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.
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.
[2008] [2007]
2006
[2005]
[2004]
[2003]
[2002]
[2001]
[2000]
[1999]
[1998]
[1997] |
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 injection
|
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 |