Warning Letters and Untitled Letters to Pharmaceutical Companies 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

FDA/Center for Drug Evaluation and Research

Warning Letters and Untitled Letters
to Pharmaceutical Companies
2008

These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Click on the month to view the letters in Adobe Acrobat format. [more...]

Product/Issue	Company/Individual	Division	Released	Posted
2008 [2007] [2006] [2005] [2004] [2003] [2002] [2001] [2000] [1999] [1998] [1997]
December 2008
HUMIRA (adalimumab) Injection Promotional Material	Abbott Laboratories	Division of Drug Marketing, Advertising, and Communications	12/16/2008	12/23/2008
Seroquel (quetiapine fumarate) Promotional Material	AstraZeneca	Division of Drug Marketing, Advertising, and Communications	12/1/2008	12/4/2008
Xodol (hydrocodone bitartrate and acetaminophen) tablets Promotional Material	Victory Pharma, Inc.	Division of Drug Marketing, Advertising, and Communications	12/12/2008	12/15/2008
November 2008
Product/Issue	Company/Individual	Division	Released	Posted
Cedax (ceftibuten capsules and ceftibuten for oral suspension) (Warning Letter) Promo tional Material	Shionogi USA, Inc.	Division of Drug Marketing, Advertising, and Communications	11/14/2008	11/20/2008
Tracleer (bosentan) Tablets Promotional Material	Actelion Pharmaceuticals US, Inc.	Division of Drug Marketing, Advertising, and Communications	11/24/2008	11/25/2008
Voraxaze Promotional Material	Protherics, Inc.	Division of Drug Marketing, Advertising, and Communications	11/14/2008	11/20/2008
October 2008
Product/Issue	Company/Individual	Division	Released	Posted
Bayer Aspirin with Hearth Advantage (Warning Letter)	Bayer HealthCare L.L.C.	Division of New Drugs & Labeling Compliance	10/27/2008	10/28/2008
Bayer Women's Low Dose Aspirin + Calcium (Warning Letter)	Bayer HealthCare L.L.C.	Division of New Drugs & Labeling Compliance	10/27/2008	10/28/2008
Clinical Investigation (Warning Letter)	Richard Holub, M.D.	Division of Scientific Investigations.	10/1/2008	10/24/2008
Sensipar (cinacalcet) tablets Promotional Material	Amgen	Division of Drug Marketing, Advertising, and Communications	10/27/2008	10/29/2008
SINUS SCIENCE Aerosol Medication Delivery System (Warning Letter)	Aerosol Science Laboratories Inc.	Division of New Drugs & Labeling Compliance	10/29/2008	11/14/2008
YAZ (drospirenone and ethinyl estradiol) Tablets (Warning Letter) Promotional Material	Bayer HealthCare Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	10/3/2008	10/7/2008
September 2008
Product/Issue	Company/Individual	Division	Released	Posted
Adderall XR Capsules (Warning Letter) Promotional Material	Shire Development	Division of Drug Marketing, Advertising, and Communications	9/25/2008	9/26/2008
Clinical Investigation (Warning Letter)	Gregory Gardziola	Division of Scientific Investigations	9/3/2008	10/24/2008
Concerta (methylphenidate HCl) Promotional Material	Johnson & Johnson	Division of Drug Marketing, Advertising, and Communications	9/25/2008	9/26/2008
Focalin XR (dexmethylphenidate) Promotional Material	Novartis Pharmaceuticals	Division of Drug Marketing, Advertising, and Communications	9/25/2008	9/26/2008
Methylin (methylphenidate HCl) Promotional Material	Mallinckrodt Inc.	Division of Drug Marketing, Advertising, and Communications	9/25/2008	9/26/2008
Mirapex (pramipexole dihydrochloride) (Warning Letter) Promotional Material	Boehringer-Ingelheim	Division of Drug Marketing, Advertising, and Communications	9/29/2008	10/2/2008
Strattera (atomoxetine HCl) (Warning Letter) Promotional Material	Eli Lilly & Company	Division of Drug Marketing, Advertising, and Communications	9/25/2008	9/26/2008
