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Warning Letters 2006


2006 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 2006
Product/Issue Company/Individual Division Released Posted

Dyrenium (triamterene) capsules

 WellSpring DDMAC 12/19/2006 1/9/2007

November 2006
Product/Issue Company/Individual Division Released Posted

Seroquel

 AstraZeneca DDMAC 11/16/2006 11/20/2006

October 2006
Product/Issue Company/Individual Division Released Posted
BMIS Inspection (Warning Letter) E. Clinton Lawrence, MD DSI 11/16/2006 4/15/2008

Maxair Autohaler (pirbuterol acetate inhalation aerosol) (Warning Letter)

 3M Corporate Headquarters DDMAC 10/19/2006 10/20/2006

MD-GASTROVIEW (Warning Letter)

 Mallinckrodt Inc. DDMAC 10/13/2006 10/18/2006

Nevanac (nepafenac ophthalmic suspension) (Warning Letter)

 Alcon, Inc. DDMAC 10/20/2006 10/20/2006

ONTAK (denileukin diftitox) and Targretin (bexarotene) capsules (Warning Letter)

 Ligand Pharmaceuticals, Inc. DDMAC 10/23/2006 10/25/2006

Orapred (prednisolone sodium phosphate oral solution) (Warning Letter)

 BioMarin Pharmaceutical Inc. DDMAC 10/11/2006 10/11/2006

September 2006
Product/Issue Company/Individual Division Released Posted
Clinical Investigation (Warning Letter) Herman Zaharowitz, M.D. DSI 9/14/2006 9/26/2006

VoSpire ERQì (albuterol sulfate) Extended-Release Tablets (Warning Letter)

 DAVA Pharmaceuticals, Inc. DDMAC 9/21/2006 9/21/2006

Rythmol SR (propafenone HCl)extended release Capsules (Warning Letter)

 Reliant Pharmaceuticals, Inc. DDMAC 9/14/2006 9/15/2006

August 2006
Product/Issue Company/Individual Division Released Posted
BIMO inspection MDS Pharma Compliance 8/31/2006 9/11/2006
Clinical Investigation (Warning Letter) Professor Olga D. Ostroumova DSI 8/18/2006 10/5/2006

Prograf (tacrolimus capsules and injection) (Warning Letter)

 Astellas Pharma US, Inc. DDMAC 8/31/2006 9/5/2006

July 2006
Product/Issue Company/Individual Division Released Posted

Alimta (pemetrexed) for injectio

 Eli Lilly and Company DDMAC 7/27/2006 7/31/2006
BMIS Inspection (Warning Letter) Evangeline G. Gonzalez, M.D. DSI 7/6/2006 8/10/2006

June 2006
Product/Issue Company/Individual Division Released Posted

Zovirax (acyclovir) Ointment (Warning Letter)

 GlaxoSmithKline DDMAC 6/30/2006 6/30/2006

Hydase (hyaluronidase Injection) (Warning Letter)

 PrimaPharm, Inc. DDMAC 6/29/2006 6/30/2006
Inspection (Warning Letter) Cell Point DSI 6/15/2006 7/21/2006
Inspection (Warning Letter) Massimo Cristofanilli, M.D. DSI 6/15/2006 7/21/2006
Inspection (Warning Letter) MD Anderson Cancer Center DSI 6/15/2006 7/21/2006
Site Inspection (Warning Letter) Ranbaxy DMPQ 6/15/2006 6/23/2006

May 2006
Product/Issue Company/Individual Division Released Posted
BMIS Inspection (Warning Letter) North American Science Associates, Inc. DSI 5/11/2006 5/22/2006

Bupropion hydrochloride extended-release tablets (SR)

 Sandoz DDMAC 5/26/2006 5/30/2006

Spiriva Handihaler

 Boehringer Ingelheim Pharmaceuticals DDMAC 5/25/2006 5/25/2006

April 2006
Product/Issue Company/Individual Division Released Posted
Site Inspection (Warning Letter) Pliva Croatia Ltd. Compliance 4/28/2006 5/5/2006

Sotradecol (sodium tetradecyl sulfate injection) (Warning Letter)

 Bioniche Pharma Group Limited DDMAC 4/4/2006 4/18/2006

March 2006
Product/Issue Company/Individual Division Released Posted
Site Inspection (Warning Letter) Wockhardh, Ltd. DMPQ 2/21/2006 4/10/2006

Infergen

 InterMune, Inc. DDMAC 3/28/2006 4/3/2006

February 2006
Product/Issue Company/Individual Division Released Posted

M.V.I.-12 (Multi-Vitamin Infusion without Vitamin K) (Warning Letter)

 Mayne Pharma (USA) DDMAC 2/12/2006 3/8/2006

(NeutroSpec Kit for the Preparation of Technetium (99m Tc fanolesomab)

 Palatin Technologies DDMAC 2/16/2006 3/3/2006

January 2006
Product/Issue Company/Individual Division Released Posted

Benicar (olmesartan) Warning Letter

 Sankyo Pharma, Inc. DDMAC 1/6/2006 1/11/2006

Cenestin (snythetic conjugated estrogens, A) (Warning Letter)

 Duramed DDMAC 1/4/2006 1/18/2006
IRB Inspection (Warning Letter) Human Investigation Committee of Houston, Texas DSI 1/23/2006 1/30/2006

Loprox Shampoo (ciclopirox)

 Medicis Pharmaceutical DDMAC 1/42006 1/11/2006

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

    
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