEDURE TRAY FDA FORM 3500A, RPTS, MEMOS, ETC
ALOE VERA - REGULATORY STATUS, CONSUMPTION, SAFETY RECS, ETC
Rachel Johnson
Jeff Wurtsbaugh
Krista Brown (Pharmacist)
Ryan T. Kearney
Ryan T. Kearney
Ryan T. Kearney
ROSS D PLONT
CLAUDIA NUNN
FOI SERVICES INC
PromoLogics, Inc.
Krista Brown (pharmacist, BRHA)
COZEN O'CONNOR
COZEN O'CONNOR
COZEN O'CONNOR
BORON, MELANIE
GRUEL MILLS NIMS & PYLMAN LLP
BURDOCK GROUP
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-710
2013-711
2013-712
2013-713
2013-714
2013-715
2013-716
2013-717
2013-718
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/
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/NYK-DO/NYK-DCB/
CVM/OCD/
CVM/OCD/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
CVM/OCD/
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OF/CFSAN/OCD/EOS/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 11 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
HILL-ROMM, BATESVILLE, IN - 483S 10/12, 11/12
DENOSUMAB BLA 125320 - APRVL RECS
AKORN INC, DECATUR, IL 5/14-25/12; ABBOTT MOLECULAR, DES PLAINES, IL 7/2-11/12; BIOSYNERGY INC, ELK GROVE VILLAGE, IL 2/27/12-3/2/12, ETC - 483S
PAIN MANAGEMENT TECHNOLOGIES INC, AKRON, OH 6/4-8/12; CASCO MANUFACTURING SOLUTIONS INC, CINCINNATI, OH 5/7-10/12; REESE PHARMACEUTICAL CO, CLEVELAND, OH 12/14/11-1/11/12, ETC - 483S
KIMBERLY CLARK CORP, CONWAY, AR 4/23-27/12; ENCOMPASS GROUP LLC, ADDISON, TX 1/18-20/12; MISSION PHARMACAL CO, BOERNE, TX 5/9-25/12. ETC - 483S
ACELLA PHARMACEUTICALS LLC, ALPHARETTA, GA 3/19-22/12; REMINGTON MEDICAL INC, ALPHARETTA, GA 5/21/12-6/6/12; BANNER PHARMACAPS INC, HIGH POINT, NC 6/25/12-7/2/12, ETC - 483S
PETNET SOLUTIONS INC - EIRS, 483S, CO RESP 2/12
BECTON DICKINSON MEDICAL SYSTEMS, CANAAN, CT 3/14-16/12; PFIZER INC, GROTON, CT 2/21-24/12; Z-MEDICA CORP, WALLINGFORD, CT 3/29/12-4/11/12, ETC - 483S
ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY 3/15-19/12; AMNEAL PAHRMACEUTICALS OF NEW YORK LLC, HAUPPAUGE, NY 5/8-15/12; FOREST LABORATORIES INC, COMMACK, NY 2/15-22/12, ETC - 483S
CIANNA MEDICAL INC, ALISO VIEJO, CA 12/14/11-1/9/12; REVITOL CORP, BURBANK, CA 4/24/12-6/1/12; PURQUALITY LLC, TEMPE, AZ 1/10-30/12, ETC - 483S
PHARMATEC LLC, DAVIE, FL 1/12-24/12; BECKMAN COULTER INC, HIALEAH, FL 7/16-20/12; PACE TECH INC, CLEARWATER, FL 3/15-19/12, ETC - 483S
2012-7518
TRAVIS SCHAFTENAAR
JOSEPH M LANE MD
WALTER E CHALKLEY
WALTER E CHALKLEY
UBS GLOBAL ASSET MANAGEMENT
HOSPITAL FOR SPECIAL SURGERY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMSON REUTERS
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMSON REUTERS
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-719
2013-720
2013-721
2013-722
2013-723
2013-724
2013-725
2013-726
2013-727
2013-728
2013-729
2013-730