Warning Letter Dewas, India Warning Letter Batamandi (Unit II), in Paonta Sahib, India	Ranbaxy Laboratories Limited	Division of Manufacturing and Product Quality	9/16/2008	9/16/2008
August 2008
Product/Issue	Company/Individual	Division	Released	Posted
Bystolic (nebivolol) Tablets (Warning Letter) Promotional Material	Forest Laboratories, Inc.	Division of Drug Marketing, Advertising, and Communications	8/28/2008	9/8/2008
Diovan (valsartan) Tablets Promotional Material	Novartis Pharmaceuticals	Division of Drug Marketing, Advertising, and Communications	8/28/2008	9/26/2008
Inspection (Warning Letter)	Hospital Municipal de San Juan IRB	Division of Scientific Investigations	8/15/2008	8/20/2008
June 2008
Product/Issue	Company/Individual	Division	Released	Posted
Clinical Investigation (Warning Letter)	Nagarjuna R. Ponugoti, M.D.	Division of Scientific Investigations	6/6/2008	7/9/2008
Clinical Investigation (Warning Letter)	Travanti Pharma, Inc.	Division of Scientific Investigations	6/30/2008	7/2/2008
May 2008
Product/Issue	Company/Individual	Division	Released	Posted
Clinical Investigation (Warning Letter)	Arturo Corces, M.D.	Division of Scientific Investigations	5/28/2008	7/9/2008
Clinical Investigation (Warning Letter)	Willa A. Hsueh, M.D.	Division of Scientific Investigations	5/30/2008	7/9/2008
Clinical Investigation (Warning Letter)	Edward Mostel, M.D..	Division of Scientific Investigations	5/16/2008	7/9/2008
Fosrenol Promotional Material	Shire Development, Inc.	Division of Drug Marketing, Advertising, and Communications	5/1/2008	5/8/2008
Trileptal (Warning Letter) Promotional Material	Novartis Pharmaceuticals Corporation	Division of Drug Marketing, Advertising, and Communications	5/1/2008	5/8/2008
April 2008
Product/Issue	Company/Individual	Division	Released	Posted
Inspection (Warning Letter)	Changzhou SPL Company, Ltd.	Division of Manufacturing and Product Quality	4/21/2008	4/21/2008
Peridex (Warning Letter) Promotional Material	Zila Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	4/18/2008	4/22/2008
Viagra (Warning Letter)	Pfizer, Inc.	Division of Drug Marketing, Advertising, and Communications	4/16/2008	4/21/2008
March 2008
Product/Issue	Company/Individual	Division	Released	Posted
Avinza (Warning Letter) Promotional Material	King Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	3/24/2008	3/26/2008
Clinical Investigation (Warning Letter)	Saroj Brar, M.D.	Division of Scientific Investigations	3/20/2008	4/22/2008
Clinical Investigation (Warning Letter)	Ashok Shah, M.D.	Division of Scientific Investigations	3/19/2008	4/22/2008
Clinical Investigation (Warning Letter)	Frank Whittier, M.D.	Division of Scientific Investigations	3/6/2008	4/22/2008
Inspection (Warning Letter)	Coast Institutional Review Board	Division or Scientific Investigations	3/11/2008	3/26/2008
February 2008
Product/Issue	Company/Individual	Division	Released	Posted
BMIS Inspection (Warning Letter)	Kevin W. Klein, M.D.	Division or Scientific Investigations	2/13/2008	2/28/2008
Clinical Investigation (Warning Letter)	Nasim Golzar, MD	Division of Scientific Investigations	2/13/2008	5/15/2008
Inspection (Warning Letter)	West Jefferson Medical Center IRB	Division of Scientific Investigations	2/25/2008	4/1/2008
January 2008
Product/Issue	Company/Individual	Division	Released	Posted
BMIS Inspection (Warning Letter)	Replidyne, Inc.	Division or Scientific Investigations	1/18/2008	2/15/2008
Inspection (Warning Letter)	Tomita Pharmaceutical Co., Ltd	Division of Manufacturing and Product Quality	1/14/2008	1/23/2008

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA FOI Page.

The letters are arranged in chronological order by month. Click on the product name to view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.

Also see the "Cyber" Letters.

Date created: February 28, 2008; updated December 23, 2008