Oct 22, 2013 ... HAVEN, MI - EIR 02/12/2013 - 02/15/2013. ALBERMARLE CORPORATION,
SOUTH. HAVEN, MI - EIR 01/01/2012 - 01/31/2012.
Query Result Report Records: 100
Action Office: ALL Control #: Track: ALL
Received Via: BOTH Rec/Create Date: 09/30/2013
To
Due Date:
To
Signature:
Status Date:
To
Requester:
Requester Type:
Subject: Status: ALL Privacy: Special Interest: ALL
Category: ALL Entered By:
10/04/2013
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7795
09/30/2013
Reed, John H
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
ROYAL RAYMOND FIFE, SAN DIEGO, CA - INVESTIGATION RECS 01/01/1910 12/31/2012
Pending Action
YASMIN - AERS
Closed
10/29/2013 2013-7796
09/30/2013
Isabella Biedenharn
FDA/OMPT/CDER/ORP/DIDP/
Status / Status Date
09/30/2013
10/29/2013 2013-7797
09/30/2013
KARL STORZ ENDOSCOPY AMERICA INC
FDA/OMPT/CDRH/OCER/DFOI/
K124031
Pending Action 09/30/2013
10/29/2013 2013-7798
09/30/2013
Goodell DeVries Leech & Dann LLP
FDA/OC/OES/DDM/
10/29/2013 2013-7799
09/30/2013
MORGAN, LEWIS & BOCKIUS
10/29/2013 2013-7800
09/30/2013
Goodell DeVries Leech & Dann LLP
09/30/2013
Janus Capital Group Attn: Rachelle Lyon
2013-7802
09/30/2013
09/30/2013
09/30/2013
FDA OTC DRUG ADVISORY COMMITTEE - MTG MINUTES WITH DR ERIC PAUL BASS 01/01/1990 - 12/31/1996
Pending Action
SENSIENT TECHNOLOGIES CORP - 483, RESPONSE 09/01/2011 - 09/27/2013
Pending Action
METAGENICS - RESPONSE TO WARNING LETTERS
Pending Action
K131345
Pending Action
FDA/OC/OES/DDM/
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
10/29/2013 2013-7803
Pending Action
Pending Action
10/29/2013 VRP Manufacturing, LLC
FDA COMMITTEE MEETING FOR PEDIATRIC IBUPROFEN - MEETING MINUTES 01/01/1994 - 06/20/1995
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ ALBEMARLE CORPORATION, SOUTH HAVEN, MI - EIR SUMMARY (01/01/2012 01/31/2012)
10/29/2013 2013-7801
09/30/2013
09/30/2013
09/30/2013
09/30/2013
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ ALBERMARLE CORPORATION, SOUTH HAVEN, MI - EIR SUMMARY 02/12/2013 02/15/2013
Pending Action
MORGAN, LEWIS & BOCKIUS
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ ALBEMARLE CORPORATION, SOUTH HAVEN, MI - EIR 02/12/2013 - 02/15/2013
Duplicate Request
MORGAN, LEWIS & BOCKIUS
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ ALBERMARLE CORPORATION, SOUTH HAVEN, MI - EIR 01/01/2012 - 01/31/2012
Duplicate Request
The Windward Company
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
09/30/2013
10/29/2013 2013-7807
09/30/2013
09/30/2013
MORGAN, LEWIS & BOCKIUS
10/29/2013 2013-7806
09/30/2013
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7805
09/30/2013
Neely, Heather
10/29/2013 2013-7804
09/30/2013
10/29/2013
Page 2 of 19
WIL RESEARCH LABORATORIES, ASHLAND, OH - EIR 03/06/2013 03/21/2013
09/30/2013
09/30/2013
09/30/2013 Pending Action 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
2013-7808
09/30/2013
The Economic Times, The Times of India
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ OHM LABS, US - 483 06/29/2012 09/01/2013 FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
10/29/2013
Subject
Page 3 of 19
Status / Status Date Pending Action 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
DCB/
Page 4 of 19
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7809
09/30/2013
N/A
ORA/OCI/
INDIVIDUAL RECS
10/29/2013
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
Page 5 of 19
Status / Status Date Pending Action 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
DCB/ 2013-7810
09/30/2013
Taradash Law Office
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7811
09/30/2013
Taradash Law Office
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7812
09/30/2013
Matthew Hodgson
