ORA Electronic Reading Room
Last Update: April 14, 2009
The ORA Electronic Reading Room displays copies of ORA records.
We are making these records publicly available either (1) proactively
at our discretion or (2) because they are "frequently requested" per
the Electronic Freedom of Information Act Amendments of 1996. Some
records may be redacted to remove non-public information (see 21
CFR Part 20). For other ORA documents, please visit the ORA
home page and the FDA Warning
Letter page ; for other FDA documents, please visit the FDA
Freedom of Information (FOI) page.
-
Peanut Corporation of America (PCA), Blakely, GA:
- Consumer Complaints:
- Complaint No. 74893 (2-03-2009) [PDF]
(3 pages, 119 KB.)
- Complaint No. 74073 (1-28-2009) [PDF]
(3 pages, 138 KB.)
- Complaint No. 73725 (1-26-2009) [PDF]
(3 pages, 143 KB.)
- Complaint No. 73596 (1-24-2009) [PDF]
(3 pages, 131 KB.)
- Complaint No. 73576 (1-23-2009) [PDF]
(3 pages, 129 KB.)
- Complaint No. 73192 (1-22-2009) [PDF]
(3 pages, 119 KB.)
-
AMAG Pharmaceuticals Inc., Cambridge, MA
- FDA Form 483 (Inspectional Observations), 9/18 - 10/14/08
[PDF (8
pages, 768 KB)
- Medtronic
Inc.
- Correspondence between Medtronic and FDA regarding Sprint Fidelis
Leads Recall FDA to Medtronic, 11/1/07 [PDF (2
pages, 130 KB)
- Medtronic to FDA, 10/27/08 [PDF (7
pages, 289 KB)
- Medtronic Inc. Cardiac Rhythm Disease Management, Mounds View, MN,
Establishment Inspection Report (EIR), 10/18 – 12/21/07 [PDF (28
pages, 346 KB)
- Medtronic Puerto Rico Operations Co., Villalba, PR, Establishment
Inspection Report (EIR), 10/29 – 12/14/07 [PDF (22
pages, 1296 KB)
- Medtronic Puerto Rico Operations Co., Villalba, PR, Establishment
Inspection Report (EIR), 10/1-10/03 [PDF (6
pages, 337 KB)
- Medtronic Puerto Rico Operations Co., Villalba, PR, Establishment
Inspection Report (EIR), 3/2-9/06 [PDF (7
pages, 317 KB)
- Sanfilippo
John B & Son, Inc., Bainbridge, GA:
- Establishment Inspection Report (EIR), 6/27 - 7/10/07 [PDF (4
pages, 181 KB).
- ConAgra
Grocery Products, Sylvester, GA:
- Establishment Inspection Report (EIR), 4/21/04
[PDF (1
page, 32 KB).
- Establishment Inspection Report (EIR), 5/6/98
[PDF (5
page, 87 KB).
- Memo, NYK-DO to ATL-DO, 7/18/00
[PDF (1
page, 36 KB).
- FDA Endorsement Summary, 3/30/07
[PDF (1
page, 25 KB).
- Establishment Inspection Report (EIR), 2/14 - 3/2/07
[PDF (28
pages, 2.91 MB).
- Establishment Inspection Report (EIR), 8/20 - 23/07
[PDF (20
pages, 2.1 MB).
- FDA Form 483 (Inspectional Observations), 8/23/07
[PDF (2
pages, 38 KB).
- MARCS Recall Details, 2/19/08
[PDF (14
pages, 850 KB).
- Establishment Inspection Report (EIR), 8/3/00
[PDF (2
pages, 136 KB).
- Establishment Inspection Report (EIR), 2/23 - 24/05
[PDF (13
pages, 1.21 MB).
- Establishment Inspection Report (EIR), 7/25/00
[PDF (3
pages, 157 KB).
- Memo, ATL-DO to Tifton, GA RP, 2/23/04
[PDF (3
pages, 244 KB).
