query result report - fdanews · 510k redacted and released in august 2013 not sent to foi services...
TRANSCRIPT
Query Result ReportRecords: 336
Rec/Create Date:
Due Date:
Status Date:
Action Office: ALL
09/09/2013 09/13/2013To
To
To
Requester:
Control #:
Track: ALL
Signature:
Status: ALL
Privacy:
Subject:
Received Via: BOTH
Requester Type:
Category: ALL
Entered By:Special Interest: ALL
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 2 of 46
2013-7088
2013-7089
2013-7090
2013-7091
2013-7092
2013-7093
2013-7094
2013-7095
2013-7096
2013-7097
2013-7098
2013-7099
2013-7100
2013-7101
2013-7102
2013-7103
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
NDA 22047 S 11
AGRI-MECTIN PLUS CLORSULON - FOIASUMMARY
TECTUBES USA, VINELAND, NJ - EIR, 483, RECALL
510K REDACTED AND RELEASED IN AUGUST 2013 NOT SENT TO FOI SERVICES
STERIGENICS, WILLOWBROOK, IL - EIR, 483, RECALL
REMEL, INC, LENEXA, KS - 483, RESPONSE 01/01/2010 - 09/03/2013
INHANCE TECHNOLOGIES, ALLENTOWN,PA - EIR, 483, RECALL 06/01/2011 - 09/03/2013
K052925, K991430
ANDA 077425
K111391, K111375, K111377
ST JUDE MEDICAL - EIR 6/8/2009 TO 7/8/2009, ATTACHMENT 5
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE MEETINGS RE MDR-TB - MINUTES 06/01/2009 - 11/29/2012
INDIVIDUAL RECS
SANQUIN PLASMA PRODUCTS, AMSTERDAM, NETHERLANDS - 483, EIR 05/15/2013 - 09/04/2013
4MEI IN SOFT DRINKS - FOIA REQUESTS
4MEI IN SOFT DRINKS AND CARAMEL COLOR - CORR
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/10/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Partial Response
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Due Date
FOI Services, Inc.
Merial Limited
James Alexander Corporation
FOI Services, Inc.
James Alexander Corporation
Fresenius Kabi USA, LLC
James Alexander Corporation
J Brown Enterprises
Anna Azvolinsky
ADVANCED STERILIZATION PRODUCTS
Kessler Topaz Meltzer Check LLP
BLOOMBERG NEWS
Elizabeth Johnson
Kingdon Capital Management
FOI Services, Inc.
FOI Services, Inc.
FDA/OMPT/CDER/ORP/DIDP/
CVM/OCD/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OC/OES/DDM/
ORA/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
CVM/OCD/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OC/OES/DFOI/
FDA/OF/CFSAN/OCD/EOS/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 3 of 46
2013-7104
2013-7105
2013-7106
2013-7107
2013-7108
2013-7109
2013-7110
2013-7111
2013-7112
2013-7113
2013-7114
2013-7115
2013-7116
2013-7117
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
42 FR 14308
Entry # 523-1008810-0 ANALYTICAL WORKSHEETS
PERIPHERAL AND CNS DRUGS ADVISORY COMMITTEE MEETINGS - AGENDAS, ROSTERS, MINUTES ETC 01/01/1989 - 01/01/1999
K070761;
FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection - AERS REPORTING
FORM 483 FOR QUALITY AND STERILITYTESTING LABORATORIES RE COMPOUNDING PHARMACIES 01/01/2013 - 09/04/2013
35 FR 18623 Dec. 12, 1970; 36 FR 12093 June 25, 1971; 37 FR 25705 Dec. 2, 1972 ETC
MEDTRONIC MINIMED PARADIGM INSULIN INFUSION SET - RECALL RECS
JUBILANT-HOLLISTERSTIER, SPOKANE, WA - EIR, 483, WARNING LETTER 09/01/2005 - 09/01/2013
COMPLAINTS MADE TO DSI RE CLINCAL TRIAL RECRUITMENT OR CLINICAL TRIAL MARKETING
SCOPOLAMINE - MEDWATCH FORMS; PADER; PSUR
METOCLOPRAMIDE - SRS SPONTANEOUS REPORTING SYSTEM SUMMARY DATA
GRANDFATHERED TOBACCO PRODUCTS
INDIVIDUAL RECS
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
09/11/2013
09/09/2013
09/17/2013
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Closed
Pending Action
Closed
Due Date
Alberto Soler
LALILAB, INC.
Lon Schneider MD
GPC Medical Limited
Heywood Hospital
THE PINK SHEET
Alberto Soler
Ashcraft& Gerel
BAYER HEALTHCARE
Walker, Joseph
MELLINO ROBENALT LLC
Center for the Study of Empathic Therapy
FOI Services, Inc.
Hudson Highlands Veterinary Medical Group
FDA/OC/OES/DDM/
ORA/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OC/OES/DDM/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
ORA/
FDA/OC/OES/DDM/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OMPT/CDRH/OCER/DFOI/
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/
CVM/OCD/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 4 of 46
2013-7118
2013-7119
2013-7120
2013-7121
2013-7122
2013-7123
2013-7124
2013-7125
2013-7126
2013-7127
2013-7128
2013-7129
2013-7130
2013-7131
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
ALPRAZOLAM - AERS, STUDIES
DATA OF TECHNOLOGICAL CHARACTERISTICS AND BIOMECHANIALTESTING/BENCH TESTING OF PREDICATE DEVICES
YASMIN - AERS
YAZ - AERS
LIDODERM PATCH - AERS
ALL ADVERSE EVENTS REPORTED TO THE FDA BY DEPARTMENT OF DEFENSEEMPLOYEES, TO INCLUDE TRICARE EMPLOYEES, MILITARY DOCTORS, MILITARY PHARMACISTS, AND ANY OTHER DEPARTMENT OF DEFENSE EMPLOYEE FOR THE DRUG MEFLOQUINE
K090450
K090850, K082575, K081979 ETC
NICOSIN EXTRUSION, BRAZIL, IN - EIR, 483, RECALL 09/05/2010 - 09/05/2013
FAP 5A4459, 5A4460
K112102, K120450
K102469
ESSURE - CLINICAL STUDIES
NDA 022304
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/12/2013
09/11/2013
09/09/2013
09/10/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
Pending Action
Pending Action
Delogged (not a FOIA Request)
Delogged (not a FOIA Request)
Closed
Closed
Pending Action
Partial Response
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Due Date
Lorraine Barde
Ortho Care
South Carolina Attorney General's Office
South Carolina Attorney General's Office
Regions Hospital
CBS NEWS
Medos Medizintechnik AG
TAYLOR, WENDY
James Alexander Corporation
Steptoe & Johnson LLP
Gary Syring
FOI Services, Inc.
NA
Horizon Pharma, Inc.
