E-DRUG: FDA enforcement actions involving pharmaceutical companies
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[The USA has been criticising the WHO pre-qualification scheme for
some time. Here's a revealing message from IP-HEALTH about the USA
domestic practices. Crossposted with thanks. WB]
With all of the discussion of the WHO pre-qualification program, it is
perhaps useful to note that violations of regulatory requirements are
pretty common, anywhere the regulatory authority has the capacity to
monitor company actions. This is a partial list of US FDA enforcement
actions, put together by Michael Palmedo. The existence of documented
violations does not mean that you cannot trust the quality of products
offered in the US market, or that the FDA isn't doing its job. On the
contrary, the main criticism of the FDA is that it does not monitor
enough, and issue more enforcement actions. The WHO pre-qualification
program will, like the FDA often does, discover areas where companies
are out of compliance. The FDA does not always pull the products from
the shelves for every violations, and neither should programs like the
Global Fund, unless the violation warrants such action.
Jamie Love
http://www.accessdata.fda.gov/scripts/wlcfm/cindex.cfm
Abbott Laboratories 7/19/02
Postmarketing Reporting of Adverse Drug Experience
http://www.fda.gov/foi/warning_letters/g3420d.htm
Abbott Laboratories 10/15/02
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3626d.htm
Abbott Laboratories, Inc. 3/25/04
Quality System Regulation/Adulterated
http://www.fda.gov/foi/warning_letters/g4643d.htm
Abbott Laboratories, Inc.. 9/24/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3703d.htm
Able Laboratories Inc. 4/19/04
Postmarketing Adverse Drug Experience Reporting Requirements
http://www.fda.gov/foi/warning_letters/g4651d.htm
Aliachem A.S. 1/15/04
Good Manufacturing Practices/Active Pharmaceutical Ingredients/Adulterated
http://www.fda.gov/foi/warning_letters/g4706d.htm
Allergan, Inc. - 6/23/03
BOTOX/False & Misleading Material/Misbranded
http://www.fda.gov/foi/warning_letters/g4093d.htm
American Analytical Chemistry Laboratories, Ltd. - 2/06/03
CGMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4023d.htm
Amgen, Inc. - Amgen, Inc.
Biologics License/Adulterated
http://www.fda.gov/foi/warning_letters/g4235d.htm
Aqua Micron LLC - 12/31/03
CGMP/Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4566d.htm
AstraZeneca Pharmaceuticals LP - 2/22/02
CGMP/Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3189d.htm
Aventis Behring, L.L.C. - 10/12/04
Promotional Claims/False & Misleading
http://www.fda.gov/foi/warning_letters/g5004d.htm
Aventis Bio-Services, Inc. 11/05/02
CGMP Regulations for Blood & Blood Components/CGMP for Finished
Pharmaceuticals
http://www.fda.gov/foi/warning_letters/g3798d.htm
Aventis Pasteur SA - 8/16/04
CGMP
http://www.fda.gov/foi/warning_letters/g4921d.htm
Baxter Healthcare Corporation - 5/25/04
Promotional Claims/Misbranded
http://www.fda.gov/foi/warning_letters/g4735d.htm
Baxter Healthcare Corporation - Baxter Healthcare Corporation
Promotional Claims/Misbranded
http://www.fda.gov/foi/warning_letters/g4699d.htm
Bayer Corporation - 6/17/04
Quality System Regulation/Adulterated
http://www.fda.gov/foi/warning_letters/g4851d.htm
Berlex Laboratories, Inc. - 3/11/02
Quinaglute Dura-Tabs/CGMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3168d.htm
Best Formulations - 10/29/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3644d.htm
Bigmar-Bioren SA - 8/03/04
Current Good Mfg Practice Regulations/Adulterated
http://www.fda.gov/foi/warning_letters/g4925d.htm
Biozone Laboratories - 4/01/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3183d.htm
Boehringer Ingelheim Pharmaceuticals, Inc. - 9/23/04
Labeling/False & Misleading
http://www.fda.gov/foi/warning_letters/g4973d.htm
Bradley Pharmaceuticals, Inc. - 11/04/04