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
10/29/2013 2013-7813
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
10/29/2013 2013-7814
09/30/2013
WASHINGTON INFORMATION SOURCE
10/29/2013 2013-7815
09/30/2013
WASHINGTON INFORMATION SOURCE
10/29/2013 2013-7816
09/30/2013
WASHINGTON INFORMATION SOURCE
09/30/2013
09/30/2013
09/30/2013
09/30/2013
09/30/2013
09/30/2013 10/29/2013
JANET K TILISCH MD, FARGO, ND - EIR, CO RESP, CORR 4/13
Acknowledgement Letter
ZEPPESSIS REPROCESSING LLC, GARDEN CITY, ID - EIR, CO RESP, CORR 4/13
Acknowledgement Letter
AUTOMATED OPHTHALMIC, COLUMBIA, MD - EIR, CO RESP, CORR 2/13 TO 3/13
Acknowledgement Letter
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
WASHINGTON INFORMATION SOURCE
WASHINGTON INFORMATION SOURCE
09/30/2013
Acknowledgement Letter
FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ BIOMEDIX INC, BLOOMINGTON, IN - EIR, CO RESP, CORR 2/13 TO 3/13
WASHINGTON INFORMATION SOURCE
09/30/2013
LUMIQUICK DIAGNOSTICS INC, SANTA CLARA, CA - EIR, CO RESP, CORR 11/12 FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ TO 12/12
WASHINGTON INFORMATION SOURCE
10/29/2013 2013-7822
Pending Action
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
10/29/2013 2013-7821
C FORDHAM VON REYN, MD - WARNING LETTER FOLLOW UP
09/30/2013
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
10/29/2013 2013-7820
Pending Action
WASHINGTON INFORMATION SOURCE
10/29/2013 2013-7819
ABBOTT PLUMB PUMP - MAUDE REPORTS 10/28/2004 - 09/28/2013
09/30/2013
Acknowledgement Letter
10/29/2013 2013-7818
Pending Action
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ PETER SCHIFFENT ENTERPRISES, COOKEVILLE, TN - EIR, CO RESP, CORR 3/13 TO 4/113
10/29/2013 2013-7817
HOSPIRA PLUMB PUMP - MAUDE REPORTS 09/28/2004 - 09/28/2013
ACELL INC, COLUMBIA, MD - EIR, CO RESP, CORR 11/12 TO 12/12
09/30/2013
09/30/2013
09/30/2013
09/30/2013 Closed Denial 09/30/2013 Acknowledgement Letter 09/30/2013
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ ELECTROMEDICAL PRODUCTS INTERNATIONAL INC, MINERAL WELLS, TX - EIR, CO RESP, CORR 1/13 TO 2/13
Acknowledgement Letter
FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ SOVEREIGN PHARMS, FORT WORTH, TX - EIR, CO RESP, CORR 1/12 TO 2/12
Acknowledgement Letter
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ CISPHARMA, CRANBURY, NJ - EIR, CO RESP CORR 3/12 TO 4/12
Acknowledgement Letter
Page 6 of 19
09/30/2013
09/30/2013
09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7823
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
TRANSONIC SYSTEMS INC, ITHACA, NY - EIR, CO RESP, CORR 2/13 TO 3/13
10/29/2013
Page 7 of 19
Status / Status Date Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
DCB/
Page 8 of 19
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7824
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
CONAIR CORP, STAMFORD, CT - EIR, CO RESP, CORR 5/13
10/29/2013
Page 9 of 19
Status / Status Date Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
CB/
Page 10 of 19
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7825
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-
SPINE FRONTIER, BEVERLY, MA - EIR, CO RESP, CORR 5/12 TO 7/12
10/29/2013
Page 11 of 19
Status / Status Date Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Subject
Action Offices
Status / Status Date
CB/ 2013-7826
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/
10/29/2013 2013-7827
09/30/2013
WASHINGTON INFORMATION SOURCE
10/29/2013 2013-7828
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ HAIR LABS INC, NASHVILLE, TN - EIR, CO RESP, CORR 4/13 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
10/29/2013 2013-7829
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