- FDA Endorsement Summary, 8/4/00
[PDF (1
pages, 89 KB).
- KV Pharmaceutical, Saint Louis, MO, 12/15 — 2/2/09:
- FDA Form 483 (Inspectional Observations) [PDF]
(37 pages, 10 MB).
- American Blanching Company, Fitzgerald, GA 4/8/08:
- Establishment Inspection Report (EIR) [PDF]
(5 pages, 259 KB).
- Peanut Corporation of America (PCA), Plainview TX:
- FDA Form 483 (Inspectional Observations) 2/4/09 – 2/26/09 [PDF]
(7 pages, 4,040 KB).
- Peanut
Corporation of America (PCA), Blakely, GA:
- January 2009 Inspection
- Amended FDA Form 483 (Inspectional Observations) Jan 9
- Feb 5, 2009 [PDF]
(8 pages, 742 KB.)
- FDA Form 483 (Inspectional Observations) Jan 9 - 27,
2009 [PDF]
(6 pages, 441 KB.)
- June 2008 Inspection
- FDA Endorsement Summary, 6/17/08 [PDF]
(5 pages, 69 KB.)
- Establishment Inspection Report (EIR), 6/17/08 [PDF]
(5 pages, 252 KB.)
- August - September 2007 Inspection
- FDA Endorsement Summary, 8/23-9/4/07 [PDF]
(5 pages, 72 KB.)
- Establishment Inspection Report (EIR), 8/23-9/4/07 [PDF]
(3 pages, 147 KB.)
- November 2001 Inspection
- FDA Form 483 (Inspectional Observations) 11/15/01 [PDF]
(1 page, 59 KB.)
- Establishment Inspection Report (EIR), 11/15/01 [PDF]
(18 pages, 981 KB.)
- Marietta
Corporation, Cortland, NY, 8/18 – 19/08, Establishment Inspection
Report (EIR) [PDF]
(9 pages, 428 KB.)
- Wyeth Pharmaceutical, Pearl River, NY 8/27-10/8/08, 483 Inspectional
Observations, Establishment Inspection Report (EIR):
- Inspectional Observations (483), 10/08/08 [PDF]
(1 pages, 186 KB.)
- Establishment Inspection Report (EIR), 8/27-10/8/08
[PDF]
(51 pages, 7,122 KB.)
- NBTY,
Inc. Boca Raton, FL 8/25-9/5/08, 483 Inspectional Observations,
Establishment Inspection Report (EIR):
- Establishment Inspection Report (EIR) 8/25 - 9/5/08 [PDF]
(13 pages, 16,797 KB.)
- Inspectional Observations (483) 8/25 - 9/5/08 [PDF]
(13 pages, 1,642 KB.)
- Novartis Consumer Health, Lincoln, NE, Establishment Inspection
Report (EIR) 9/9 – 9/11/2008 [PDF] (13 pages, 847 KB.)
- Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008 [PDF] (7 pages, 709 KB.)
- Apotheca, Inc., Woodbine, IA, Inspectional Observations (483), 8/19 – 8/28/2008 [PDF] (5 pages, 491 KB.)
- Advanced Medical Optics, Inc., 483 Inspectional Observations, Santa Ana, CA, dated 05/29/2007 - 06/25/2007 [PDF] (12 pages, 563 KB.)