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-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/SE-FO/FLA-DO/FLA-CB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 12 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
ST MARY'S HOSPITAL & MEDICAL CENTER INC, GRAND JUNCTION, CO - EIRS, 483S, CO RESP 6/4-15/12
TAIWAN THREE MAST PHARMACEUTICAL CO LTD, TAINAN CITY, TAIWAN - EIRS, 483S, CO RESP 4/23-27/12
APHENA PHARMA SOLUTIONS-MARYLAND LLC, EASTON, MD 1/9-13/12; MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV 1/23/12-2/2/12; BOEHRINGER INGELHEIM CHEMICALS INC, PETERSBURG, VA 3/22/12-4/4/12 - 483S
RUGER CHEMICAL, LINDEN, NJ - EIRS, 483S, CO RESP 9/22/11-10/11/11
AMGEN INC, BOULDER, CO 12/14/11-1/6/12; ADAPTA MEDICAL INC, COLORADO SPRINGS, CO 1/23-26/12; NELSON LABORATORIES INC, SALT LAKE CITY, UT 3/5-9/12, ETC - 483S
GLOBUS MEDICAL INC, AUDUBON, PA 4/18/12-5/1/12; AUXILIUM PHARMACEUTICALS INC, HORSHAM, PA 6/25/12-7/6/12; MUTUAL PHARMACEUTICAL CO INC 1/9-27/12, ETC - 483S
SAGE PHARMACEUTICALS INC, SHREVEPORT, LA 2/14-17/12; HAWTHORN PHARMACEUTICALS INC, MADISON, MS 1/30/12-2/15/12; ONYX MEDICAL CORP, LMEMPHIS, TN 2/1-13/12, ETC - 483S
MIRGEN PHARMACEUTICAL, BOISE, ID 1/9-30/12; GENETECH INC, HILLSBORO, OR 6/19-27/12; GYNEX CORP, REDMOND, WA 7/16-20/12, ETC - 483S
HUMAN DRUG, MEDICAL DVC FIRMS - GMP, GLP, GCP INSPS 8/1/12-12/31/12
HERBRAND PHARMACHEMICALS GMBH, GENGENBACH, GERMANY 6/11-15/12; SCICAN BHT, GERSTHOFEN, GERMANY 7/16-19/12; BASF PHARMACHEMIKALIEN GMBH &CO KG, MINDEN GERMANY 2/6-10/12,ETC - 483S
JHP PHARMACEUTICALS LLC, ROCHESTER, MI - EIR, 483, CO RESP 3/12
GUARDIAN DRUG CO, DAYTON, NJ - EIR, 483, CO RESP 3/12
WALTER E CHALKLEY
WALTER E CHALKLEY
WALTER E CHALKLEY
WALTER E CHALKLEY
WALTER E CHALKLEY
THOMSON REUTERS
THOMSON REUTERS
THOMPSON, RAY
THOMSON REUTERS
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMSON REUTERS
THOMSON REUTERS
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-731
2013-732
2013-733
2013-734
2013-735
2013-736
2013-737
2013-738
2013-739
2013-740
2013-741
2013-742
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
ORA/ORM/
ORA/ORM/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 13 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
NOVO NORDISK A/S, GENTOFTE, DENMARK 6/28-26/12; NOVO NORDISK A/S, HILLEROED, DENMARK 3/21/12; NOVO NORDISK A/S, KALUNDBORG, DENMARK 3/5-9/12 - 483S
RTI BIOLOGICS, ALACHUA, FL - EIR, CORR 6.25/12-7/11/12
GENZYME FLANDERS NV, GEEL, BELIGIUM 1/16/24/12; HOSPIRA COSTA RICA LTD, LA AURORA DE HEREDIA, COSTA RICA 4/16-19/12; BRISTOL-MYERS SQUIBB, ANAGNI,ITALY 3/5-8/12, ETC - 483S
BECTON DICKINSON DE MEXICO, CUAUTITLAN IZCALLI, MEXICO 1/16-19/12; AKZO NOBEL CHEMICALS SA DE CV, LOS REYES LA PAZ EDO, MEXICO 3/26-30/12 - 483S
SHIONGI & CO LTD, AMAGASAKI-SHI, JAPAN 2/10-15/12; TAKEDA PHARMACEUTICAL CO LTD, HIKARI, JAPAN 7/17-20/12 - 483S