10/29/2013 2013-7830
09/30/2013
WASHINGTON INFORMATION SOURCE
10/29/2013
2013-7831
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
10/29/2013 2013-7833
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/
10/29/2013 2013-7834
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/
10/29/2013
Page 12 of 19
Acknowledgement Letter 09/30/2013 Duplicate Request 10/04/2013
SCM TRUE AIR TECHNOLOGIES, LOUISVILLE, KY - 483, CO RESP, WARNING LTR, ETC 5/13
Acknowledgement Letter
BACTERIN INTERNATONAL, BELGRADE, MT - EIR, CO RESP, CORR 7/12
Acknowledgement Letter
09/30/2013
FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ TISSUE BANK INTERNATIONAL / NATIONAL EYE BANK CENTER, MEMPHIS, TN - EIR, CO RESP, CORR 6/11
10/29/2013 2013-7832
STEWART COMPOUNDING PHARMACY, FAYETTEVILLE, NC - EIR, CO RESP, CORR 3/13
09/30/2013 Acknowledgement Letter 09/30/2013
LIFEWATCH SERVICES, ROSEMONT, IL EIR, CO RESP, CORR 8/12 TO 9/12
Acknowledgement Letter
ABBEY COLOR, PHILADELPHIA, PA EIR, CO RESP, CORR 3/12
Acknowledgement Letter
ANSAR GROUP, PHILADELPHIA, PA EIR, CO RESP, CORR 5/12 TO 6/12
Acknowledgement Letter
PARKS MEDICAL ELECTRONICS, ALOHA, OR - EIR, CO RESP, CORR 7/12 TO 8/12
Acknowledgement Letter
09/30/2013
09/30/2013
09/30/2013
09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7835
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-
EDWARDS LIFESCIENCES, DRAPER, UT - EIR, CO RESP, CORR 1/13 TO 2/13
10/29/2013
Page 13 of 19
Status / Status Date Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
CB/ 2013-7836
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/
10/29/2013 2013-7837
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/
10/29/2013 2013-7838
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
10/29/2013 2013-7839
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
10/29/2013 2013-7840
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/
10/29/2013 2013-7841
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OMPT/CDER/ORP/DIDP/
10/29/2013 2013-7842
09/30/2013
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7843
09/30/2013
MEDICAL CHEMICAL CORP
10/29/2013 2013-7844
09/30/2013
FDA/OMPT/CDRH/OCER/DFOI/
09/30/2013
09/30/2013
09/30/2013
09/30/2013
09/30/2013
09/30/2013 10/29/2013
CUSTOM COMPOUDING CENTERS, LOS ALAMITOS, CA - EIR, CO RESP, CORR 11/12 TO 12/12
Acknowledgement Letter
ALPHA MEDICAL INSTRUMENTS, MISSION VIEJO, CA - EIR, CO RESP, CORR 12/12/ TO 1/13
Closed Denial
WOCKHARDT LTD, AURANGABAD, INDIA - EIR, CO RESP, CORR 3/13
Acknowledgement Letter
ADVANCED STERILIZATION PRODUTS INC - CIDEX OPA SOL K002401
Acknowledgement Letter
MINNTECH CORP - RAPICIDE OPA-28 K120306
Closed
10/18/2013
09/30/2013
10/21/2013
09/30/2013
09/30/2013
10/01/2013
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/
SERIM RESEARCH CORP - CIDEX OPA SOL TEST STRIPS K992341
Acknowledgement Letter
ADVANCED STERILIZATION PRODUCTS INC - CIDEX OPA CONCENTRATE K032959
Closed
ALBERT BROWNE LTD - BROWNE CIDEX OPA INDICATOR K991709
Acknowledgement Letter
ADVANCED STERILIZATION PRODUCTS INC - CIDEX OPA SOL K991487
Acknowledgement Letter
ADVANCED STERILIZATION PRODUCTS INC - CIDEX OPA SOL K001381
Acknowledgement Letter
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/
MEDICAL CHEMICAL CORP
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7850
Closed Denial
Acknowledgement Letter
10/29/2013 2013-7849
INNOVACYN INC, RIALTO, CA - EIR, CO RESP, CORR 11/11 TO 12/11
09/30/2013
SERIM RESEARCH CORP - RAPICIDE OPA-28 TEST STRIPS K120652
10/29/2013 2013-7848
Acknowledgement Letter
FDA/OMPT/CDRH/OCER/DFOI/
10/29/2013 2013-7847
ALMA LASERS INC, BUFFALO, GROVE, IL - EIR, CO RESP, CORR 1/13
09/30/2013
MEDICAL CHEMICAL CORP