Promotional Claims/False & Misleading/Misbranded
http://www.fda.gov/foi/warning_letters/g5100d.htm
Bristol-Myers Squibb Company - 8/07/03
Drug Labeling/Promotional Claims/Misbranded
http://www.fda.gov/foi/warning_letters/g4200d.htm
Bristol-Myers Squibb Manufacturing Company - 10/23/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3655d.htm
C & K Manufacturing & Sales Co., LLC - 6/23/04
Unapproved New Drug
http://www.fda.gov/foi/warning_letters/g4828d.htm
Cancer Therapeutics, Inc. - 11/18/03
New Drug
http://www.fda.gov/foi/warning_letters/g4428d.htm
Carolina Pharmaceuticals, Inc. - 3/12/04
New Drug
http://www.fda.gov/foi/warning_letters/g4569d.htm
Celsus Laboratories, Inc - 11/12/02
GMP for Finished Pharmaceuticals (Active Pharmaceutical
Ingredient)/Adulterated
http://www.fda.gov/foi/warning_letters/g3716d.htm
Chelationcare Centers USA LLC - 9/30/03
New Drugs/Drug Establishment Registration/Misbranded
http://www.fda.gov/foi/warning_letters/g4335d.htm
ChemSource Corporation - 11/15/02
Current Good Manufacturing Practice of Active Pharmaceutical Ingredients
/Adulterated
http://www.fda.gov/foi/warning_letters/g3695d.htm
ChiRhoClin, Inc. - 4/28/04
Postmarketing Adverse Drug Experience Reporting Requirements
http://www.fda.gov/foi/warning_letters/g4670d.htm
Chiron Corporation - 12/09/04
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g5103d.htm
CIDEC Corporation - 10/31/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3647d.htm
Clonmel Healthcare Ltd. - 7/13/03
Postmarketing Reporting of Adverse Drug Experience
http://www.fda.gov/foi/warning_letters/g4138d.htm
Complete Care, Inc. - Complete Care, Inc.
CGMP in Finished Pharmaceuticals/Lacks Registration/Adulterated/Misbranded
http://www.fda.gov/foi/warning_letters/g3784d.htm
Concept Laboratories, Inc. - Concept Laboratories, Inc.
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3839d.htm
Consolidated Chemical, Inc. - 3/23/04
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4642d.htm
Crown Laboratories, Inc. - 2/28/03
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3869d.htm
Crystal Laboratory, Inc. - 8/06/04
Biological Product Establishment Standard/Adulterated
http://www.fda.gov/foi/warning_letters/g4912d.htm
Custom Industrial Analysis Laboratories, Inc. - 5/18/04
Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4770d.htm
D.S.C. Products, Inc. - 7/09/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3404d.htm
Delta Pharma, Inc. - 9/17/04
New Drug/Adulterated/Misbranded
http://www.fda.gov/foi/warning_letters/g4965d.htm
Delta Synthetic Co., Ltd - 1/05/04
Good Manufacturing Practices/Active Pharmaceutical Ingredients/Adulterated
http://www.fda.gov/foi/warning_letters/g4707d.htm
Earlham College - 7/29/02
GMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3419d.htm
Eastern Medical Equipment Distributors, Inc. - 12/17/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3775d.htm
Enka Products Company, Inc. - 1/08/03
New Drug/GMP for Finished Pharmaceuticals/Adulterated/Misbranded
http://www.fda.gov/foi/warning_letters/g4064d.htm
Eon Labs, Inc. - 2/06/03
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3823d.htm
Ferndale Laboratories, Inc. - 11/19/04
Lacks Approved New Drug Application/Labeling/Misbranded
http://www.fda.gov/foi/warning_letters/g5079d.htm
Forest Laboratories, Inc. - 8/07/03
New Drug/GMP for Finished Pharmaceuticals/GMP for Mfr, Processing,
Holding Drugs/Adulterated
http://www.fda.gov/foi/warning_letters/g4190d.htm
Furness Medical Inc. - 7/25/02
Medical Gases/Current Good Manufacturing Practice for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3436d.htm
Garland Welding Supply Co. Inc. - 9/23/03
GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4313d.htm
Gilead Sciences, Inc. - 7/29/03
Drug Labeling/Promotional Claims/Misbranded
http://www.fda.gov/foi/warning_letters/g4180d.htm
GlaxoSmithKline Biologics S.A. - 7/06/04
Promotional Claims/False & Misleading
