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. [more...]
2008
[2007] [2006]
[2005]
[2004]
[2003]
[2002]
[2001]
[2000]
[1999]
[1998]
[1997] |
August 2008 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Bystolic (nebivolol) Tablets (Warning Letter)
|
Forest Laboratories, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
8/28/2008 |
9/8/2008 |
Inspection (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 Investigation (Warning Letter) |
Nagarjuna R. Ponugoti, M.D. |
Division of Scientific Investigations |
6/6/2008 |
7/9/2008 |
Clinical Investigation (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 Investigation (Warning Letter) |
Arturo Corces, M.D. |
Division of Scientific Investigations |
5/28/2008 |
7/9/2008 |
Clinical Investigation (Warning Letter) |
Willa A. Hsueh, M.D. |
Division of Scientific Investigations |
5/30/2008 |
7/9/2008 |
Clinical Investigation (Warning Letter) |
Edward Mostel, M.D.. |
Division of Scientific Investigations |
5/16/2008 |
7/9/2008 |
Fosrenol
|
Shire Development, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
5/1/2008 |
5/8/2008 |
Trileptal (Warning Letter)
|
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)
|
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)
|
King Pharmaceuticals, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
3/24/2008 |
3/26/2008 |
Clinical Investigation (Warning Letter) |
Saroj Brar, M.D. |
Division of Scientific Investigations |
3/20/2008 |
4/22/2008 |
Clinical Investigation (Warning Letter) |
Ashok Shah, M.D. |
Division of Scientific Investigations |
3/19/2008 |
4/22/2008 |
Clinical Investigation (Warning Letter) |
Frank Whittier, M.D. |
Division of Scientific Investigations |
3/6/2008 |
4/22/2008 |
Inspection (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 |
BMIS Inspection (Warning Letter) |
Kevin W. Klein, M.D. |
Division or Scientific Investigations |
2/13/2008 |
2/28/2008 |
Clinical Investigation (Warning Letter) |
Nasim Golzar, MD |
Division of Scientific Investigations |
2/13/2008 |
5/15/2008 |
Inspection (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 |
BMIS Inspection (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 |
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.