10/29/2013 2013-7846
Acknowledgement Letter
FDA/OC/OES/DFOI/
10/29/2013 2013-7845
LIFESERVE BLOOD CENTER, DES MOINES, IA - EIR, CO RESP, CORR 6/13
LAW OFFICES OF RICHARD N SHAPIRO
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ TRIDENT - PSL ACETABULAR SHELLS; PSL HA SOLID BACK - PMA, 510K FDA/OMPT/CDRH/OCER/DFOI/
Page 14 of 19
09/30/2013
09/30/2013
10/01/2013
09/30/2013
09/30/2013
09/30/2013 Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
2013-7851
09/30/2013
LAW OFFICES OF RICHARD N SHAPIRO
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ TRIDENT - ACETABULAR SHELLS K001448 FDA/OMPT/CDRH/OCER/DFOI/
Acknowledgement Letter
FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ HOWMEDICA OSTEONICS CORP ABC/TRIDENT SYSTEMS PMA FDA/OMPT/CDRH/OCER/DFOI/
Acknowledgement Letter
10/29/2013 2013-7852
09/30/2013
LAW OFFICES OF RICHARD N SHAPIRO
10/29/2013 2013-7853
09/30/2013
HEMOCUE INC
10/29/2013
Subject
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/
Status / Status Date 09/30/2013
09/30/2013
ROCHE - IMFORM; K121679; ABBOT FREE STYLE PRECISONS PRO K130094; NOVA - STATATRIP K063821
Partial Response
Acknowledgement Letter
10/01/2013
FDA/OC/OES/DFOI/ 2013-7854
09/30/2013
Center for Regulatory Services, Inc.
FDA/OC/OES/DDM/
DKT 1995-S-0039 - 75 DAY NOTICE
ZETETIC
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
ETHICON - US/NM SUTURE ABSORBABLE & NON ABSORBABLE ENTRY #AV3-0040036-1
Acknowledgement Letter
09/30/2013
10/29/2013 2013-7855
09/30/2013 10/29/2013
2013-7856
09/30/2013
ZETETIC
FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/
ETHICON - ETHIBOND EXCEL SUTURE ENTRY NO UPS-8151908-7
Acknowledgement Letter
ZETETIC
FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/
ETHICON - NON ABSORBABLE SUTURES & ABSORBABLE SUTURES ENTRY NO AV3-0039869-0
Acknowledgement Letter
10/29/2013 2013-7857
09/30/2013
09/30/2013
10/29/2013
Page 15 of 19
09/30/2013
09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7858
09/30/2013
LINCARE INC
FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-
CLARK RESPIRATORY & MEDICAL SUPPLY, HIGHLAND, NY - 483, EIR, WARNING LTR 1/98 TO PRESENT
10/29/2013
Page 16 of 19
Status / Status Date Acknowledgement Letter 09/30/2013
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
Status / Status Date
DCB/ 2013-7859
09/30/2013
LINCARE INC
FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/
10/29/2013 2013-7860
09/30/2013
LACHMAN CONSULTANT SERVICES INC
FDA/OMPT/CDER/ORP/DIDP/
OXY MED INC, MIDDLETON, OH - 483, EIR, WARNING LTR 1/98 TO PRESENT
Acknowledgement Letter
USV LIMITED, MUMBAI, INDIA - 483 7/6/13
Closed 10/21/2013
10/29/2013 2013-7861
09/30/2013
Walt Disney Studios
OSTEOGENICS BIOMEDICAL - DATE OF SUBMISSION, FEI
Pending Action
DR REDDYS LABS - AZACITIDINE ANDA 01-537 APRVL
Acknowledgement Letter
SUN PHARMA GLOBAL - DOXORUBICIN HCL (LIPOSOMAL) ANDA 03-263 SBA
Acknowledgement Letter
FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/
ENTRY NO MU8-0029278-9
Acknowledgement Letter
NEMEL, RANDY
FDA/OMPT/CDER/ORP/DIDP/
GABAPENTIN - AER
JH BARR & ASSOCIATES LLC
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 8/26-30/13
JH BARR & ASSOCIATES LLC
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 9/2-6/13
JH BARR & ASSOCIATES LLC
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
FDA/OMPT/CBER/OCOD/DDOM/ALFB/
10/29/2013 2013-7862
09/30/2013
JONES DAY
FDA/OMPT/CDER/ORP/DIDP/
10/29/2013 2013-7863
09/30/2013
DR REDDY'S LABORATORIES INC
FDA/OMPT/CDER/ORP/DIDP/
10/29/2013 2013-7864
09/30/2013
FLEGENHEIMER INTERNATIONAL INC
09/30/2013
09/30/2013
09/30/2013
09/30/2013
09/30/2013
JH BARR & ASSOCIATES LLC
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
CanReg, Inc.