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 5 of 46
2013-7132
2013-7133
2013-7134
2013-7135
2013-7136
2013-7137
2013-7138
2013-7139
2013-7140
2013-7141
2013-7142
2013-7143
2013-7144
2013-7145
2013-7146
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
K122389
K130932
P850007/S005
P850007/S004
K092240
NDA 202515
ANDA 090431
ALCON LABORATORIES, CORK, IRELAND - EIR 02/21/2011 - 02/24/2011
HENRY FRAZER, PHARMD, MONTGOMERY, AL - 483 09/24/2012 - 10/03/2102
HILITE 7000, 7000 LT 510K
OXYELITE PRO - AERS
BIOMARIN - 483, REPSONSE, EIR 01/01/2013 - 09/05/2013
ZIMLAX - CORR, SUSPENSION, STUDIESETC
FDA STAFF MANUAL GUIDE 4850.7
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD - APPROVAL RECS FOR HIGH PRESSURE SYRINGES
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
09/09/2013
09/09/2013
09/09/2013
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
No Record(s)
Pending Action
Pending Action
Pending Action
Due Date
Bang, Eun
ORTHOFIX INC.
ORTHOFIX INC.
Orthofix Inc.
Sol Enterprises
FOI Services, Inc.
LACHMAN CONSULTANT SERVICES, INC.
Alcon Laboratories, Inc.
TC Consulting
Medos Medizintechnik AG
THE QUEEN'S MEDICAL CENTER
WELLS FARGO
Humane Society of the United States
MERRIMACK PHARMACEUTICALS INC
LexisNexis CourtLink Document Retrieval
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDRH/OCER/DFOI/
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/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
CVM/OCD/
FDA/OC/OES/
FDA/OC/OES/DDM/
FDA/OMPT/CDRH/OCER/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 6 of 46
2013-7147
2013-7148
2013-7149
2013-7150
2013-7151
2013-7152
2013-7153
2013-7154
2013-7155
2013-7156
2013-7157
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
IMPORT RECS 7/1/13 TO PRESSENT
MT HEALTHY HATCHERIES - SALMONELLA CONTAMINATION INVESTIGATION RECS 4/11
INDIVIDUAL RECS
LIST OF SPECIAL GOVERNMENT EMPLOYEES WHO COULD SERVE AS TEMPORARY VOTING MEMBERS FOR FDA A/C MTGS
XELLIA PHARMS - BACITRACIN CORR
LIN'S WAHA USA INTERNATIONAL CORP - ENTRY #U79-1682226-6 LAB RPTS, EIRS, 483S, ETC
LIN'S ENTERPRISE (USA) INC - ENTRY #ES3-2070142-9 LAB RPTS, EIRS, 483S, ETC
LED INTELLECTUAL PROPERTIES LLC - LIGHTSTIM K120775, K101190
OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION INC - TOLVAPTAN COMPLETE RESP LTR8/29/13
DETROIT RECS - MINOR DELETIONS
LOS ANGELES RECS - MINOR DELETIONS
Action Offices Status /Status Date
09/09/2013
09/13/2013
09/09/2013
09/10/2013
09/13/2013
09/09/2013
09/09/2013
09/10/2013
09/12/2013
09/12/2013
09/10/2013
Acknowledgement Letter
Withdrawn Closed w/o Charges
Closed (Fee-related)
Partial Response
Closed Denial
Acknowledgement Letter
Acknowledgement Letter
Closed
Closed Denial
Partial Denial
Partial Denial
Due Date
GLOBAL TRADE INTELLIGENCE INC
HEEKIN & HEEKIN
DANYSH, KURT
HOGAN LOVELLS LLP
WARNER NORCROSS & JUDD LLP
COWAN LIEBOWITZ & LATMAN PC
COWAN LIEBOWITZ & LATMAN PC
MORGAN LEWIS & BOCKIUS LLP
CINIMERA, KRISTA
ROLL LAW GROUP PC
ROLL LAW GROUP PC
ORA/
FDA/OGROP/ORA/ORO/DIOP/
FDA/OF/CFSAN/OCD/EOS/
FDA/OC/OES/DFOI/
CVM/OCD/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CTP/OD/
OC/OCC/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OF/CFSAN/OCD/EOS/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 7 of 46
2013-7158
2013-7159
2013-7160
2013-7161
2013-7162
2013-7163
2013-7164
2013-7165
2013-7166
2013-7167
2013-7168
2013-7169
2013-7170
2013-7171
2013-7172
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
MARROKO VALLEY LLC - ENTRY #BYX00637516, #BYX00633887 NOTICES FOR REQUEST OF INFORMATION (CF28), FDA NOTICE OF ACTION, CBP REDELIER NOTICES (CF4647), ETC
K972768
TOBACCO TRIBAL COMPLIANCE OUTREACH AND COMMUNICATIONS FDA-13-223-SOL-00071; THIRD PARTY AUDIT RECALL 12-223-SOL-00100
BELCHER PHARMACEUTICALS, LARGO, FL - 483
CONSUMER COMPLAINT 115081
NDA 200533
HHSF223201110113A
CARDIOMEMS' CHAMPION HF MONITORING SYSTEM - ADDITIONAL DATA SUBMISSION
VACCINE LICENSE NUMBER 3
OPTHALMIC DEVICES PANEL - TRANSCRIPTS 01/01/1995 - 12/31/1996
IND 15376
HDE H010005
FAP 5B3894, 8B4071
OSIRIS THERAPEUTICS, COLUMBIA, MD- 483, WARNING LETTER, UNTITLED LETTER
K030197
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/11/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Acknowledgement Letter
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Due Date
ROANOKE CLAIMS SERVICES
ORTHOFIX INC.
MCH Consulting Services
FDANEWS
York Williams, LLP
Horizon Pharma, Inc.
FEFA LLC
LAZARD CAPITAL MARKETS
FOI Services, Inc.
Richard B. Smith, Ph.D.
Kerry Thacker
Newcastle University
FOI Services, Inc.
Great Point Partners, LLC
ORTHOFIX INC.
ORA/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
FDA/OGROP/ORA/SW-FO/SWID/SWID-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OO/OFBA/OAGS/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
ORA/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OO/OFBA/OAGS/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OC/OES/DDM/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OMPT/CDRH/OCER/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 8 of 46
2013-7173
2013-7174
2013-7175
2013-7176
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
Subject
PHARMEDIUM SERVICES, LLC - INSPECTION RECS
K011965
TISSUE REFERENCE GROUP RECOMMENDATION DOCUMENTS
ANDA 091189
Action Offices Status /Status Date
09/09/2013
09/09/2013
09/09/2013
09/09/2013
Closed
Pending Action
Pending Action
Pending Action
Due Date
Huntington Memorial Hospital Inpatient Pharmacy
ORTHOFIX INC.
TissueTech, Inc.