DEPUY (IRELAND) LOUGHBEG, RINGASKIDDY, IRELAND 1/23-26/12; JANSSEN BIOLOGICS (IRELAND) BARNAHELY, RINGASKIDDY, IRELAND 6/12-18/12 - 483S
DR MALCOLM PAUL, NEWPORT BEACH, CA 6/14/12-7/17/12; DR RICHARD D'AMICO, ENGLEWOOD, NJ 10/11/12-11/12/12, ETC - EIR, 483, CO RESP
ASTRAZENCA, MACCLESFIELD, CHESHIRE, UK 3/12-16/12; DEPUY INTERNATIONAL LTD, LEEDS, UK 2/13-16/12 - 483S
WALTER E CHALKLEY
WALTER E CHALKLEY
THOMPSON, RAY
THOMSON REUTERS
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMSON REUTERS
THOMPSON, RAY
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-743
2013-744
2013-745
2013-746
2013-747
2013-748
2013-749
2013-750
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
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/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-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/OMPT/CDRH/OCER/DFOI/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 14 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
HAMELN PHARMACEUTICALS GMBH, HAMELN, GERMANY -EIR, 483, CO RESP 6/4-14/12
NOVARTIS PHARMA BPO, HUNINGUE, FRANCE 1/23-31/12; SANOFI CHIMIE, PLOERMEL, FRANCE 3/26-30/12 - 483S
APP PHARMS, GRAND ISLAND, NY - EIR, 483, CORR 10/2-19/12
BOEHRINGER INGELHEIM RCV GMBH, VIENNA, AUSTRIA 3/15/23/12; DSM FINE CHEMICALS AUSTRIA GMBH NFG GMBH & CO KG, LLINZ, AUSTRIA 5/29-12-6/1/12 - 483S
POLYMED THERAPEUTICALS INC, ERLANG, CHINA 5/21-23/12; CHONGQING KANGLE PHARMACEUTICAL CO LTD, CHONGQING, CHINA 4/23-26/12 - 483S
ABBOTT BIOTECHNOLOGY LTD, BARCELONETA, PR 6/26/12-7/12/12; BIO LAB-ST JOSEPH CORP, BAYAMON, PR 4/17/12-5/9/12; ABBOTT DIAGNOSTICS INTERNATIONAL LTD, BARCELONETA, PR 1/18-12-3/12/12, ETC - 483S
IMPLANT RESCOURCE INC, BURNSVILLE, MN 5/16-12-6/17/12; MEDTRONIC NEUROMODULATION, MINNEAPOLIS, MN 3/14/12-5/9/12; BOSTON SCIENTIFIC CRM CORP, SAINT PAUL, MN 3/19/12-4/16/12, ETC
GLAXOSMITHKLINE CONSUMER HEALTHCARE LP, CLIFTON, NJ 12/20/11 TO 1/9/12; AUSTARPHARMA LLC, EDISON, NJ 5/30/12-6/5/12; ACTAVIS ELIZABETH LLC, ELIZABETH, NJ 12/13/11 TO 1/13/12, ETC - 483S
NOVARTIS VACCINE & DIAGNOSTICS INC, EMERYVILLE, CA 3/20-30/12; IMMUNETECH INC, FOSTER CITY, CA 3/12-23/12; BIOGENEX LABORATORIES INC, FREMONT, CA 12/20/11 TO 1/6/12, ETC - 483S
SANDOZ PRIVATE LTD (NOVARTIS), NAVI MUMBIA, INDIA
WALTER E CHALKLEY
WALTER E CHALKLEY
THOMSON REUTERS
THOMPSON, RAY
THOMSON REUTERS
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
2013-751
2013-752
2013-753
2013-754
2013-755
2013-756
2013-757
2013-758
2013-759
2013-760
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/
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/NYK-DO/NYK-DCB/
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/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OMPT/CDER/ORP/DIDP/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 15 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
