Frequently Requested FDA Documents and FDA 483s
 

1. Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic
2. American Red Cross
3. American National Red Cross/Biomedical Services
    
4. Bioport Corporation
    
5. Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine
6. CryoLife, Inc.
    
7. Eli Lilly and Company
    
8. Evans Vaccine, Ltd., affiliate of Chiron Corp.
    
9. Forest/Inwood Laboratories, Inc.
    
10. New York Blood Center, Inc.
     
11. Schering-Plough
     
12. Time Cap Labs
     
13. University of Illinois @ Urbana

FDA Documents

• Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.:
  FDA 483, Inspectional Observations; (Baltimore) 06/28/2001 [HTML]
   
• American Red Cross, Gary J. Oulette, Executive Director, , Greater Chesapeake & Potomac Blood Service Region, FDA 483, Insp. Observations (Baltimore) 06/21/2002 posted 07/15/2002 HTML
   
• American National Red Cross/Biomedical Services, Arlington, Virginia, April 14, 2003, Consent Decree Letter [HTML], PDF size 327 KB
• American National Red Cross/Biomedical Services, Arlington, Virginia , 04/22/2002 to 12/20/2002 FDA Inspectional Observations PDF size 1845 KB, [HTML]
• 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
• 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
   
• Bioport Corporation, Lansing, MI; FDA 483, dated 10/10-26/2000, (18 pages) 3.3MB PDF
   
• 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]
   
• Cryolife, Connie J. Jones, Kennesaw, GA, 30144,  FDA Inspectional Observations, dated 2/14/2003, PDF size 3198 KB,   [HTML]
• CryoLife, Inc., Kennesaw, GA, August 13, 2002 Order for Retention, Recall, and/or Destruction    [PDF] size 279KB   [HTML]
• CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003 [PDF] size 31 KB [HTML]
   
• 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
   
• Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK, November 17, 2004:
  FDA 483 Inspectional Observations, dated 10/10-15/2004 PDF size 723K KB
  FDA 483 Inspectional Observations, dated 06/02-10/2003 PDF size 486 KB
  Establishment Inspection Report (EIR), dated 06/02-10/2003 PDF size 376 KB
   
• Forest/Inwood Laboratories, Inc., Farmingdale, NY
  FDA 483, dated 10/23/1998, 394KB PDF
   
• New York Blood Center, Inc., New York, NY; Establishment Inspection Report (EIR) (inspection 10/29/1996 to 12/20/1996)  5MB PDF
   
• 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
   
• Time Cap Labs, Inc., Farmingdale, NY; FDA 483, (inspection 03/26 - 05/05/1998) 1.6 MB PDF
   
• University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations PDF size 30 KB, [HTML]