Greg Allison
FDA/OC/OES/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 9 of 46
2013-7177
Control #
09/09/2013
Recd Date / Requester
10/07/2013
Subject
NEW ENGLAND CORD BANK - INSPECTION RECS 01/01/2013 - 09/08/2013
Action Offices Status /Status Date
09/09/2013
Pending Action
Due Date
Megan Healey FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 10 of 46
Control # Recd Date / Requester SubjectAction Offices Status /Status DateDue Date
CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 11 of 46
2013-7178
Control #
09/09/2013
Recd Date / Requester
10/07/2013
Subject
VIACORD - INSPECTION RECS 01/01/2013 - 09/08/2013
Action Offices Status /Status Date
09/09/2013
Pending Action
Due Date
Megan Healey FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 12 of 46
2013-7179
2013-7180
2013-7181
2013-7182
2013-7183
2013-7184
2013-7185
2013-7186
2013-7187
2013-7188
Control #
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
Recd Date / Requester
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/07/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
Subject
CORD BLOOD REGISTRY - INSPECTION RECS 01/01/2013 - 09/08/2013
K083421
FOIA REQUEST LOG 9/2/2013 TO 9/6/2013
K121434
JAMES C FREEMAN, MD - RESPONSE TO 483
THE SCIENCE SOURCE - ANNUAL REPORTS FOR RADIATION EMITTING PRODUCTS 06/30/2012 - 09/07/2013
BIOGEN IDEC, RESEARCH TRIANGLE PARK, NC - 483S 8/1-31/13
KAWKNAD MANUFACTURING INDUSTRIES INC, ALEXANDRIA, VA; BARR LABORATORIES INC (TEVA), FOREST, VA; TETRACORE INC, ROCKVILLE, MD, ETC - 483S 8/1-31/13
RSB SPINE LLC, CLEVELAND, OH - 483S 8/1-31/13
ARJOHUNTLEIGH INC, SAN ANTONIO, TX; RETRACTABLE TECHNOLOGIES INC,LITTLE ELM, TX; OTOTRONIX LLC, SPRING, TX, ETC - 483S 8/1-31/13
Action Offices Status /Status Date
09/16/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/09/2013
09/10/2013
09/10/2013
09/12/2013
09/10/2013
No Record(s)
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Acknowledgement Letter
Acknowledgement Letter
Closed
Acknowledgement Letter
Due Date
Megan Healey
Philips Healthcare Inc (Cleveland)
FDANEWS
Philips Healthcare Inc (Cleveland)
Steve Unwin
TEL-Atomic Inc
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
CB/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 13 of 46
2013-7189
Control #
09/10/2013
Recd Date / Requester
10/08/2013
Subject
CME AMERICA LLC, GOLDEN, CO; PROVIDENCE GLOBAL MEDICAL INC, SALT LAKE CITY, UT; CORGENIX INC, BROOMFIELD, CO, ETC - 483S 8/1-31/13
Action Offices Status /Status Date
09/10/2013
Acknowledgement Letter
Due Date
FDA NEWS FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 14 of 46
2013-7190
2013-7191
2013-7192
2013-7193
2013-7194
Control #
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
Recd Date / Requester
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
Subject
TANGENT MEDICAL TECHNOLOGIES, INC, ANN ARBOR, MI; KING SYSTEMS CORP, NOBLESVILLE, IN; KREMERS URBAN PHARMACEUTICALS INC, SEYMOUR, IN, ETC - 483S 8/1-31/13
GAMBRO RENAL PRODUCTS INC, DAYTONA BEACH, FL; BIOMET 3I LLC, PALM BEACH GARDENS, FL; FIBER OPTIC CABLES INC, LARGO, FL, ETC - 483S 8/1-31/13
MAYNE PHARMA INTERNATIONAL PTY LTD, SALISBURY SOUTH AUSTRALIA; LABORATORIOS JALOMA SA DE CV, GUADALAJARA, MEXICO; MERK SA DE CV, NAUCALPAN DE JUAREZ, MEXICO, ETC - 483S 8/1-31/13
MP BIOMEDICALS ASIA PACIFIC PTD LTD, SINGAPORE; PHILIPS & NEUSOFT MEDICAL SYSTEMS CO LTD, SHENYANG, CHINA; CHEEN HOUNG ENTERPRISE CO LTD, TAIPEI, TAIWAN, ETC - 483S 8/1-31/13
HOSPIRA INC, MCPHERSON, KS; WEXFORD LABS INC, KIRKWOOD, MO; CERTIFIED SAFETY MFG INC, KANSAS CITY, MO - 483S 8/1-31/13
Action Offices Status /Status Date
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Due Date
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
CB/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 15 of 46
2013-7195
Control #
09/10/2013
Recd Date / Requester
10/08/2013
Subject
SHIRE HUMAN GENETIC THERAPIES INC, CAMBRIDGE, MA; PHARMAGEN LABORATORIES INC, STAMFORD, CT; IMAGE DIAGNOSTICS INC, FITCHBURG, MA, ETC - 483S 8/1-31/13
Action Offices Status /Status Date
09/10/2013
Acknowledgement Letter
Due Date
FDA NEWS FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 16 of 46
2013-7196
2013-7197
Control #
09/10/2013
09/10/2013
Recd Date / Requester
10/08/2013
10/08/2013
Subject
PHARMACY CREATIONS, RANDOLPH, NJ; NOVEL LABORATORIES INC, SOMERSET, NJ; PROSEC PROTECTION SYSTEMS INC, LAKEWOOD, NJ - 483S 8/1-31/13
KEYSTONE LABORASTORIES INC, MEMPHIS, TN; GENERAL HEARING INSTRUMENTS INC, HARAHAN, LA - 483S 8/1-31/13
Action Offices Status /Status Date
09/10/2013
09/10/2013
Acknowledgement Letter
Acknowledgement Letter
Due Date
FDA NEWS
FDA NEWS
CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 17 of 46
2013-7198
Control #
09/10/2013
Recd Date / Requester
10/08/2013
Subject
ULTRALAB LABORATORIES INC, HIGHLAND, NY; ESTEE LAUDER IN (LEN RON MFG), MELVILLE, NY; ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY, ETC - 483S 8/1-31/13
Action Offices Status /Status Date
09/10/2013
Acknowledgement Letter
Due Date
FDA NEWS FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 18 of 46
2013-7199
2013-7200
2013-7201
2013-7202
2013-7203
2013-7204
2013-7205
2013-7206
2013-7207
2013-7208
2013-7209
2013-7210
Control #
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
Recd Date / Requester
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
Subject
LANNETT COMPANY INC, PHILADELPHIA, PA; SIGMA PHARM LABORATORIES LLC, BENSALEM, PA - 483S 8/1-31/13
AMPAC FINE CHEMICALS LLC, RANCHO CORDOVA, CA - 483S 8/1-31/13
GREENWAY RESEARCH LAB, BURNSVILLE, MN; FONTAROME CHEMICAL INC, ST FRANCIS, WI; FONTAROME CHEMICAL INC, ST FRANCIS, WI; CONTINENTAL MEDICAL LABS INC, WATERFORD, WI - 483S 8/1-31/13
KIRKMAN GROUP INC, LAKE OSWEGO, OR - 483S 8/1-31/13
PFIZER PHARMACEUTICALS INC, BARCELONETA, PR - 483S 8/1-31/13
LAERDAL MEDICAL A/S, STAVANGER, NORWAY 8/1-31/13
SANITOR CORP, HUNTINGTON BEACH, CA; ALLIANCE MEDICAL PRODUCTS INC,IRVINE, CA; CAPCO CUSTOM PACKAGING INC, SANTA FE SPRINGS, CA, ETC - 483S 8/1-31/13
K954465
K131619
K113776
Letters from state legislators to Commissioner Margaret Hamburg regardingpotential regulation of menthol cigarettes
QUINCY BIOSCIENCE, MADISON, WI - WARNING LETTER RECS
Action Offices Status /Status Date
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/17/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/12/2013
09/10/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
No Record(s)
Acknowledgement Letter
Pending Action
Pending Action
Pending Action
No Record(s)
Pending Action
Due Date
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
FDA NEWS
STRYKER ENDOSCOPY
JNC CORPORATION
Symmetry Medical Manufacturing, Inc.