1/2-9/12; CADILA HEALTHCARE LTD, AHEMEDABAD CITY, INDIA 2/13-23/12; CIPLALTD, BANGALORE, KARNATAKA, INDIA 6/21-28/12, ETC - 483S
NOVARTIS PHARMA AG, BASEL, SWITZERLAND 7/19-26/12; CILAG AG, SCHAFFHAUSEN, SWITZERLAND 4/20-27/12; NOVARTIS PHARMA STEIN AG, STEIN, SWITZERLAND 6/11-22/12, ETC - 483S
APOTEX FERMENTATION INC, WINNIPEG, CANADA 6/4-7/12;CONTRACT PHARMACEUTICALS LTD (CPL), MARKHAM, CANADA 1/31/12 TO 2/2/12; CARDIOMED SUPPLIES INC, LINDSAY, CANADA 2/20-23/12 - 483S
FCN 1206
PETNET SOLUTIONS, KENT, WA - EIR 2/12
BACHEM INC, TORRANCE, CA - EIR 1/20/12
PETNET SOLUTIONS, ST LOUIS, MO - EIR 2/11
2008-1744, 2011-7185, 2012-3210, ETC
2008-3812, 2012-3360, 2012-3741
RECS RE: FOI REQUEST
ADVANCED ORTHOPRO INC, INDIANAPOLIS, IN 4/6-26/12; L PERRIGO CO, ALLEGAN, MI 4/17/12-5/8/12; ACUMEDIA MANUFACTURERS INC, LANSING, MI 12/19/11-1/9/12, ETC - 483S
K062604
OSCAR GOODMAN, NEVADA CANCER CENTER, LAS VEGAS, NV - EIR (6/25/2012 - 07/03/2012)
CYNTHIA B LIEBERMAN
BRENDA M GARTZ
BRENDA M GARTZ
BRENDA M GARTZ
CHRISTOPHER WEAVER
CHRISTOPHER WEAVER
BERNIE BURGESS
Richard Superfine
Rachel Johnson
THOMPSON, RAY
THOMPSON, RAY
THOMPSON, RAY
Keller and Heckman LLP
ELI LILLY & CO
ELI LILLY & CO
ELI LILLY & CO
WALL STREET JOURNAL
WALL STREET JOURNAL
BURGESS, BERNIE
THOMPSON, RAY
Rheomics, Inc.
FOI SERVICES INC
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/30/2013
01/31/2013
01/31/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
02/28/2013
03/01/2013
03/01/2013
2013-761
2013-762
2013-763
2013-764
2013-765
2013-766
2013-767
2013-768
2013-769
2013-770
2013-771
2013-772
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/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 16 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
MEDIVATION, SAN FRANCISCO, CA - EIR 06/08/12
INVACARE - INSPECTION RECS, CORR, UNTITLED LETTER ETC
GENENTECH, HILLSBORO, OR; GENENTECH, SAN FRANCISCO; GENENTECH, VACAVILLE, CA ETC - 483
AIDI BIOMEDICAL - MDR SINCE 01/01/2013
SYNOVIS DURA-GUARD - SAMPLE RESULTS
ANDREW ARMSTRONG, DUKE UNIVERSITY MEDICAL CENTER, DURHAM, NC - EIR (6/13/12)
ETHICON, ETHICON ENDO-SURGERY GASTRIC BYPASS SURGERY STAPLERS - COMPLAINTS, INVESTIGATIONS, REPORTS ETC
NDA 203491
HSH-QEC-12-D-00002
RILUZOLE - SUMMARIES OF IN VITRO AND ANIMAL SAFETYPHARMACOLOGY AND TOXICOLOGY STUDIES
FAP 2269
AGA MEDICAL CORP - MATERIALS SUBMITTED FOR OCCLUDER OR OCCLUSION DEVICE (01/02/1996 - 01/02/2001)
Rachel Johnson
Michael Feiler
Linda Bowen
Juan Herrera
Joshua A. Leach
Rachel Johnson
Laura Hass
Mahidhar Chinta
Shadonna Messiah
Jay Wrobel, Ph.D.
Scott Krygier
Tomas Friend
FOI SERVICES INC
Qulling Selander Lownds Winslett &Moser
SANOFI
AIDI Biomedical
Baxter Healthcare Corp.