- Caraco Pharmaceutical Laboratories, Inc., 483 Inspectional Observations, Detroit, MI, inspection 05/01/2008 - 06/11/2008, and Related Correspondence from Firm:
- FDA 483, dated June 11, 2008 [PDF] (9 pages, 317 KB)
- Correspondence, dated June 19, 2008 [PDF] (3 pages, 210 KB)
- Correspondence, dated July 10, 2008 [PDF] (2 pages, 158 KB)
- Correspondence, dated July 25, 2008 [PDF] (1 page, 80 KB)
- Correspondence, dated August 8, 2008 [PDF] (2 pages, 151 KB)
- Correspondence, dated August 22, 2008 [PDF] (2 pages, 114 KB)
- Correspondence, dated September 5, 2008 [PDF] (2 pages, 150 KB )
- Correspondence, dated September 19, 2008 [PDF] (2 pages, 152 KB)
- Correspondence, dated October 3, 2008 [PDF] (2 pages, 100 KB)
- Correspondence, dated October 24, 2008 [PDF] (2 pages, 169 KB)
- Correspondence with Attachment, dated November 24, 2008 [PDF] (26 pages, 1725 KB)
- The Enforcement Story describes examples of noncompliance by regulated
industry. It does not contain all enforcement actions undertaken
by FDA, but a sampling in summary form. The items chosen convey the
significance of the violation and/or court decision(s). The Enforcement
Story presents actual FDA enforcement actions that impact on the
development, manufacture, distribution and marketing of foods, drugs,
biologics, cosmetics and medical devices.
- FDA
issued an notice of default letter, dated
June 20, 2008 to Dr. Amile A. Korangy, M.D. and the Korangy Radiology
Associates. The letter was sent via FAX, First Class Mail and Certified
Mail, and included an attachment (the Agreement document). [HTML], [PDF]
(2 pages, 75 KB).
- FDA issued an adverse determination letter, dated June 3, 2008 to the American National Red Cross. The letter was sent via FAX and Certified Mail. [HTML], [PDF] (7 pages, 235 KB).
- Changzhou
SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional
Observations, 02/26/2008, [HTML] [PDF]
(3 pages, 438 KB.)
- United States v. American National Red Cross, Civil Action No.
93-0949 (JGP), 02/06/2008 (JGP) [HTML] [PDF]
(16 pages, 1MB.)
- MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007, [HTML] [PDF] (8 pages, 945.54 KB.)
- Shelhigh, Inc., Union, NJ,
May 2, 2007, FDA Requested Recall [HTML] [PDF]
(2 pages, 23KB)
NOTE: The Center for Devices has posted a Q&A at http://www.fda.gov/cdrh/news/shelhighrecall.html
* See U.S. District Court for the District of New Jersey documents:
- April 16, 2007, Complaint for forfeiture, [HTML] [PDF]
(15 pages, 662 KB)
- June 22, 2007, Consent order, [HTML] [PDF] (23 pages, 919KB;)
- American National Red Cross/Biomedical Services, Washington, D.C.,
April 4, 2007 Adverse Determination Letter [HTML] [PDF]
(2 pages, 182 KB)
- American National Red Cross/Biomedical Services, Washington, D.C.,
November 15, 2006, Consent Decree Correspondence (regarding September
7, 2006, Adverse Determination Letter, paragraph X) [HTML] [PDF]
(19 pages, 286 KB)
- American National Red Cross/Biomedical Services, Washington,
D.C., November 21, 2006, NYPR Adverse Determination Letter [HTML] [PDF]
(25 pages, 3.7MB)
- American National Red Cross/Biomedical Services, Washington, D.C.,
September 7, 2006, Adverse Determination Letter [HTML] [PDF]
(18 pages, 3.9MB) Note: Related November 15th Correspondence is
also posted.
- American National Red Cross/Biomedical Services, Washington,
D.C., July 27, 2006 Adverse Determination Letter [HTML] PDF size 1.1 MB]
- Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater,
PA, dated 04/18/2006 - 04/28/2006, PDF size 670KB [HTML].
Sanofi Pasteur, Inc., Warning Letter, dated 06/30/2006, PDF size 378KB [HTML].
NOTE: The Center for Biologics Evaluation & Research has posted
a Q & A at http://www.fda.gov/cber/faq/sanofiqa.htm.
