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FDA's Electronic Reading Room - Warning Letters



Warning Letters Search Results


Search Criteria: Office is "Office of Enforcement"
   
Allergy Laboratories of Ohio, Inc.  02/04/2005  Office of Enforcement  Current Good Manufacturing Practice   No   
Amgen, Inc.  05/09/2003  Office of Enforcement  Biologics License/Adulterated  No   
Aventis Pasteur Inc.  04/09/2001  Office of Enforcement  GMP for Mfr Processing Packing Holding Drugs/Biological Products   No   
Aventis Pasteur SA  08/16/2004  Office of Enforcement  CGMP  No   
Bio-Rad Laboratories Inc.  10/13/2000  Office of Enforcement  Quality System Regulation  No   
BioMerieux, Inc.  07/29/2005  Office of Enforcement  CGMP/IVR Manufacturing  No   
Biotest AG  10/13/2000  Office of Enforcement  Quality System Regulation  No   
Catalent Pharma Solutions  03/28/2008  Office of Enforcement  CGMP Deviations  No   
Center Laboratories Inc.  03/10/2000  Office of Enforcement  GMP for Mfr Processing Packing Holding Drugs/Reporting Biological Products Deviations   No   
Chiron Corporation  12/09/2004  Office of Enforcement  CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated   No   
CoPharma Inc.  02/09/2001  Office of Enforcement  GMP of Manufacturing of Bulk Products/Adulterated   No   
Coulter Corporation  12/19/2002  Office of Enforcement  GMP for Blood and Blood Products/Quality System Regulation   No   
Crystal Laboratory, Inc.  08/06/2004  Office of Enforcement  Biological Product Establishment Standard/Adulterated   No   
Greer Laboratories, Inc.  06/24/2005  Office of Enforcement  CGMP for Finished Pharmaceutical   No   
IMTIX - SangStat  11/29/1999  Office of Enforcement  GMP for Finished Pharmaceuticals/Reporting Biological Product Deviations   No   
Immucor, Inc.  05/02/2008  Office of Enforcement  CGMP Deviations  No   
Merck & Co. Inc.  02/09/2001  Office of Enforcement  GMP for Finished Pharmaceuticals/Biologics Licensing   No   
Merck & Company, Inc.  07/22/2005  Office of Enforcement  Biologics License/Adulterated  No   
Merck & Company, Inc.  04/28/2008  Office of Enforcement  CGMP Manufacture of Licensed Biological Vaccine Products/Bulk Drug Substances/Components   No   
SP Pharmaceuticals LLC  09/11/2000  Office of Enforcement  Biological Products/GMP for Fisnished Pharmaceuticals   No   
Sanofi Pasteur  06/30/2006  Office of Enforcement  Current Good Manufacturing Practices   No   
ZLB Central Laboratory  11/03/1999  Office of Enforcement  GMP for Finished Pharmaceuticals   No   

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