FOI SERVICES INC
Hass, Laura
MICRO LABS USA INC
United Union Of Security Guards
Fox Chase Chemical Diversity Center
BASF - The Chemical Company
KIPA AB
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
2013-773
2013-774
2013-775
2013-776
2013-777
2013-778
2013-779
2013-780
2013-781
2013-782
2013-783
2013-784
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OMPT/CDRH/OCER/DFOI/
ORA/
ORA/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-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/OO/OFBA/OAGS/
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/CDRH/OCER/DFOI/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 17 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
HILL-ROM, BATESVILLE, IN - 483 (09/01/2012 - 01/01/2013)
US PHARMA LAB INC, NORTH BRUNSWICK, NJ - EIR (01/01/2012 - 01/01/2013)
PMA P000039
K014018
RSA CORP, DANBURY, CT; ALLERQUEST LLC, PLAINVILLE, CT; PCI SYNTHESIS, NEWBURYPORT, MA, ETC - 483S 12/1-31/12
GUY & O'NEILL INC, FREDONIA, WI; BRUNO INDEPENDENT LIVING AIDS INC, OCONOMOWOC, WI - 483S 12/1-31/12
CUSTOM COMPOUNDING CENTERS, LOS ALAMITOS, CA; SCIENTIFIC PHARMACEUTICALS INC, POMONA, CA; BIOSEAL CORP. PLACENTIA, CA, ETC - 483S 12/1-31/12
NESHER PHARMACEUTICALS (USA) LLC, BRIDGETON, MO; NESHER PHARMACEUTICALS (USA), LLC, SAINT LOUIS, MO;WEXFORD LABS INC, KIRKWOOD, MO - 483S 12/1-31/12
ORION CORP, ESPOO, FINLAND - 483S 12/1-31/12
AMERICAN ORTHO-TECH (P) LTD, CHENNAI, TAMBRAM, INDIA; UNOMEDICAL LSDN BHD, SUNGAI PETANI, KEDAH, MALAYSIA; GARAVENTA (CANADA) LTD, ST SURREY, CANADA, ETC - 483S 12/1-31/12
BSP PHARMACEUTICALS SRL, LATINA SCALO, ITALY; FARMHISPANIA SA, MONTMELO, SPAIN; SICOR SRL, SANTHIA (VC), ITALY, ETC - 483S 12/1-31/12
PETNET SOLUTIONS INC, FORT LAUDERDALE, FL; CFS DENTAL INC, HIALEAH, FL; VYCOR MEDICAL INC, BOCA RATON, FL, ETC - 483S 12/1-31/12
Xiang Liu
LIFE EXTENSION - Alexandra Ajmo
Tomas Friend
Cathy Shachaf
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
Blackrock
Ajmo, Alexandra
KIPA AB
Orlucent
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
2013-785
2013-786
2013-787
2013-788
2013-789
2013-790
2013-791
2013-792
2013-793
2013-794
2013-795
2013-796
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
ORA/
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/
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/FLA-DO/FLA-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 18 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
PFIZER INC, ROCHESTER, MI; EXCEL MEDICAL PRODUCTS INC, FENTON, MI - 483S 12/1-31/12
BENCHMARK MEDICAL INC, SALT LAKE CITY, UT; WATSON LABORATORIES INC, SALT LKE CITY, UT; FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN, UT, ETC
AMERICAN PHARMACEUTICALS & COSMETICS INC, FORT WORTH, TX; CYBERONICS INC, HOUSTON, TX; MEDRO SYSTEMS INC, MCKINNEY, TX, ETC - 483S 12/1-31/12