POLITICO
Freelance writer & editor Marc Eisen
DCB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
FDA/OMPT/CDRH/OCER/DFOI/
ORA/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/
FDA/OMPT/CTP/OD/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 19 of 46
2013-7211
Control #
09/10/2013
Recd Date / Requester
10/08/2013
Subject
LIST OF DIALYSIS CLINICS IN US USING FESENIUM DIALYSATE GRANYFLO AND/OR NATURALYTE 07/01/2003 - 12/30/2012
Action Offices Status /Status Date
09/10/2013
Pending Action
Due Date
Dold, Patty FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 20 of 46
2013-7212
2013-7213
2013-7214
2013-7215
2013-7216
2013-7217
2013-7218
2013-7219
2013-7220
2013-7221
2013-7222
2013-7223
2013-7224
2013-7225
2013-7226
2013-7227
Control #
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
Recd Date / Requester
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
10/08/2013
Subject
WEST PHARMACEUTICALS, JERSEY SHORE, PA - EIR 11/03/2011 - 09/09/2013
K083707
FAP 7C0283
PATHEON PHARMACEUTICALS INC, CINCINNATI, OH - EIR 01/01/2011 - 09/09/2013
WOCKHARDT, INDIA - 483 07/01/2013 - 09/10/2013
COMMISSIONED CORP INVESTIGATION CRITERIA
INDIVIDUAL RECS
DOXEPIN ANDA 71-673; 71-674; 71-675; 71-676; 71-685; 71-686 APRVL 1/5/88
MARQIBO KIT (VINCRISTINE SULFATE) NDA 02-497 APRVL 8/9/12 - RVW
BLOXIVERZ (NEOSTIGMAINE METHYL SULPHATE) NDA 04-078 - APRVL, LBLG, MEDICAL RVW, PHARMACOLOGY RVW, CHEMISTRY RVW
REDACTED MEDWATCH RPTS 8/13
K030813
SURGICAL MESH FOR POP/SUI REPAIR -MDR RPTS 2000 TO PRESENT
SICOR DE MEXICO SA DE CV, MEXICO - 483 7/13
TRANSCRIPT OF MTG OF BLOOD ADVISORY COMMITTEE 12/2/93
OSPHENA (OSPEMIFENE) PHARMACOLOGY RVW UNDEDACTED 4/25/12
Action Offices Status /Status Date
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/11/2013
09/18/2013
09/18/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/10/2013
09/12/2013
09/10/2013
09/10/2013
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Referral (Outside FDA)
Referral (Outside FDA)
Acknowledgement Letter
Withdrawn Closed w/o Charges
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Closed
Acknowledgement Letter
Acknowledgement Letter
Due Date
flynn, joy
STRYKER ENDOSCOPY
KnipBio
VeroScience LLC
Dheeresh Pathak
HERBST, JACQUELINE
HERBST, JACQUELINE
DAVA PHARMACEUTICALS INC
HOLLAND, CHRIS
EAS CONSULTING GROUP LLC
INSTITUTE FOR SAFE MEDICATION PRACTICES
HANGZHOU CONOD MEDICAL CO LTD
INDAGO GROUP
INDENA USA INC
POMERANTZ HUFFORD ET AL
SHIONOGI INC
CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OC/OES/DFOI/
FDA/OC/OES/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/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OC/OES/DDM/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 21 of 46
2013-7228
2013-7229
2013-7230
2013-7231
2013-7232
2013-7233
2013-7234
2013-7235
2013-7236
2013-7237
2013-7238
2013-7239
2013-7240
2013-7241
Control #
09/10/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
Recd Date / Requester
10/08/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
Subject
MERCK & CO - GLUCAGON LIKE PEPTIDE THERAPIES INVESTIGATIONS
ANDA 77-425 - AMENDMENT COVER LTRS 4/13/12, 8/1/12, 8/8/12, 8/15/12, 9/28/12, 6/11/13 & 7/30/13
NEXT SEAFOOD - RPTS, CORR, INVESTIGATION RECS, ETC
RESULTS OF THE MEDSUN SURVEY REGARDING THE DA VINCI SURGICAL SYS
SURGICAL MESH - EMAIL NOTIFICATIONS OR MAILINGS SENT TO PHYSICIANS 1/08 AND 1/09
LEAN CUISINE, NUTRISYSTEM, HEALTHY CHOICE, ETC - CAERS 1969 TO 2013
EDAP TMS SA CORP - ABLATHERM HIFUDVC MTG RECS 6/3/13
DRUG MFRS, LABLERS, REPACKERS, ETC - FOREIGN AND DOMESTIC INSPS 3/1/13 TO PRESENT
CURTIS HORN MD, SAN ANTONIO, TX - EIR, 483, CO RESP 2/13/12
GENESIS PHARMACEUTICALS INC, HENDERSON, NV - EIR, 483, CO RESP 9/13/12
DAVID J PORTMAN MD, COLUMBUS,OH -EIR, 483, CO RESP 10/26/12
CENEXI LABORATORIES THISSEN SA, BRAINE L'ALLEUD, BELGIUM - EIR, 483,CO RESP 7/17/12
BIORELIANCE CORP, ROCKVILLE, MD - EIR, 483, CO RESP 7/3/12
AUXILIUM PHARMACEUTICALS INC, HORSHAM, PA - EIR, 483, CO RESP 7/6/12
Action Offices Status /Status Date
09/11/2013
09/11/2013
09/17/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/12/2013
09/11/2013
09/11/2013
09/11/2013
09/13/2013
09/16/2013
09/11/2013
Withdrawn Closed w/o Charges
Acknowledgement Letter
Partial Response
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Closed
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Closed
Closed
Acknowledgement Letter
Due Date
PARKER & WAICHMAN ATTYS
COVINGTON & BURLING LLP
GUY KORNBLUM & ASSOCIATES
DEERFIELD INSTITUTE
ZUKOWSKI ROGERS FLOOD & MCARDLE LAW OFCS
FRIEDMAN, ROBERT
HUNTINGTON, DAVID G
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OF/CFSAN/OCD/EOS/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDRH/OCER/DFOI/
ORA/ORM/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 22 of 46
2013-7242
Control #
09/11/2013
Recd Date / Requester
10/09/2013
Subject
WILLIAM M KUFS MD, SARATOGA SPRINGS, NY - EIR, 483, CO RESP 2/9/12
Action Offices Status /Status Date
09/11/2013
Acknowledgement Letter
Due Date
THOMSON REUTERS FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 23 of 46
Control # Recd Date / Requester SubjectAction Offices Status /Status DateDue Date
DCB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 24 of 46
2013-7243
Control #
09/11/2013
Recd Date / Requester
10/09/2013
Subject
VERTEX PHARMACEUTICALS INC, CAMBRIDGE, MA - EIR, 483, CO RESP 1/13/12
Action Offices Status /Status Date
09/11/2013
Acknowledgement Letter
Due Date
THOMSON REUTERS FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 25 of 46
2013-7244
2013-7245
Control #
09/11/2013
09/11/2013
Recd Date / Requester
10/09/2013
10/09/2013
Subject
UNICHEM LABORATORIES LTD, GOA, INDIA - EIR, 483, CO RESP 4/6/12
TAKEDA PHARMACEUTICAL CO LTD, OSAKA, JAPAN - EIR, 483, CO RESP 8/2/12
Action Offices Status /Status Date
09/11/2013
09/13/2013
Acknowledgement Letter
Withdrawn Closed w/o Charges
Due Date
THOMSON REUTERS
