Drugs
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 |
|---|---|---|---|---|
| WellSpring | DDMAC | 12/19/2006 | 1/9/2007 |
November 2006
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
| AstraZeneca | DDMAC | 11/16/2006 | 11/20/2006 | |
| Clinical Investigator (Warning Letter) | Dr. Philip B. Schworer | DSI | 11/7/2006 | 11/7/2006 |
October 2006
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
| Clinical Investigator (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 Investigator (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 Investigator (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 |
|---|---|---|---|---|
| Eli Lilly and Company | DDMAC | 7/27/2006 | 7/31/2006 | |
| Clinical Investigator (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 |
| Sponsor-Applicant-Monitor-Clinical Research Organization (Warning Letter) | Cell Point | DSI | 6/15/2006 | 7/21/2006 |
| Clinical Investigator (Warning Letter) | Massimo Cristofanilli, M.D. | DSI | 6/15/2006 | 7/21/2006 |
| Institutional Review Board (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 |
|---|---|---|---|---|
| GLP for non-clinical laboratory studies (Warning Letter) | North American Science Associates, Inc. | DSI | 5/11/2006 | 5/22/2006 |
| Sandoz | DDMAC | 5/26/2006 | 5/30/2006 | |
| 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 |
| 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 |
| Institutional Review Board (Warning Letter) | Human Investigation Committee of Houston, Texas | DSI | 1/23/2006 | 1/30/2006 |
| Medicis Pharmaceutical | DDMAC | 1/42006 | 1/11/2006 |
Food and Drug Administration
Freedom of Information Staff (HFI-35)
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