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[e-drug] FDA enforcement actions involving pharmaceutical companies

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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