- Bausch & Lomb, Inc., 483 Inspectional Observations, Greenville,
SC, dated 03/22/2006 - 05/15/2006, Manufacturer and Repackager/Relabeler
establishment types, PDF size 238KB, [HTML]
- Andrx Pharmaceutical, Inc., 483 Inspectional Observations, Fort
Lauderdale, FL, dated 03/06/2006 - 04/18/2006; PDF size 388KB, [HTML]
- Utah Medical Products, Inc. (UTMD), Salt Lake City, Utah - 483
Inspectional Observations (483) and Establishment Inspection Reports
(EIR) for inspections in 2001-2004*.
For assistance in accessing non-text files, please contact the FDA
Office of Enforcement, Patricia Maroney-Benassi, (240) 632-6819.
- dated 02/02/2004 - 03/03/2004: 483
PDF size 216KB; EIR
PDF size 4121KB
- dated 02/24/2003 - 03/12/2003: 483
PDF size 326KB; EIR
PDF size 2181KB
- dated 03/26/2002 - 04/15/2002: 483
PDF size 146KB; EIR
PDF size 1366KB
- dated 06/04/2001 - 06/08/2001: 483
PDF size 67KB; EIR
PDF size 209KB
* See "United States of America vs. Utah Medical Products,
Inc.," the decision of the U.S. District Court for the District
of Utah, Central Division, October 2005. PDF size 138KB
- Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota,
dated 12/15/2005 - 02/09/2006
PDF size 49 KB. HTML
- Boston Scientific, 483 Inspectional Observations, six locations:
- Watertown MA, dated 03/09/2005 - 04/07/2005
PDF size 234 KB. HTML
- Quincy MA, dated 03/28/2005 - 05/20/2005
PDF size 292 KB. HTML
- Glens Falls NY, dated 04/12/2005 - 05/06/2005
PDF size 216 KB. HTML
- (Scimed) Maple Grove MN, dated 07/22/2005 - 08/25/2005 PDF size 90 KB. HTML
- Natick MA, dated 07/27/2005 - 08/26/2005
PDF size 182 KB. HTML
- Spencer IN, dated 08/25/2005 - 09/12/2005
PDF size 80 KB. HTML
- Diamond Pet Food Processors, Gaston,
SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006
PDF size 110 KB. HTML
- Guidant Corporation, Saint Paul, MN, September 22, 2005
FDA 483 Inspectional Observations, dated 08/22/2005 - 09/01/2005
[HTML]
PDF size 542 KB
- American National Red Cross/Biomedical Services, Washington,
D.C., June 10, 2005 Modified Adverse Determination Letter [HTML] PDF size 899 KB Attachment
[HTML]
- Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional
Observations, dated 05/02-07/01/2005 PDF size 602 KB,
[HTML]
- American National Red Cross/Biomedical Services, Washington,
D.C., May 16, 2005 Adverse Determination Letter [HTML] PDF size 28 KB
Attachment [HTML] PDF size
275 KB
- American National Red Cross/Biomedical Services, Washington,
D.C., March 28, 2005, Adverse Determination Letter [HTML] PDF size 108 KB
- Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK,
November 17, 2004:
- FDA 483 Inspectional Observations, dated 10/10-15/2004 [HTML] PDF size 723 KB
- FDA 483 Inspectional Observations, dated 06/02-10/2003 [HTML] PDF size 486 KB
- Establishment Inspection Report (EIR), dated 06/02-10/2003 PDF size 376 KB
- American National Red Cross/Biomedical Services, Washington, D.C.,
July 13, 2004 Letter [HTML], PDF size 29 KB
- American National Red Cross/Biomedical Services, Washington, D.C.,
April 2, 2004, Adverse Determination Letter[HTML], PDF size 33 KB
- American National Red Cross/Biomedical Services, Washington, D.C.,
March 8, 2004, Consent Decree Correspondence [HTML], PDF size 20 KB
