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ORA Electronic Reading Room

Last Update: January 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.

  • new 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 Format is Adobe [PDF] (13 pages, 16,797 KB.)
    • Inspectional Observations (483) 8/25 - 9/5/08 Format is Adobe [PDF] (13 pages, 1,642 KB.)
  • Novartis Consumer Health, Lincoln, NE, Establishment Inspection Report (EIR) 9/9 – 9/11/2008 Format is Adobe [PDF] (13 pages, 847 KB.)
  • Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008 Format is Adobe [PDF] (7 pages, 709 KB.)
  • Apotheca, Inc., Woodbine, IA, Inspectional Observations (483), 8/19 – 8/28/2008 Format is Adobe [PDF] (5 pages, 491 KB.)
  • Advanced Medical Optics, Inc., 483 Inspectional Observations, Santa Ana, CA, dated 05/29/2007 - 06/25/2007 Format is Adobe [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 Format is Adobe [PDF] (9 pages, 317 KB)
    • Correspondence, dated June 19, 2008 Format is Adobe [PDF] (3 pages, 210 KB)
    • Correspondence, dated July 10, 2008 Format is Adobe [PDF] (2 pages, 158 KB)
    • Correspondence, dated July 25, 2008 Format is Adobe [PDF] (1 page, 80 KB)
    • Correspondence, dated August 8, 2008 Format is Adobe [PDF] (2 pages, 151 KB)
    • Correspondence, dated August 22, 2008 Format is Adobe [PDF] (2 pages, 114 KB)
    • Correspondence, dated September 5, 2008 Format is Adobe [PDF] (2 pages, 150 KB )
    • Correspondence, dated September 19, 2008 Format is Adobe [PDF] (2 pages, 152 KB)
    • Correspondence, dated October 3, 2008 Format is Adobe [PDF] (2 pages, 100 KB)
    • Correspondence, dated October 24, 2008 Format is Adobe [PDF] (2 pages, 169 KB)
    • Correspondence with Attachment, dated November 24, 2008 Format is Adobe [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], Format is Adobe [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], Format is Adobe [PDF] (7 pages, 235 KB).
  • Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008, [HTML] Format is Adobe [PDF] (3 pages, 438 KB.)
  • United States v. American National Red Cross, Civil Action No. 93-0949 (JGP), 02/06/2008 (JGP) [HTML] Format is Adobe [PDF] (16 pages, 1MB.)
  • MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007, [HTML] Format is Adobe [PDF] (8 pages, 945.54 KB.)
  • Shelhigh, Inc., Union, NJ, May 2, 2007, FDA Requested Recall [HTML] Format is Adobe [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] Format is Adobe[PDF] (15 pages, 662 KB)
    • June 22, 2007, Consent order, [HTML] PDF Logo[PDF] (23 pages, 919KB;)
  • American National Red Cross/Biomedical Services, Washington, D.C., April 4, 2007 Adverse Determination Letter [HTML] PDF Logo[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 Logo[PDF] (19 pages, 286 KB)
  • American National Red Cross/Biomedical Services, Washington, D.C., November 21, 2006, NYPR Adverse Determination Letter [HTML] PDF Logo[PDF] (25 pages, 3.7MB)
  • American National Red Cross/Biomedical Services, Washington, D.C., September 7, 2006, Adverse Determination Letter [HTML] PDF Logo[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 Logo PDF size 1.1 MB]
  • Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006, PDF LogoPDF size 670KB [HTML].
    Sanofi Pasteur, Inc., Warning Letter, dated 06/30/2006, PDF LogoPDF 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 LogoPDF size 238KB, [HTML]
  • Andrx Pharmaceutical, Inc., 483 Inspectional Observations, Fort Lauderdale, FL, dated 03/06/2006 - 04/18/2006; PDF LogoPDF 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: PDF Logo483 PDF size 216KB; PDF LogoEIR PDF size 4121KB
    • dated 02/24/2003 - 03/12/2003: PDF Logo483 PDF size 326KB; PDF LogoEIR PDF size 2181KB
    • dated 03/26/2002 - 04/15/2002: PDF Logo483 PDF size 146KB; PDF LogoEIR PDF size 1366KB
    • dated 06/04/2001 - 06/08/2001: PDF Logo483 PDF size 67KB; PDF LogoEIR 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 LogoPDF size 138KB

  • Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006
    PDF LogoPDF size 49 KB. HTML
  • Boston Scientific, 483 Inspectional Observations, six locations:
    • Watertown MA, dated 03/09/2005 - 04/07/2005
      PDF LogoPDF size 234 KB. HTML