http://www.fda.gov/foi/warning_letters/g4810d.htm
Guardian Drug Company, Inc. - 9/15/04
CGMP/Adulterated
http://www.fda.gov/foi/warning_letters/g4998d.htm
Gulf Medical Services - 12/16/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3787d.htm
Hartz Mountain Corporation 10/22/03
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4627d.htm
Hobart Laboratories, Inc. - 12/06/02
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3734d.htm
Hoffman-La Roche Inc - 5/29/03
Misleading Promotional Materials
http://www.fda.gov/foi/warning_letters/g4059d.htm
HomeReach, Inc. - 9/24/02
GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3519d.htm
Icon Laboratories - 2/04/03
Over-the Counter Drug/CGMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3827d.htm
Integra Chemical Company - 6/13/02
GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3379d.htm
Janssen Pharmaceutica, Inc. - 4/19/04
Risperdal/Dear Healthcare Provider Letter/False, Misleading Claims
http://www.fda.gov/foi/warning_letters/g4628d.htm
Janssen Pharmaceutica, Inc. - 9/02/04
Promotional Claims/False & Misleading
http://www.fda.gov/foi/warning_letters/g4934d.htm
K.C. Pharmaceuticals, Inc. - 11/19/02
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3698d.htm
Kos Pharmaceuticals, Inc. - 12/29/03
Good Manufacturing Processing, Packing, Holding/Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4502d.htm
LifeSouth Community Blood Centers, Inc. - 9/26/03
GMP for Finished Pharmaceuticals/GMP for Blood & Blood Components
http://www.fda.gov/foi/warning_letters/g4328d.htm
Mayne Pharma Pty., Ltd. - 11/21/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3723d.htm
Medpointe Healthcare, Inc. - 7/22/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3435d.htm
Natchez Animal Supply Company - 10/10/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3543d.htm
Natureplex, LLC - 8/18/04
Current Good Mfg Practice Regulation/Adulterated/Misbranded
http://www.fda.gov/foi/warning_letters/g4946d.htm
Novartis Pharmaceuticals Corporation - 4/21/04
Diovan/False & Misleading Promotional Claims
http://www.fda.gov/foi/warning_letters/g4652d.htm
Novo Nordisk Pharmaceuticals, Inc. - 8/09/04
Promotional Claims/False & Misleading
http://www.fda.gov/foi/warning_letters/g4906d.htm
Nutra Med, Inc. - 10/02/03
GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4357d.htm
Old Hickory Medicine Company, Inc. - 4/21/04
Current Good Manufacturing Practice for Finished
Pharmaceuticals/Misbranded/Adulterated
http://www.fda.gov/foi/warning_letters/g4653d.htm
OMRIX biopharmaceuticals, Ltd. - 5/27/04
Promotional Claims/Misbranded
http://www.fda.gov/foi/warning_letters/g4782d.htm
Organon USA Inc. - 9/29/03
GMP Finished Pharmaceuticals/Postmarketing/Reporting Adverse Drug
Experiences/Adulterated
http://www.fda.gov/foi/warning_letters/g4355d.htm
Ortho-McNeil Pharmaceutical, Inc. - 9/15/04
Promotional Claims/False & Misleading
http://www.fda.gov/foi/warning_letters/g4968d.htm
Pediatric Services of America, Inc. - 2/28/03
Liquid Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3868d.htm
Pharma Fab - 6/15/04
GMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4897d.htm
Pharmaceutical Formulations, Inc. - 5/05/04
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4683d.htm
Pharmacia - 4/17/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3212d.htm
Pharmacia & Upjohn AB - 5/20/97
GMP for Finished Pharmaceuticals/Biologics Establishment Standards Licensing
http://www.fda.gov/foi/warning_letters/g4485d.pdf
Pharmpak, Inc. - 2/27/04
GMP for Finished Pharmaceuticals/Drug Repackaging/Adulterated
http://www.fda.gov/foi/warning_letters/g4587d.htm
PLIVA, Inc. - 10/03/03
GMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4358d.htm
PrePark Systems, Inc. - 7/18/03
GMP Manufacturer, Processing, Packing, Holding Drugs/Adulterated
http://www.fda.gov/foi/warning_letters/g4152d.htm
Pride and Power, Inc. - 3/03/03
