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] |
December 2008 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
HUMIRA (adalimumab) Injection
|
Abbott Laboratories |
Division of Drug Marketing,
Advertising, and Communications |
12/16/2008 |
12/23/2008 |
Seroquel (quetiapine fumarate)
|
AstraZeneca |
Division of Drug Marketing,
Advertising, and Communications |
12/1/2008 |
12/4/2008 |
Xodol (hydrocodone bitartrate and acetaminophen) tablets
|
Victory Pharma, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
12/12/2008 |
12/15/2008 |
November 2008 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Cedax (ceftibuten capsules and ceftibuten for oral suspension) (Warning Letter)
|
Shionogi USA, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
11/14/2008 |
11/20/2008 |
Tracleer (bosentan) Tablets
|
Actelion Pharmaceuticals US, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
11/24/2008 |
11/25/2008 |
Voraxaze
|
Protherics, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
11/14/2008 |
11/20/2008 |
October 2008 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Bayer Aspirin with Hearth Advantage (Warning Letter) |
Bayer HealthCare L.L.C. |
Division of New Drugs & Labeling Compliance |
10/27/2008 |
10/28/2008 |
Bayer Women's Low Dose Aspirin + Calcium (Warning Letter) |
Bayer HealthCare L.L.C. |
Division of New Drugs & Labeling Compliance |
10/27/2008 |
10/28/2008 |
Clinical Investigation (Warning Letter) |
Richard Holub, M.D. |
Division of Scientific Investigations. |
10/1/2008 |
10/24/2008 |
Sensipar (cinacalcet) tablets
|
Amgen |
Division of Drug Marketing,
Advertising, and Communications |
10/27/2008 |
10/29/2008 |
SINUS SCIENCE Aerosol Medication Delivery System (Warning Letter) |
Aerosol Science Laboratories Inc. |
Division of New Drugs & Labeling Compliance |
10/29/2008 |
11/14/2008 |
YAZ (drospirenone and ethinyl estradiol) Tablets (Warning Letter)
|
Bayer HealthCare Pharmaceuticals, Inc. |
Division of Drug Marketing,
Advertising, and Communications |
10/3/2008 |
10/7/2008 |
September 2008 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Adderall XR Capsules (Warning Letter)
|
Shire Development |
Division of Drug Marketing,
Advertising, and Communications |
9/25/2008 |
9/26/2008 |
Clinical Investigation (Warning Letter) |
Gregory Gardziola |
Division of Scientific Investigations |
9/3/2008 |
10/24/2008 |
Concerta (methylphenidate HCl)
|
Johnson & Johnson |
Division of Drug Marketing,
Advertising, and Communications |
9/25/2008 |
9/26/2008 |
Focalin XR (dexmethylphenidate)
|
Novartis Pharmaceuticals |
Division of Drug Marketing,
Advertising, and Communications |
9/25/2008 |
9/26/2008 |
Methylin (methylphenidate HCl)
|
Mallinckrodt Inc. |
Division of Drug Marketing,
Advertising, and Communications |
9/25/2008 |
9/26/2008 |
Mirapex (pramipexole dihydrochloride) (Warning Letter)
|
Boehringer-Ingelheim |
Division of Drug Marketing,
Advertising, and Communications |
9/29/2008 |
10/2/2008 |
Strattera (atomoxetine HCl) (Warning Letter)
|
Eli Lilly & Company |
Division of Drug Marketing,
Advertising, and Communications |
9/25/2008 |
9/26/2008 |
|
Ranbaxy Laboratories Limited |
Division of Manufacturing and Product Quality |
9/16/2008 |
9/16/2008 |
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 |
Diovan (valsartan) Tablets
|
Novartis Pharmaceuticals |
Division of Drug Marketing,
Advertising, and Communications |
8/28/2008 |
9/26/2008 |
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
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