THOMSON REUTERS
CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 26 of 46
2013-7246
Control #
09/11/2013
Recd Date / Requester
10/09/2013
Subject
STERIS ISOMEDIX SERVICES INC, SANDY, UT - EIR, 483, CO RESP 3/21/12
Action Offices Status /Status Date
09/11/2013
Acknowledgement Letter
Due Date
THOMSON REUTERS FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 27 of 46
2013-7247
2013-7248
2013-7249
2013-7250
2013-7251
2013-7252
2013-7253
2013-7254
2013-7255
2013-7256
2013-7257
Control #
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
Recd Date / Requester
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
10/09/2013
Subject
SANOFI-AVENTIS US LLC, ST LOUIS, MO- EIR, 483, CO RESP 3/14/12
ROBIN KROLL MD, SEATTLE, WA - EIR, 483, CO RESP 12/20/12
PFIZER PHARMACEUTICALS LLC, VEGA BAJA, PR - EIR, 483, CO RESP 8/10/12
OAKWOOD LABORATORIES LLC, SOLON, OH - EIR, 483, CO RESP 9/20/12
NESHER PHARMACEUTICALS (USA) LLC,BRIDGETON, MO - EIR, 483S, CO RESP 12/6/12
ABBVIE BIOTECHNOLOGY LTD, BARCELONETA, PR - EIR, 483, CO RESP 7/2/12
DAKOTA LABORATORIES LLC, MITCHELL, SD - EIR, 483, CO RESP 4/5/12
DAKOTA LABORATORIES LLC, MITCHELL, SD - EIR, 483, CO RESP 8/31/11
DAKOTA LABORATORIES LLC, ST LOUIS,MO - EIR, 483, CO RESP 6/22-24/10
STEWART PHARMACEUTICALS INC (STEWART COMPOUNDING PHARMACY),FAYETTEVILLE, NC - EIR, 483, CO RESP 3/18-25/13
HENRY A FRAZER PHARM D, MONTGOMERY, AL - EIR, 483, CO RESP 9/24/12-10/3/12
Action Offices Status /Status Date
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
09/11/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Due Date
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 28 of 46
2013-7258
Control #
09/12/2013
Recd Date / Requester
10/10/2013
Subject
NELSON LABS, SALT LAKE CITY, UT - EIR, 483, RESPONES 09/09/2008 - 09/09/2013
Action Offices Status /Status Date
09/12/2013
Pending Action
Due Date
BAYER HEALTHCARE FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 29 of 46
2013-7259
2013-7260
2013-7261
2013-7262
2013-7263
2013-7264
2013-7265
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
AAI PHARMA, WILMINGTON, NC - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
IRVINE PHARMACEUTICAL, IRVINE, CA - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
EUROFINS LANCASTER LABORATORIES,LANCASTER, PA - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
COVIDIEN, AUGUSTA, GA - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
COVIDIENT, DELAND, FLA - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
TERUMO MEDICAL CORPORATION, PHOENIX, AZ -EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
BD MEDICAL SYSTEMS, FRANKLIN LAKES, NJ - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Due Date
BAYER HEALTHCARE
Berkeley Healthcare
BAYER HEALTHCARE
BAYER HEALTHCARE
BAYER HEALTHCARE
BAYER HEALTHCARE
BAYER HEALTHCARE
CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 30 of 46
2013-7266
Control #
09/12/2013
Recd Date / Requester
10/10/2013
Subject
BD MEDICAL, SANDY, UT - EIR, 483, RESPONSE 09/08/2008 - 09/08/2013
Action Offices Status /Status Date
09/12/2013
Pending Action
Due Date
BAYER HEALTHCARE FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 31 of 46
2013-7267
2013-7268
2013-7269
2013-7270
2013-7271
2013-7272
2013-7273
2013-7274
2013-7275
2013-7276
2013-7277
2013-7278
2013-7279
2013-7280
2013-7281
2013-7282
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
PENTA MANUFACTURING COMPANY, LIVINGSTON, NJ - EIR, 483, RESPONSE 09/09/2010 - 09/09/2013
INADA 010-046-Hoo6 - MANUFACTURING CHEMISTRY SECTION
ESSURE - POST APPROVAL STUDIES
K100635
K120012
K071079
FCN 62
K954707
K050907
K933433
SBA 20589 S019
SBA 20589 S17
NDA 201292 S 001
DKT. 80N-0146
FCN 185
LISTING OF DESI PRODUCTS CURRENTLY ON THE MARKET
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Pending Action
Pending Action
Pending Action
Closed
Withdrawn Closed w/o Charges
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Due Date
James Alexander Corporation
Freeport-McMoRan Sales Company
Myers, William R
Ansell Healthcare Products LLC
FOI Services, Inc.
FOI Services, Inc.
Cheeseman, Mitch
Martos, Arden
Martos, Arden
DANIEL MARTOS
INC RESEARCH CONSULTING & SUBMISSIONS
INC RESEARCH CONSULTING & SUBMISSIONS
INC RESEARCH CONSULTING & SUBMISSIONS
The Law Office of Katherine Giannamore, PA
Cheeseman, Mitch
Daniels, Michelle
CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
CVM/OCD/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
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/OC/OES/DDM/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 32 of 46
2013-7283
2013-7284
2013-7285
2013-7286
2013-7287
2013-7288
2013-7289
2013-7290
2013-7291
2013-7292
2013-7293
2013-7294
2013-7295
2013-7296
2013-7297
2013-7298
2013-7299
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
NDA 022244 - ACTION LETTER
BLA 103000 S5050
K032833
DR REDDY QUENTIAPINE FUMARATE - AERS
ANDA 078854
K112094
K990278
K032054
K060808
K924348
K971247
JABONES PARDO SA MADRID, SPAIN - EIRS, 483S, CO RESP 03/11-14/113
IBI-ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA, APRILLA, ITALY - EIRS, 483S, CO RESP 10/05/12
CATALENT PHARMA SOLUTIONS LLC, SOMERSET, NJ - EIRS, 483S, CO RESP 12/19/12
AMGEN INC, THOUSAND OAKS, CA - EIRS, 483S, CO RESP 12/12/12
SA ANALYTICAL LLC, MUNDELEIN, IL - EIRS, 483S, CO RESP 01/16/13
LOWELL ROGER, EVANSVILLE, IN - EIRS, 483S, CO RESP 01/03/13
Action Offices Status /Status Date
09/13/2013
09/13/2013
09/12/2013
09/12/2013
09/20/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/18/2013
09/13/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Closed
Duplicate Request
Pending Action
Pending Action
Closed
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Withdrawn Closed w/o Charges
Withdrawn Closed w/o Charges
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Due Date
The National Academies (Institute of Medicine)
FOI Services, Inc.