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 8/26-30/13
09/30/2013
CanReg, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
09/30/2013
CanReg, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
CanReg, Inc.
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 9/2-6/13
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
Closed
Closed
Closed 09/30/2013
10/29/2013 2013-7875
Closed
09/30/2013
10/29/2013 2013-7874
Closed
09/30/2013
10/29/2013 2013-7873
Closed
09/30/2013
10/29/2013 2013-7872
Closed
09/30/2013
10/29/2013 2013-7871
Closed
09/30/2013
10/29/2013 2013-7870
Closed
09/30/2013
10/29/2013 2013-7869
Closed
09/30/2013
10/29/2013 2013-7868
09/30/2013
09/30/2013
10/29/2013 2013-7867
09/30/2013
10/21/2013
10/29/2013 2013-7866
09/30/2013
09/30/2013
10/29/2013 2013-7865
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
Closed 09/30/2013
10/29/2013
Page 17 of 19
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7876
09/30/2013
DOMINION GROUP INC
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
DOMINION GROUP INC
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
09/30/2013
Center for Regulatory Services, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
Center for Regulatory Services, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
09/30/2013
FOI Services, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
09/30/2013
FOI Services, Inc.
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
FOI Services, Inc.
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 8/26-30/13
09/30/2013
09/30/2013
FOI Services, Inc.
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 9/2-6/13
09/30/2013
WOLTERS KLUWER LAW & BUSINESS
FDA/OC/OES/DFOI/
DAILY LOG 9/2-6/13
09/30/2013
WOLTERS KLUWER LAW & BUSINESS
FDA/OC/OES/DFOI/
DAILY LOG 8/26-30/13
09/30/2013
WOLTERS KLUWER LAW & BUSINESS
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 8/26-30/13
09/30/2013
WOLTERS KLUWER LAW & BUSINESS
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 9/2-6/13
09/30/2013
FDA REVIEW/FDA WEBVIEW
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 8/26-30/13
09/30/2013
FDA REVIEW/FDA WEBVIEW
FDA/OC/OES/DFOI/
DAILY CLOSED LOG 9/2-6/13
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
2013-2471, 3021, 3532
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
2013-721, 930, 737
09/30/2013
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
2013-142, 8434, 8069
WASHINGTON INFORMATION SOURCE
FDA/OC/OES/DFOI/
2012-7797, 2191, 2975
09/30/2013
Closed 09/30/2013
10/29/2013 2013-7893
Closed 09/30/2013
10/29/2013 2013-7892
Closed 09/30/2013
10/29/2013 2013-7891
Closed 09/30/2013
10/29/2013 2013-7890
Closed 09/30/2013
10/29/2013 2013-7889
Closed 09/30/2013
10/29/2013 2013-7888
Closed 09/30/2013
10/29/2013 2013-7887
Closed 09/30/2013
10/29/2013 2013-7886
Closed 09/30/2013
10/29/2013 2013-7885
Closed 09/30/2013
10/29/2013 2013-7884
Closed 09/30/2013
10/29/2013 2013-7883
Closed 09/30/2013
10/29/2013 2013-7882
Closed 09/30/2013
10/29/2013 2013-7881
Closed 09/30/2013
10/29/2013 2013-7880
Closed 09/30/2013
10/29/2013 2013-7879
Closed 09/30/2013
10/29/2013 2013-7878
Closed 09/30/2013
10/29/2013 2013-7877
Status / Status Date
Closed 09/30/2013
10/29/2013 Page 18 of 19
October 22, 2013 11:41 AM
Query Result Report Records: 100 Control #
Recd Date / Due Date
Requester
Action Offices
Subject
2013-7894
09/30/2013
DEERFIELD INSTITUTE
FDA/OC/OES/DFOI/
BIOGEN IDEC - 483 3/15/13
Status / Status Date Closed 09/30/2013
10/29/2013
Page 19 of 19
October 22, 2013 11:41 AM
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