Warning Letters 2008

2008 Warning Letters and Untitled Letters to Pharmaceutical Companies      
 

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 links in each month to view the letters in Adobe Acrobat format. [more...]

 

December 2008

Product/Issue	Company/Individual	Division	Released	Posted
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) Promotional 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 Investigator (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 Investigator (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
Institutional Review Board (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 Investigator (Warning Letter)	Nagarjuna R. Ponugoti, M.D.	Division of Scientific Investigations	6/6/2008	7/9/2008
Sponsor-Applicant-Monitor-CRO (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 Investigator (Warning Letter)	Arturo Corces, M.D.	Division of Scientific Investigations	5/28/2008	7/9/2008
Sponsor-Investigator (Warning Letter)	Willa A. Hsueh, M.D.	Division of Scientific Investigations	5/30/2008	7/9/2008
Sponsor/Investigator (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 Investigator (Warning Letter)	Saroj Brar, M.D.	Division of Scientific Investigations	3/20/2008	4/22/2008
Clinical Investigator (Warning Letter)	Ashok Shah, M.D.	Division of Scientific Investigations	3/19/2008	4/22/2008
Clinical Investigator (Warning Letter)	Frank Whittier, M.D.	Division of Scientific Investigations	3/6/2008	4/22/2008
Institutional Review Board (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
Clinical Investigator (Warning Letter)	Kevin W. Klein, M.D.	Division or Scientific Investigations	2/13/2008	2/28/2008
Clinical Investigator (Warning Letter)	Nasim Golzar, MD	Division of Scientific Investigations	2/13/2008	5/15/2008
Institutional Review Board (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
Sponsor-Applicant-Monitor-Clinical Research Organization (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:

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Freedom of Information Staff (HFI-35)
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The letters are arranged in chronological order by month.