Infinite Biomedical Technologies, LLC
none
VersaPharm Inc.
BIO TEX INC
BIO TEX INC
BIO TEX INC
BIO TEX INC
BIO TEX INC
BIO TEX INC
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
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/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
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/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 33 of 46
2013-7300
2013-7301
2013-7302
Control #
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
Subject
INTERSTATE BLOOD BANK INC, PHILADELPHIA, PA - EIRS, 483S, CO RESP 03/12/13
HOXWORTH BLOOD CENTER, FORT MITCHELL, KY - EIRS, 483S, CO RESP 01/07/13
CARTER BLOOD CARE - CEDAR HILL DONATION CENTER, CEDAR HILL, TX - EIRS, 483S, CO RESP 02/02/13
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Due Date
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 34 of 46
2013-7303
Control #
09/12/2013
Recd Date / Requester
10/10/2013
Subject
GRIFOLS THERAPEUTICS INC, MELVILLE, NY - EIRS, 483S, CO RESP 09/02/12
Action Offices Status /Status Date
09/12/2013
Acknowledgement Letter
Due Date
THOMSON REUTERS FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 35 of 46
2013-7304
2013-7305
2013-7306
2013-7307
2013-7308
2013-7309
2013-7310
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
AULTMAN HOSPITAL, CANTON, OH - EIRS, 483S, CO RESP 02/08/13
RARITAN PHARMACEUTICALS INC, EASTBRUNSWICK, NJ - EIRS, 483S, CO RESP 09/19/12
MONOSOL RX LLC, PORTAGE, IN - EIRS,483S, CO RESP 09/13/12
LTS LOHMANN THERAPY SYSTEMS CORP, WEST CALDWELL, NJ - EIRS, 483S, CO RESP 09/11/12
BETHESDA MEMORIAL HOSPITAL IRB, BOYNTON BEACH, FL - EIRS, 483S, CO RESP 09/07/12
YONSUNG FINE CHEMICALS CO LTD, GYEONGGI-DO, SOUTH KOREA - EIRS, 483S, CO RESP 10/25/12
APTUIT (SCIENTIFIC OPERATIONS) LLC, HARRISONVILLE, MO - EIRS, 483S, CO RESP 11/14/12
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/13/2013
09/12/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Withdrawn Closed w/o Charges
Acknowledgement Letter
Due Date
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
DCB/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 36 of 46
2013-7311
Control #
09/12/2013
Recd Date / Requester
10/10/2013
Subject
BOSTON ANALYTICAL LINC, SALEM, NH - EIRS, 483S, CO RESP 11/09/12
Action Offices Status /Status Date
09/12/2013
Acknowledgement Letter
Due Date
THOMSON REUTERS FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 37 of 46
2013-7312
2013-7313
2013-7314
2013-7315
2013-7316
2013-7317
2013-7318
2013-7319
2013-7320
2013-7321
2013-7322
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
MARK B FARIES MD, SANTA MONICA, CA- EIRS, 483S, CO RESP 11/30/12
SIGHTLIFE, SEATTLE, WA - EIRS, 483S, CO RESP 12/17/12
ATLANTA BLOOD SERVICES, MARIETTA, GA - EIRS, 483S, CO RESP 03/20/13
MERICON INDUSTRIES INC, PEORIA, IL -EIRS, 483S, CO RESP 04/27/12
LAMBDA RESEARCH INC, CINCINNATI, OH - EIRS, 483S, CO RESP 04/27/12
JACOBUS PHARMACEUTICAL COMPANY, INC, PLAINSBORO, NJ - EIRS, 483S, CO RESP 04/16/12
ADVANCED BRAIN MONITORING INC, CARLSBAD, CA - K120450
IMPLEMENTATION OF SECTION 216 & THE REQUIREMENTS TO FULFILL SIMILARITY OF A PROD IN TO THE APRVD PRODIN CONTEXT OF EVOKING SECTION 216
OXCARBAZEPINE ORAL SUSPENSION 300 MG/5ML ANDA 202-961 - APRVL LTR,LBLG, MEDICAL OFFICERS RVWS, ETC
DIVESTITURE OF PROHIBITED HOLDINGS
USPS LABS LLC - 483S, RESP, ATTACHMENTS, EXHIBITS, ETC 02/21/12
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/20/2013
09/12/2013
09/12/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Closed
Acknowledgement Letter
Acknowledgement Letter
Due Date
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
THOMSON REUTERS
GENERAL SLEEP CORP
M SQUARED ASSOCIATES INC
EAS CONSULTING GROUP LLC
MUCKROCK NEWS
QUELLER FISHER ET AL
CB/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
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/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OC/OES/DFOI/
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 38 of 46
2013-7323
Control #
09/12/2013
Recd Date / Requester
10/10/2013
Subject
PHARMAGEN LABS - CMPLNT
Action Offices Status /Status Date
09/12/2013
Acknowledgement Letter
Due Date
PHARMAGEN LABS FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 39 of 46
2013-7324
2013-7325
2013-7326
2013-7327
2013-7328
2013-7329
2013-7330
2013-7331
2013-7332
2013-7333
2013-7334
2013-7335
2013-7336
2013-7337
2013-7338
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
PRESCRIPTION DRUG PROMOTION - TALK PAPER 7/18/91; PFIZER INC - LTR 7/13/82; BRISTO-MYERS SQUIB - REGULATORY LTR 1/25/91
BAYER CORP - ENTERIC COATED ASPRIN RPTS, INVESTIGATIONS, STATEMENTS, ETC
METAGENICS INC - WARNING LTR 8/13/13
BK120012
SBA 20589 S015
INTUITIVE, SUNNYVALE, CA - 483 01/10/2000 - 09/11/2013
SAMUEL LN LEDERMAN MD - EIR, INTERNAL CORR, DETERMINATIONS
NDA 202379
FETZIMA (LEVOMILNACIPRAN) NDA 204-168 APRVL PKG
INTUITIVE SURGICAL - HOSPITAL AERS 01/01/2000 - 09/11/2013
FOIA SUMMARIES NADA 012-198, NADA 012-204
FDA Oral History Interview, Merrill - Part I ABOUT FDA
ALCON CUSI SA, BARCELONA, SPAIN - EIR 09/05/2011 - 09/09/2011
CIBA VISION, BATAM, INDONESIA - EIR 05/02/2011 - 05/05/2011
ALCON GRESHABER, SWITZERLAND - EIR 04/11/2011 - 04/14/2011
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/17/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/19/2013
09/12/2013
09/12/2013
09/18/2013
09/12/2013
09/12/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Hold
Pending Action
Pending Action
Acknowledgement Letter
Pending Action
Acknowledgement Letter
Closed Denial
Pending Action
Closed
Withdrawn Closed w/o Charges
Pending Action
Pending Action
Due Date
SIDLEY AUSTIN LLP
LIEFF CABRASER ET AL
OLSSON FRANK WEEDA TERMAN BODE MATZ
FOI Services, Inc.