PEMCO INC, INDEPENDENCE, OH; NORMAN NOBLE INC, HIGHLAND HEIGHTS, OH; HAVELS INC, CINCINATI, OH, ETC - 483S 12/1-31/12
MEDFIL INC, GLENDALE HEIGHTS, IL; LATTICE INC, WHEATION, IL; DEL MEDICAL INC, ROSELE, IL - 483S 12/1-31/12
RX SOUTH LLC (DBA RX3 PHARMACY), CHESTER, VA; HEMAGEN DIAGNOSTICICS INC, COLUMBIA, MD; ACELL INC, COLUMBIA, MD - 483S 12/1-31/12 - 483S 12/1-31/12
SUMMIT INDUSTRIES, MARRIETA, GA; HEAVENLY HARVESTINC, MOULTRIE, GA - 483S 12/1-31/12
BLOOD BANK COMPUTER SYSTEMS INC, AUBURN, WA; CARDINAL LHEAL 414 INC, SEATTLE, WA; MALONEY'S CUSTOM OCULAR PROSTHETICS, LAKE OSWEGO, OR, ETC- 483S 12/1-31/12
SALIX PHARMACEUTICALS - RELISTOR (METHYLNALTREXONE BROMIDE) CO RESP
INDIVIDUAL RECS
LTR TO KAREN TANNERT, RPH TX DEPT OF STATE HEALTHSERVICES 5/4/05
NU WORLD CORP, CARTERET, NJ; OHM LABORATORIES INC, NEW BRUNSWICK, NJ; CATALENT PHARMA SOLUTIONS LLC, SOMERSET, NJ - 483 12/12
BD CARIBE LTD, CAYEY, PR; KNOLL LLC, JAYUYA, PR - 483 12/12
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHANTHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
LEO STERNLICHT
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
RIDGEBACK CAPITAL MANAGEMENT LLC
MASSEY, GEORGE
KYRIAKIDIS, JOANNA
FDA NEWS
FDA NEWS
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
2013-797
2013-798
2013-799
2013-800
2013-801
2013-802
2013-803
2013-804
2013-805
2013-806
2013-807
2013-808
2013-809
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-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/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 19 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
INTERSECT ENT INC, PALO ALTO, CA; AMPAC FINE CHEMICALS LLC, RANCHO CORDOVA, CA; NATUREX INC, SHINGLE SPRINGS, CA - 483 12/12
B BRAUN MEDICAL INC, ALLENTOWN, PA - 483 12/12
ASCENT PHARMACEUTICALS INC, CENTRAL ISLIP, NY; HI TECH PHARMACAL CO INC, AMITYVILLE, NY; NOVARTIS PHARMACEUTICALS CORP, SUFFERN, NY - 483 12/12
CRYOSURGERY INC, NASHVILLE, TN; AXIS HEALTH CARE LLC, MONTGOMERY, AL - 483 12/12
CANNULATED BONE SCREW K061620; BONE FIXATION DEVICE K071035; PROFILE PLATES SCREWS & WASHERS K110086
AN DERINGER INC - LTR SHOWING CO AS AN AGENT OF THE US
ACIST ANGIOGRAPHIC CONTRAST MGMT INJECTORSYS MODEL CMS2000 k991103; ACIST ANGOGRAPHIC INJECTION SYS, MODEL R2000 CMS (K010390); ACIST ANGIOGRAPHIC CONTRAST MGMT SYS (K984231)
CARDINAL HEALTH EXCHANGE TRANSFUSION TRAY 6/13/07
ALLEGIANCE HEALTHCARE PHARMASEAL EXCHANGE TRANSFUSION TRAY 2/20/02
RESPONSE LTR FROM FDA TO CETERO RESEARCH 7/26/11
INDIVIDUAL RECS
HARTZ CHICKEN CHEWS, HARTZ OINKIE PIG SKIN WRAPPED WITH CHICKEN - INVESTIGATION, INSPECTIONS, TESTING, ETC
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
JOHNATHAN RICKMAN
CHRISTOPHER B. SPUCHES, Esq.
