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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/IssueCompany/IndividualDivisionReleasedPosted

HUMIRA (adalimumab) Injection

Abbott LaboratoriesDivision of Drug Marketing, Advertising, and Communications12/16/200812/23/2008

Seroquel (quetiapine fumarate)

AstraZenecaDivision of Drug Marketing, Advertising, and Communications12/1/200812/4/2008

Xodol (hydrocodone bitartrate and acetaminophen) tablets

Victory Pharma, Inc.Division of Drug Marketing, Advertising, and Communications12/12/200812/15/2008

November 2008
Product/IssueCompany/IndividualDivisionReleasedPosted

Cedax (ceftibuten capsules and ceftibuten for oral suspension) (Warning Letter)

Shionogi USA, Inc.Division of Drug Marketing, Advertising, and Communications11/14/200811/20/2008

Tracleer (bosentan) Tablets

Actelion Pharmaceuticals US, Inc.Division of Drug Marketing, Advertising, and Communications11/24/200811/25/2008

Voraxaze

Protherics, Inc.Division of Drug Marketing, Advertising, and Communications11/14/200811/20/2008

October 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Bayer Aspirin with Hearth Advantage (Warning Letter)Bayer HealthCare L.L.C.Division of New Drugs & Labeling Compliance10/27/200810/28/2008
Bayer Women's Low Dose Aspirin + Calcium (Warning Letter)Bayer HealthCare L.L.C.Division of New Drugs & Labeling Compliance10/27/200810/28/2008
Clinical Investigator (Warning Letter)Richard Holub, M.D.Division of Scientific Investigations.10/1/200810/24/2008

Sensipar (cinacalcet) tablets

AmgenDivision of Drug Marketing, Advertising, and Communications10/27/200810/29/2008
SINUS SCIENCE Aerosol Medication Delivery System (Warning Letter)Aerosol Science Laboratories Inc.Division of New Drugs & Labeling Compliance10/29/200811/14/2008

YAZ (drospirenone and ethinyl estradiol) Tablets (Warning Letter)

Bayer HealthCare Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications10/3/200810/7/2008

September 2008
Product/IssueCompany/IndividualDivisionReleasedPosted

Adderall XR Capsules (Warning Letter)

Shire DevelopmentDivision of Drug Marketing, Advertising, and Communications9/25/20089/26/2008
Clinical Investigator (Warning Letter)Gregory GardziolaDivision of Scientific Investigations9/3/200810/24/2008

Concerta (methylphenidate HCl)

Johnson & JohnsonDivision of Drug Marketing, Advertising, and Communications9/25/20089/26/2008

Focalin XR (dexmethylphenidate)

Novartis PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications9/25/20089/26/2008

Methylin (methylphenidate HCl)

Mallinckrodt Inc.Division of Drug Marketing, Advertising, and Communications9/25/20089/26/2008

Mirapex (pramipexole dihydrochloride) (Warning Letter)

Boehringer-IngelheimDivision of Drug Marketing, Advertising, and Communications9/29/200810/2/2008

Strattera (atomoxetine HCl) (Warning Letter)

Eli Lilly & CompanyDivision of Drug Marketing, Advertising, and Communications9/25/20089/26/2008
Ranbaxy Laboratories LimitedDivision of Manufacturing and Product Quality9/16/20089/16/2008

August 2008
Product/IssueCompany/IndividualDivisionReleasedPosted

Bystolic (nebivolol) Tablets (Warning Letter)

Forest Laboratories, Inc.Division of Drug Marketing, Advertising, and Communications8/28/20089/8/2008

Diovan (valsartan) Tablets

Novartis PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications8/28/20089/26/2008
Institutional Review Board (Warning Letter)Hospital Municipal de San Juan IRBDivision of Scientific Investigations8/15/20088/20/2008

June 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)Nagarjuna R. Ponugoti, M.D.Division of Scientific Investigations6/6/20087/9/2008
Sponsor-Applicant-Monitor-CRO (Warning Letter)Travanti Pharma, Inc.Division of Scientific Investigations6/30/20087/2/2008

May 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)Arturo Corces, M.D.Division of Scientific Investigations5/28/20087/9/2008
Sponsor-Investigator (Warning Letter)Willa A. Hsueh, M.D.Division of Scientific Investigations5/30/20087/9/2008
Sponsor/Investigator (Warning Letter)Edward Mostel, M.D..Division of Scientific Investigations5/16/20087/9/2008

Fosrenol

Shire Development, Inc.Division of Drug Marketing, Advertising, and Communications5/1/20085/8/2008

Trileptal (Warning Letter)

Novartis Pharmaceuticals CorporationDivision of Drug Marketing, Advertising, and Communications5/1/20085/8/2008

April 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Inspection (Warning Letter)Changzhou SPL Company, Ltd.Division of Manufacturing and Product Quality4/21/20084/21/2008

Peridex (Warning Letter)

Zila Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications4/18/20084/22/2008
Viagra (Warning Letter)Pfizer, Inc.Division of Drug Marketing, Advertising, and Communications4/16/20084/21/2008

March 2008
Product/IssueCompany/IndividualDivisionReleasedPosted

Avinza (Warning Letter)

King Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications3/24/20083/26/2008
Clinical Investigator (Warning Letter)Saroj Brar, M.D.Division of Scientific Investigations3/20/20084/22/2008
Clinical Investigator (Warning Letter)Ashok Shah, M.D.Division of Scientific Investigations3/19/20084/22/2008
Clinical Investigator (Warning Letter)Frank Whittier, M.D.Division of Scientific Investigations3/6/20084/22/2008
Institutional Review Board (Warning Letter)Coast Institutional Review BoardDivision or Scientific Investigations3/11/20083/26/2008

February 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)Kevin W. Klein, M.D.Division or Scientific Investigations2/13/20082/28/2008
Clinical Investigator (Warning Letter)Nasim Golzar, MDDivision of Scientific Investigations2/13/20085/15/2008
Institutional Review Board (Warning Letter)West Jefferson Medical Center IRBDivision of Scientific Investigations2/25/20084/1/2008

January 2008
Product/IssueCompany/IndividualDivisionReleasedPosted
Sponsor-Applicant-Monitor-Clinical Research Organization (Warning Letter)Replidyne, Inc.Division or Scientific Investigations1/18/20082/15/2008
Inspection (Warning Letter)Tomita Pharmaceutical Co., LtdDivision of Manufacturing and Product Quality1/14/20081/23/2008

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.