INC RESEARCH CONSULTING & SUBMISSIONS
BLOOMBERG NEWS
ALTUS RESEARCH
INC RESEARCH CONSULTING & SUBMISSIONS
PUBLIC CITIZEN (HEALTH RESEARCH GROUP)
BLOOMBERG NEWS
LUITPOLD PHARMACEUTICALS, INC.
none
Alcon Laboratories, Inc.
Alcon Laboratories, Inc.
Alcon Laboratories, Inc.
CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
CVM/OCD/
OM/OSS/OPILS/FDAHO/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 40 of 46
2013-7339
2013-7340
2013-7341
2013-7342
2013-7343
2013-7344
2013-7345
2013-7346
2013-7347
2013-7348
2013-7349
2013-7350
2013-7351
2013-7352
2013-7353
2013-7354
2013-7355
2013-7356
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
ALCON LABS, HUNTINGTON, WV - EIR 09/23/2011 - 05/31/2011
CIBA VISION, GROSSWALLASTADT, GERMANY - EIR 06/27/2011 - 08/31/2011
DAILY LOG 8/19-23/13
DAILY LOG 8/12-16/13
DAILY LOG 8/12-16/13
DAILY CLOSED LOG 8/19-23/13
DAILY LOG 8/12-16/13
DAILY LOG 8/19-23/13
DAILY CLOSED LOG 8/19-23/13
DAILY CLOSED LOG 8/12-16/13
DAILY CLOSED LOG 8/19-23/13
DAILY LOG 8/19-23/13
DAILY LOG 8/12-16/13
DAILY CLOSED LOG 8/12-16/13
DAILY CLOSED LOG 8/12-16/13
DAILY LOG 8/19-23/13
DAILY LOG 8/19-23/13
DAILY LOG 8/12-16/13
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Pending Action
Pending Action
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Due Date
Alcon Labs, Inc.
Alcon Laboratories, Inc.
CanReg, Inc.
CanReg, Inc.
CanReg, Inc.
CanReg, Inc.
WOLTERS KLUWER LAW & BUSINESS
WOLTERS KLUWER LAW & BUSINESS
WOLTERS KLUWER LAW & BUSINESS
WOLTERS KLUWER LAW & BUSINESS
FOI Services, Inc.
FOI Services, Inc.
FOI Services, Inc.
FOI Services, Inc.
FDA REVIEW/FDA WEBVIEW
FDA REVIEW/FDA WEBVIEW
DOMINION GROUP INC
DOMINION GROUP INC
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 41 of 46
2013-7357
2013-7358
2013-7359
2013-7360
2013-7361
2013-7362
2013-7363
2013-7364
2013-7365
2013-7366
2013-7367
2013-7368
2013-7369
2013-7370
2013-7371
2013-7372
2013-7373
Control #
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/12/2013
Recd Date / Requester
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
10/10/2013
Subject
DAILY LOG 8/19-23/13
DAILY LOG 8/12-16/13
DAILY LOG 8/19-23/13
DAILY LOG 8/12-16/13
2013-6078 - REQUEST LETTER
2013-6445 - REQUEST LETTER ONLY
2013-6700 - REQUEST LETTER ONLY
DAILY CLOSED LOG 8/12-16/13
2013-6606 - REQUEST LETTER ONLY
2013-6077 - REQUEST LETTER ONLY
2013-6229 - REQUEST LETTER ONLY
DAILY CLOSED LOG 8/19-23/13
DAILY CLOSED LOG 8/19-23/13
DAILY LOG 8/12-16/13
2013-6243 - REQUEST LETTER
2013-5959 - REQUEST LETTER
2013-6455 - REQUEST LETTER
Action Offices Status /Status Date
09/12/2013
09/12/2013
09/12/2013
09/12/2013
09/18/2013
09/18/2013
09/18/2013
09/12/2013
09/19/2013
09/18/2013
09/19/2013
09/12/2013
09/12/2013
09/12/2013
09/19/2013
09/18/2013
09/18/2013
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Due Date
WASHINGTON INFORMATION SOURCE
WASHINGTON INFORMATION SOURCE
Center for Regulatory Services, Inc.
Center for Regulatory Services, Inc.
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
JH BARR & ASSOCIATES LLC
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
JH BARR & ASSOCIATES LLC
JH BARR & ASSOCIATES LLC
JH BARR & ASSOCIATES LLC
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 42 of 46
2013-7374
2013-7375
2013-7376
2013-7377
2013-7378
2013-7379
2013-7380
2013-7381
2013-7382
2013-7383
2013-7384
2013-7385
2013-7386
2013-7387
2013-7388
2013-7389
Control #
09/12/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
Recd Date / Requester
10/10/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
Subject
2013-6001 - REQUEST LETTER
BAXTER BIODOME, MARSA, MALTA - EIR, 483, RESPONSES 09/09/2008 - 09/09/2013
MEDIMOP MEDICAL PRODUCTS, RAANANA, ISRAEL - EIR, 483, RESPONSES 09/09/2008 - 09/09/2013
BIOFARMITALIA, ITALY - EIR, 483, RESPONSES 09/09/2008 - 09/09/2013
EMD MILLIPORE CORPORATION, GIBBSTOWN, NJ - EIR, 483, RECALL 09/09/2009 - 09/09/2013
VETTER PHARMA FERTIGUNG, RAVENSBURG, GERMANY - EIR, 483, RESPONSES 09/09/2008 - 09/09/2013
VETTER PHARMA FERTIGUNG, LANGENARGEN, GERMANY - EIR, 483, RESPONSE 09/09/2008 - 09/09/2013
ESSURE - CLINICAL STUDIES
AMRESCO, SOLON, OH - EIR, 483, RECALL 09/01/2010 - 09/10/2013
NDA 17768
APPLIED PLASTICS, OAK CREEK, WI - EIR, 483, RECALL 09/01/2010 - 09/10/2013
AZATHIOPRINE - AERS
ESTRACE VAGINAL CREAM CLINICAL TRIALS INFORMATION 01/01/1984 - 09/10/2013
LIQUID PACKAGING RESOURCES, ATLANTA, GA - 483 01/01/2010 - 09/10/2013
DKT 2013-N-0778
OFFICE OF GENERIC DRUGS STATISTICAL REPORT - MOST RECENT
Action Offices Status /Status Date
09/19/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/18/2013
09/13/2013
09/13/2013
09/13/2013
09/18/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
Closed
Pending Action
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Pending Action
Due Date
MERCK & CO., INC.
BAYER HEALTHCARE
BAYER HEALTHCARE
BAYER HEALTHCARE
James Alexander Corporation
BAYER HEALTHCARE
BAYER HEALTHCARE
Shannon McOsker
James Alexander Corporation
Ansell Healthcare Products LLC
James Alexander Corporation
NEW YORK UNIVERSITY MEDICAL CENTER
Coleman, Jacqueline
David M. Pike
FOI Services, Inc.