ROBERT A. DeCAMP
SARA BEARDSLEY
ROSS D. PLONT
ROSS D. PLONT
MARK SCHOOFS
Ryan T. Kearney
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
EHRENSTEIN CHARBONNEAU ET AL
DERINGER LOGISTICS CONSULTING GROUP
SIDLEY AUSTIN LLP
GRUEL MILLS NIMS & PYLMAN LLP
GRUEL MILLS NIMS & PYLMAN LLP
PRO PUBLICA
COLOSI, JOSEPH A
COZEN O'CONNOR
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
01/31/2013
02/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/01/2013
03/04/2013
2013-810
2013-811
2013-812
2013-813
2013-814
2013-815
2013-816
2013-817
2013-818
2013-819
2013-820
2013-821
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDRH/OCER/DFOI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
ORA/OCI/
ORA/OCI/
CVM/OCD/
FDA/OGROP/ORA/CE-FO/NWJ-
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 20 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
FORTEO - NUMBER OF MEDWATCH RPTS FOR OSTEOSARCOMA, BONE CANCER
KARIM FIZAZI, INSTITUTE GUSTAVE-ROUSSY, VILLEJUIF, FRANCE - EIR (07/30/2012 - 08/03/2012)
WOLFGANG LOIDL, LINZ UROLOGIE ABTEILUNG, LINS, AUSTRIA - EIR (08/2012)
SAMPLE 661933 - ALL RECS
SUREPATH FLUID COLLECTION VIAL - FOI REQUESTS
DKT 2008P-0347
PHARMEDIUM SERVICES LLC - WARNING LTRS, APRVL RECS, INSPS, ETC 1/07 TO PRESENT
CENTRAL ADMIXTURE PHARMACY SERVICES INC, B BRAUN MEDICAL INC - WARNING LTRS, APRVL RECS, INSPS, ETC 1/07 TO PRESENT
Bobbie Sanderson
Rachel Johnson
Rachel Johnson
Becky Cooseman
CHARLOTTE VALLAEYS
REBECCA FIELD EMERSON
REBECCA FIELD EMERSON
Sanderson, Bobbie
FOI SERVICES INC
FOI SERVICES INC
Brown & Crouppen, PC
MINTZ GROUP
CORNUCOPIA INSTITUTE
MITTS LAW LLC
MITTS LAW LLC
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
2013-822
2013-823
2013-824
2013-825
2013-826
2013-827
2013-828
2013-829
DO/NWJ-CB/
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/
ORA/
ORA/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
FDA/OF/CFSAN/OCD/EOS/
OC/COS/OES/
OC/COS/OES/
OM/OMP/DODM/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
ORA/
ORA/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
ORA/
ORA/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 21 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
JANSSEN PHARMA - TERAZOL 3 (TERCONAZOLE) VAGINALSUPPOSITORY NDA 19-641; PERRIGO NEW YORK - TERCONAZOLE VAGINAL SUPPOSITORY ANDA 77-149 SBA
NAMES OF ESTABLISHMENTS ENGAGED IN THE MANUFACTURE, PREPARATION, COMPOUNDING OF TOBACCO PRODS
HAIR STRAIGHTENER COSMETICS - CAERS 2000 TO PRESENT
OCTAPHARMA AB, STOCKHOLM, SWEDEN - 483 1/11
DKT 2012P-0566
CONKLIN COMPANY INC - EIR, 483, CO RESP 10/12
INDIVIDUAL RECS
AAI PHARMA SERVICES, EDISON, NJ - EIR 3/15/12; IRVINE PHARM SERVICES, IRVINE, CA - EIR 11/24/09, 4/2/12; NORTH AMERICAN SCIENCE ASSOC INC, IRVINE, CA - EIR 10/14/11; NORTH AMERICAN SCIENCE ASSOC, NORTHWOOD, OH - EIR 12/9/11
DKT FDA-1975-N-0355
RAVI DESHPANDE
DAVID C STEINBERG
WALTER E CHALKLEY
Lorraine Shelton
GLORIA GASKINS
ACINO PRODUCTS LLC
FOI SERVICES INC
STEINBERG & ASSOCIATES INC
CURTIN, DENNIS D
Empire State Consumer Project, Inc
THOMSON REUTERS
Doe J
Exova Inc.
KLEINFELD, KAPLAN & BECKER
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
02/01/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
03/04/2013
2013-830
2013-831
2013-832
2013-833
2013-834
2013-835
2013-836
2013-837
2013-838
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CTP/OD/
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/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/
OM/OMP/DODM/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
OC/OM/OMP/DDM/
Thursday February 7 2013 11:43 AM
Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report
Total Records: 212
Page 22 of 22
Control # Recd Date /Due Date
Action Office Signature/ Requester Subject
OTC VOLS. 160414, 160397ANGELIA SLAYTON
INC RESEARCH
02/01/2013
03/04/2013
2013-839 OC/OM/OMP/DDM/