    • Quincy MA, dated 03/28/2005 - 05/20/2005
      PDF LogoPDF size 292 KB. HTML

    • Glens Falls NY, dated 04/12/2005 - 05/06/2005
      PDF LogoPDF size 216 KB. HTML

    • (Scimed) Maple Grove MN, dated 07/22/2005 - 08/25/2005 PDF LogoPDF size 90 KB. HTML

    • Natick MA, dated 07/27/2005 - 08/26/2005
      PDF LogoPDF size 182 KB. HTML

    • Spencer IN, dated 08/25/2005 - 09/12/2005
      PDF LogoPDF size 80 KB. HTML
  • Diamond Pet Food Processors, Gaston, SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006
    PDF LogoPDF 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 LogoPDF size 542 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., June 10, 2005 Modified Adverse Determination Letter [HTML] PDF Logo PDF size 899 KB Attachment [HTML]
  • Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005 PDF Logo PDF size 602 KB, [HTML]
  • American National Red Cross/Biomedical Services, Washington, D.C., May 16, 2005 Adverse Determination Letter [HTML] PDF Logo PDF size 28 KB
    Attachment [HTML] PDF Logo PDF size 275 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., March 28, 2005, Adverse Determination Letter [HTML] PDF Logo 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 LogoPDF size 723 KB
    • FDA 483 Inspectional Observations, dated 06/02-10/2003 [HTML] PDF LogoPDF size 486 KB
    • Establishment Inspection Report (EIR), dated 06/02-10/2003 PDF LogoPDF size 376 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., July 13, 2004 Letter [HTML], PDF LogoPDF size 29 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., April 2, 2004, Adverse Determination Letter[HTML], PDF LogoPDF size 33 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., March 8, 2004, Consent Decree Correspondence [HTML], PDF LogoPDF size 20 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., February 11, 2004, Adverse Determination Letter [HTML], PDF LogoPDF 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 LogoPDF size 660 KB
  • American National Red Cross/Biomedical Services, Washington, D.C., July 22, 2003, Adverse Determination Letter [HTML], PDF LogoPDF size 5.6 MB
  • American National Red Cross/Biomedical Services, Washington, D.C., April 15, 2003, Amended Consent Decree [HTML], PDF LogoPart1 PDF size 3.6 MB PDF LogoPart2 PDF size 12.8 MB
  • American National Red Cross/Biomedical Services, Arlington, Virginia, April 14, 2003, Consent Decree Letter [HTML], PDF LogoPDF size 327 KB
  • Cryolife, Connie J. Jones, Kennesaw, GA, 30144,  FDA Inspectional Observations, dated 2/14/2003, PDF LogoPDF size 3198 KB,   [HTML]
  • University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations PDF LogoPDF size 30 KB,   [HTML]
  • American National Red Cross/Biomedical Services, Arlington, Virginia , 04/22/2002 to 12/20/2002 FDA Inspectional Observations PDF LogoPDF size 1845 KB,   [HTML]
  • CryoLife, Inc., Kennesaw, GA, August 13, 2002 Order for Retention, Recall, and/or Destruction    [PDF LogoPDF] 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 LogoPDF] 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 LogoPDF] 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 LogoPDF
    FDA 483, Insp.Observations: (Las Piedras) 06/05/2001, 1.4 MB PDF LogoPDF
    FDA 483, Insp.Observations; (Manati) 02/16/2001, 1.0 MB PDF LogoPDF
    FDA 483, Insp.Observations; (Las Piedras) 02/16/2001, 2.3 MB PDF LogoPDF
    FDA 483, Insp.Observations; (Manati) 12/14/2000, 1.1 MB PDF LogoPDF
    FDA 483, Insp.Observations; (Manati)(03/28/2000), 1.3 MB PDF LogoPDF
  • 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 LogoPDF; 
    Warning Letter, dated 03/02/2001; 384 KB PDF LogoPDF
    Response (interim) dated 03/08/2001; 227 KB PDF LogoPDF
    Response to FDA dated 03/08/2001; 9.2 MB PDF LogoPDF
  • Bioport Corporation, Lansing, MI
    FDA 483, dated 10/10-26/2000, (18 pages) 3.3MB PDF LogoPDF
  • New York Blood Center, Inc., New York, NY
    Establishment Inspection Report (EIR) (inspection 10/29/1996 to 12/20/1996)  5MB PDF LogoPDF
  • Time Cap Labs, Inc., Farmingdale, NY
    FDA 483, (inspection 03/26 - 05/05/1998) 1.6 MB PDF LogoPDF
  • Forest/Inwood Laboratories, Inc., Farmingdale, NY
    FDA 483, dated 10/23/1998, 394KB PDF LogoPDF

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