| ALBA Bioscience (formerly Diagnostics Scotland), SNBTS |
02/03/2009 |
Center for Biologics Evaluation and Research |
CGMP Deviations/Manufacture of
Blood Grouping Reagents (BCR)
|
No |
|
| ALK-Abello Inc. |
03/16/2000 |
Center for Biologics Evaluation and Research |
Allergenic Extracts/Good
Manufacturing
Practices/Biologicals
Standards Products
|
No |
|
| ALK-Abello, Inc. |
09/06/2006 |
Center for Biologics Evaluation and Research |
Promotional Claims False &
Misleading/Misbranded
|
No |
|
| Abbott Laboratories |
03/19/1999 |
Center for Biologics Evaluation and Research |
Dear Abbokinase Customer
Letter/Omission False
Misleading Statements
|
No |
|
| Abbott Laboratories Inc. |
07/06/2000 |
Center for Biologics Evaluation and Research |
GMPfor Finished
Pharmaceuticals/Biological
Establishment
Licensing/Sterility
|
No |
|
| Adkinson N. Franklin Jr. M.D. |
04/19/2000 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Allergan Inc. |
10/06/1998 |
Center for Biologics Evaluation and Research |
Deviation from Good
Manufacturing Practice
|
No |
|
| Allergan, Inc. |
06/23/2003 |
Center for Biologics Evaluation and Research |
BOTOX/False & Misleading
Material/Misbranded
|
No |
|
| Allergan, Inc. |
08/22/2001 |
Center for Biologics Evaluation and Research |
Violative Promotion
Advertising/Lacking Fair
Balance/Misleading
|
No |
|
| Allergologisk Laboratorium A/S |
11/17/1997 |
Center for Biologics Evaluation and Research |
Drug Products/Testing |
No |
|
| Allergy Laboratories Inc. |
08/14/1998 |
Center for Biologics Evaluation and Research |
Failure to Observe Code of
Federal Regulations
|
No |
|
| Allergy Laboratories of Ohio Inc. |
01/23/2001 |
Center for Biologics Evaluation and Research |
GMP for Finished
Pharmaceuticals/Biologicals/Re
porting of Errors/Changes to
Approved Application
|
No |
|
| Allermed Laboratories Inc. |
06/03/1998 |
Center for Biologics Evaluation and Research |
Deviation from Good
Manufacturing Practice
|
No |
|
| Amsterdam, Daniel, Ph.D. |
11/17/2004 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Andrews David W. M.D. |
07/19/2000 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Associates of Cape Cod Inc. |
11/17/2000 |
Center for Biologics Evaluation and Research |
Quality System Regulation |
No |
|
| Associates of Cape Cod Inc. |
12/22/1999 |
Center for Biologics Evaluation and Research |
Quality System
Regulation/Biologics Listing
etc.
|
No |
|
| Avax Technologies, Inc. |
10/30/2001 |
Center for Biologics Evaluation and Research |
Sponsor/Monitor/Contract
Research Organization
|
No |
|
| Aventis Behring L.L.C. |
01/22/2001 |
Center for Biologics Evaluation and Research |
Good Manufactuting Practices
for Finished
Pharmaceuticals/Biologicals
Physical Establishment Etc.
|
No |
|
| Aventis Behring, L.L.C. |
10/12/2004 |
Center for Biologics Evaluation and Research |
Promotional Claims/False &
Misleading
|
No |
|
| Baltimore City Health Department |
12/15/2005 |
Center for Biologics Evaluation and Research |
Institutional Review Board |
No |
|
| Batshaw Mark L. M.D. |
11/30/2000 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Baxter Healthcare Corp |
04/14/2009 |
Center for Biologics Evaluation and Research |
Labeling/False & Misleading
Claims/Misbranded
|
No |
|
| Baxter Healthcare Corporation |
05/25/2004 |
Center for Biologics Evaluation and Research |
Promotional Claims/Misbranded |
No |
|
| Baxter Healthcare Corporation |
05/11/2004 |
Center for Biologics Evaluation and Research |
Promotional Claims/Misbranded |
No |
|
| Baxter Healthcare Corporation |
06/05/1997 |
Center for Biologics Evaluation and Research |
Failure to Observe Standard
Operating Procedures
|
No |
|
| Bayer Corporation |
07/24/2001 |
Center for Biologics Evaluation and Research |
Current Good Manufacturing
Practices for Finished
Pharmaceuticals/Adulterated
|
No |
|
| Bayer Corporation |
01/30/1998 |
Center for Biologics Evaluation and Research |
Drug Products |
No |
|
| Bayer Corporation |
01/20/1997 |
Center for Biologics Evaluation and Research |
Biologics |
No |
|
| Bear, Harry D., M.D., Ph.D. |
09/27/2002 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Belleza Integral C.A. |
08/31/2004 |
Center for Biologics Evaluation and Research |
Unapproved New Drug/Lacks New
Drug Application
|
No |
|
| Berger Mitchel S. M.D. |
08/02/2000 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Bilchik, Anton J., M.D., Ph.D. |
08/31/2004 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Bill Gray Medical Corporation |
04/02/2003 |
Center for Biologics Evaluation and Research |
New Drug/Approved Biologics
License Application
|
No |
|
| Bio-Rad Laboratories Inc. |
03/18/1999 |
Center for Biologics Evaluation and Research |
CFR Deviations |
No |
|
| BioReliance Corporation |
01/05/2009 |
Center for Biologics Evaluation and Research |
Good Laboratory Practice (GLP)
Regulations
|
No |
|
| BioWhittaker Inc. |
09/18/1998 |
Center for Biologics Evaluation and Research |
CGMP Deviations |
No |
|
| Biogen Inc. |
03/29/2001 |
Center for Biologics Evaluation and Research |
Labeling/False &
Misleading/Avonex
|
No |
|
| Biologicalmiracle.com |
01/16/2004 |
Center for Biologics Evaluation and Research |
New Drug |
No |
|
| Biopool International Inc. |
03/02/1999 |
Center for Biologics Evaluation and Research |
Biologics laboratory testing
Quality System Regulation
|
No |
|
| Biosera Inc. |
10/17/1997 |
Center for Biologics Evaluation and Research |
Blood Products |
No |
|
| Biotest AG |
01/22/1999 |
Center for Biologics Evaluation and Research |
CFR Deviations |
No |
|
| Buchman Alan L. M.D. |
11/30/2000 |
Center for Biologics Evaluation and Research |
Clinical Investigator |
No |
|
| Calypte Biomedical Corporation |
05/03/1999 |
Center for Biologics Evaluation and Research |
Quality System Regulation |
No |
|
| Calypte Biomedical Corporation |
11/13/1998 |
Center for Biologics Evaluation and Research |
Deviations from Code of
Federal Regulations
|
No |
|
| Cambridge Biotech Corporation |
03/09/1998 |
Center for Biologics Evaluation and Research |
Deviation from Good
Manufacturing Practice
|
No |
|
| Cancer Therapeutics, Inc. |
11/18/2003 |
Center for Biologics Evaluation and Research |
New Drug |
No |
|
| Cangene Corporation |
02/08/2001 |
Center for Biologics Evaluation and Research |
GMP for Finished
Products/Biologics/Establishme
nt Licensing
|
No |
|
| Centeon Pharma GmbH |
12/08/1997 |
Center for Biologics Evaluation and Research |
Biologics |
No |
|
| Centocor Inc. |
07/10/1998 |
Center for Biologics Evaluation and Research |
Deviation from applicable
Standard Operating Procedures
|
No |
|