- American National Red Cross/Biomedical Services, Washington, D.C.,
February 11, 2004, Adverse Determination Letter [HTML], PDF size 191 KB
- CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated
10/9, 10, & 14/2003 [PDF]
size 31 KB [HTML]
- American National Red Cross/Biomedical Services, Washington, D.C.,
September 2, 2003, Consent Decree Correspondence [HTML], PDF size 660 KB
- American National Red Cross/Biomedical Services, Washington, D.C.,
July 22, 2003, Adverse Determination Letter [HTML], PDF size 5.6 MB
- American National Red Cross/Biomedical Services, Washington, D.C.,
April 15, 2003, Amended Consent Decree [HTML], Part1
PDF size 3.6 MB Part2 PDF size
12.8 MB
- American National Red Cross/Biomedical Services, Arlington, Virginia,
April 14, 2003, Consent Decree Letter [HTML], PDF size 327 KB
- Cryolife, Connie J. Jones, Kennesaw, GA, 30144, FDA Inspectional
Observations, dated 2/14/2003, PDF size 3198 KB, [HTML]
- University of Illinois @ Urbana - Champaign (Sponsor), Champaign,
Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations PDF size 30 KB, [HTML]
- American National Red Cross/Biomedical Services, Arlington, Virginia
, 04/22/2002 to 12/20/2002 FDA Inspectional Observations PDF size 1845 KB, [HTML]
- CryoLife, Inc., Kennesaw, GA, August 13, 2002 Order for Retention,
Recall, and/or Destruction [PDF] size 279KB [HTML]
- Gary J. Oulette, Executive Director, American Red Cross, Greater
Chesapeake & Potomac Blood Service Region, FDA 483, Insp. Observations
(Baltimore) 06/21/2002 posted 07/15/2002
HTML
- Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB
FDA 483, Insp. Observations (Baltimore) 09/07/2001
[PDF] size 4.62 MB
[HTML]
- Chi Van Dang, M.D., Ph.D./John Hopkins, Bayview Medical Center,
Human Subjects Committee
FDA 483, Insp. Observations (Baltimore) 09/07/2001
[PDF] size 2.59 MB
[HTML]
- Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic,
Baltimore, MD.:
FDA 483, Inspectional
Observations; (Baltimore) 06/28/2001 [HTML]
- Schering-Plough, Manati, Puerto Rico:
FDA 483, Insp.Observations:
(Manati) 06/13/2001, 6.0 MB PDF
FDA 483, Insp.Observations:
(Las Piedras) 06/05/2001, 1.4 MB PDF
FDA 483, Insp.Observations;
(Manati) 02/16/2001, 1.0 MB PDF
FDA 483, Insp.Observations;
(Las Piedras) 02/16/2001, 2.3 MB PDF
FDA 483, Insp.Observations;
(Manati) 12/14/2000, 1.1 MB PDF
FDA 483, Insp.Observations;
(Manati)(03/28/2000), 1.3 MB PDF
- Eli Lilly and Company, Indianapolis, IN. Inspection January
29 to February 23, 2001, Warning Letter, FDA 483 and responses
from firm:
FDA
483, dated 02/23/2001; 4.26 MB PDF;
Warning
Letter, dated 03/02/2001; 384 KB PDF
Response
(interim) dated 03/08/2001; 227 KB PDF
Response
to FDA dated 03/08/2001; 9.2 MB PDF
- Bioport Corporation, Lansing, MI
FDA 483, dated 10/10-26/2000, (18 pages) 3.3MB PDF
- New York Blood Center, Inc., New York, NY
Establishment Inspection Report (EIR) (inspection
10/29/1996 to 12/20/1996) 5MB PDF
- Time Cap Labs, Inc., Farmingdale, NY
FDA 483, (inspection
03/26 - 05/05/1998) 1.6 MB PDF
- Forest/Inwood Laboratories, Inc., Farmingdale, NY
FDA 483,
dated 10/23/1998, 394KB PDF
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