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3870d.htm
Purdue Pharma L.P. - 1/17/03
Oxycontin/False and Misleading Advertising
http://www.fda.gov/foi/warning_letters/g3797d.htm
PureTek Corporation - 2/10/03
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3833d.htm
Qualis, Inc. - 6/23/04
GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4802d.htm
R.W.K. Inc - 4/23/02
CGMP/Finished Pharmaceuticals/Oxygen Transfilling Facility/Adulterated
http://www.fda.gov/foi/warning_letters/g3209d.htm
Red River Pharmacy Services, Inc. - 12/17/04
Active Pharmaceutical Ingredient/Adulterated
http://www.fda.gov/foi/warning_letters/g5140d.htm
Respi Care Group of Puerto Rico - 12/20/04
Unapproved New Drug/Adulterated/Misbranded
http://www.fda.gov/foi/warning_letters/g5139d.htm
Sandoz GmbH - 3/29/04
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4633d.htm
Searle, Ltd. - 12/27/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3766d.htm
Shanghai Medical Ltd - 2/10/04
CGMP/Active Pharmaceutical Ingredients/Adulterated
http://www.fda.gov/foi/warning_letters/g4541d.htm
Sharp - 8/13/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3470d.htm
SP Pharmaceuticals LLC - 9/11/00
Biological Products/GMP for Finished Pharmaceuticals
http://www.fda.gov/foi/warning_letters/g4483d.pdf
Spectrum Chemicals & Laboratory Products - 6/07/04
New Drug/Misbranded
http://www.fda.gov/foi/warning_letters/g4765d.htm
Syntho Pharmaceuticals, Inc. - 3/14/03
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g4638d.htm
Titan Pharmaceuticals, Inc. - 4/15/02
Sponsor/Monitor/Contract Research Organization
http://www.fda.gov/foi/warning_letters/g3180d.htm
Tri-Med Laboratories, Inc. - 4/28/04
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4687d.htm
Tri-State Analytical Laboratory LLC - 10/22/03
GMP for Finished Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4372d.htm
TYA Pharmaceuticals - 8/06/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3451d.htm
Ultra-Seal Corporation - 7/22/04
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g4873d.htm
Unico Holdings, Inc. - 10/18/02
CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3654d.htm
Unit Dose Packaging, Inc. - 8/29/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3490d.htm
Vintage Pharmaceuticals, Inc. - 5/26/04
Postmarketing Adverse Drug Experience
http://www.fda.gov/foi/warning_letters/g4901d.htm
Vintage Pharmaceuticals, LLC - 5/20/02
Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals
http://www.fda.gov/foi/warning_letters/g3318d.htm
Vita-Erb, Ltd. - 6/07/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3305d.htm
VMM Enterprises, Inc. - 3/05/04
Current Good Manufacturing Practice for Finished
Pharmaceuticals/Misbranded/Adulterated
http://www.fda.gov/foi/warning_letters/g4788d.htm
Wallace O'Farrell, Inc. - 8/07/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3441d.htm
Wallach Surgical Devices, Inc. 12/20/02
CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing,
Packing, or Holding/Adulterated
http://www.fda.gov/foi/warning_letters/g3777d.htm
West Argo, Inc. - 3/28/02
Current Good Manufacturing Practices for Finished
Pharmaceuticals/Adulterated
http://www.fda.gov/foi/warning_letters/g3173d.htm
Xanodyne Pharmacal, Inc. 11/14/02
Division of Drug Marketing, Advertising, and Communications
http://www.fda.gov/foi/warning_letters/g3673d.htm
Xttrium Laboratories, Inc. - 12/30/03
Postmarketing Reporting of Adverse Drug Experience
http://www.fda.gov/foi/warning_letters/g4503d.htm
--
James Love, Director, CPTech, http://www.cptech.org
Consumer Project on Technology in Washington, DC
PO Box 19367, Washington, DC 20036, USA
Tel.: 1.202.387.8030, fax: 1.202.234.5176
Consumer Project on Technology in Geneva
1 Route des Morillons, CP 2100, 1211 Geneva 2, Switzerland
Tel: +41 22 791 6727
Mobile +1.202.361.3040
james.love@cptech.org
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