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Frequently Requested
ORA Documents and FDA 483s

Last Update: August 3, 2004

Frequently requested ORA documents disclosed pursuant to the Freedom of Information Act (FOIA): (Redacted per 21 CFR Part 20):

  • new iconAmerican 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
  • FDA Freedom of Information Reading Room and
    Warning Letters  

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