WILBUR, ELLIOT
FDA/OC/OES/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OC/OES/DDM/
FDA/OMPT/CTP/OD/
FDA/OMPT/CDER/ORP/DIDP/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 43 of 46
2013-7390
2013-7391
2013-7392
2013-7393
2013-7394
2013-7395
Control #
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
Recd Date / Requester
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
Subject
FCN 1251
FDA FISH, FISHERY, AND SEAFOOD IMPORT INSPECTION, LABORATORY TESTING AND TOTAL IMPORT LINES OF ENTRY FOR FDA PRODUCT CODE 16
ZOLOFT - RECS RE BIRTH DEFECTS AND PREGNANCY
TAKEDA, SINGEN, GERMANY - EIR, 483 1/1/07 TO PRESENT
BLA 125320 007
LIST OF FACILITIES RE DIETARY SUPPLEMENT OR COMPONENT OF DIETARY SUPPLEMENT
Action Offices Status /Status Date
09/13/2013
09/13/2013
09/13/2013
09/17/2013
09/13/2013
09/13/2013
Pending Action
Pending Action
Pending Action
No Record(s)
Pending Action
Pending Action
Due Date
A Philip Leber Consulting
Food & Water Watch
ARNOLD & ITKIN LLP
INC RESEARCH CONSULTING & SUBMISSIONS
INC RESEARCH CONSULTING & SUBMISSIONS
COUNCIL FOR RESPONSIBLE NUTRITION
FDA/OF/CFSAN/OCD/EOS/
ORA/
FDA/OGROP/ORA/ORO/DIOP/
ORA/ORM/
ORA/ORM/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
ORA/
ORA/ORM/
FDA/OF/CFSAN/OCD/EOS/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 44 of 46
2013-7396
Control #
09/13/2013
Recd Date / Requester
10/11/2013
Subject
CHOBANI - LAB TEST RESULTS SUBMITTED TO FDA
Action Offices Status /Status Date
09/13/2013
Pending Action
Due Date
MILWAUKEE JOURNAL SENTINEL ORA/
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 45 of 46
2013-7397
2013-7398
2013-7399
2013-7400
2013-7401
2013-7402
2013-7403
2013-7404
2013-7405
2013-7406
2013-7407
2013-7408
2013-7409
2013-7410
2013-7411
Control #
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
Recd Date / Requester
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
Subject
JANUVIA, JANUMET - FOIA REQUESTS AND RECORDS
K091515
MICHAEL FOODS, INC, ELIZABETH, NJ - RECS RE OUTBREAK REPORT : 05/15/2010 - 08/15/2010
GILEAD SCIENCES - 483, EIR 01/01/2013 - 09/12/2013
NDA 022055
IND 66095
CORR BETWEEN FDA AND MANUFACTURERS OR DISTRIBUTORS OF PERSONAL SOUND AMPLIFICATION PRODUCTS RE SALE OF THOSE PRODUCTS 06/01/2012 - 09/13/2013
IND FOR XF-73
DEPUY - HIP IMPLANTS MDRS
KARMELSONIX - WIM PC MODEL 1010 K071955
BORN BRANDS - BABY WEDGE MTGS, WARNINGS
CIBA VISION CORPORATION, DULUTH, GA - EIR 09/01/2012 - 09/01/2013
CAFFEINE ADDED TO FOOD AND DRINKS - GRAS, CORR
PERSONALIZED PROTEIN POWDER
POTIGA (EZOGABINE) NDA 22-345
Action Offices Status /Status Date
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/16/2013
09/13/2013
09/13/2013
09/13/2013
09/19/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/16/2013
09/16/2013
Pending Action
Closed
Pending Action
Pending Action
Closed
Pending Action
Pending Action
Pending Action
Closed
Acknowledgement Letter
Acknowledgement Letter
Withdrawn Closed w/o Charges
Acknowledgement Letter
Closed
Closed (Fee-related)
Due Date
WESTLAW COURT EXPRESS
STRYKER CORP
Michael Foods, Inc.
WELLS FARGO
INNOVATIVE PHARMACEUTICALS, LLC
INNOVATIVE PHARMACEUTICALS, LLC
Hyman, Phelps & McNamara P.C.
Innovative Pharmaceuticals,LLC
HIGGINS, MILDRED
LATHAM & WATKINS LLP
JOHNSON WINTER ET AL
CIBA VISION Corporation
CENTER FOR SCIENCE IN THE PUBLIC INTEREST
GARDNER, JEFFREY
TORRENT PHARMA INC
CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
FDA/OC/OES/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OC/OES/DFOI/
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OMPT/CDRH/OCER/DFOI/
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
FDA/OF/CFSAN/OCD/EOS/
FDA/OC/OES/DFOI/
FDA/OC/OES/DFOI/
Query Result ReportRecords: 336
September 20, 2013 10:57 AMPage 46 of 46
2013-7412
2013-7413
2013-7414
2013-7415
2013-7416
2013-7417
2013-7418
2013-7419
2013-7420
2013-7421
2013-7422
2013-7423
Control #
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
Recd Date / Requester
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
10/11/2013
Subject
CHARLES RIVER LABORATORIES INC, WILMINGTON, MA - EIR 10/30/12-11/15/12
COPAXONE NDA 20-622/S083, S085; ADRENACLICK NDA 20-800/S023 - SBA
NEXIUM (ESOMEPRAZOLE) - APRVL, RVWS, CORR, WARNINGS
McCORMICK & COMPANY, HUNT VALLEY, MD - EIR MOST RECENT
PROCESADORA DE PRODUCTOS MARINOS DELIFISH SA, PUERTO MONTT, CHILE - LAB RPTS, ANALYTICALW/S, EIR, ETC
INDIVIDUAL RECS
INDIVIDUAL RECS
USE OF EMPLOYEE EDUCATION & TRAINING
PDMA 2008 TO PRESENT
ROSEMONT FARMS, PLANT CITY, FL - INSP
AMPIO - AMPION TYPE B PRE-BLA MTG MINS 10/29/13, LTR 9/6/13
2012-2202, 2012-2938, 2012-6232, ETC
Action Offices Status /Status Date
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/13/2013
09/19/2013
09/19/2013
09/18/2013
09/16/2013
09/13/2013
09/17/2013
09/13/2013
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Acknowledgement Letter
Closed
Closed
No Record(s)
Closed
Acknowledgement Letter
Withdrawn Closed w/o Charges
Acknowledgement Letter
Due Date
CHARLES RIVER LABS
WISLON SONSINI ET AL
CORY WATSON ET AL
HOGAN LOVELLS LLP
AKIN GUMP ET AL
CONWAY HOMER & CHIN-CAPLAN PC
CONWAY HOMER & CHIN-CAPLAN PC
SCHERR, CHAD .
PORZIO LIFE SCIENCES
FORD, LISA
ASCEND CAPITAL LLC
GARDNER, JEFFREY
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OC/OES/DDM/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
FDA/OF/CFSAN/OCD/EOS/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OC/OES/DFOI/
ORA/ORM/
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
FDA/OMPT/CDER/ORP/DIDP/
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
FDA/OC/OES/DFOI/