Warning Letters 2013
These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters.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.
Office of Prescription Drug Promotion
Company/Individual | Product/Issue | Issue Date |
---|---|---|
Alcon Research Ltd.
| NDA 021545 Pataday (olopatadine hydrochloride ophthalmic solution) 0.2% | 2/5/13 |
Office of Compliance/Immediate Office
Company/Individual | Product/Issue | Issue Date |
---|---|---|
Flu and Cold Defense LLC (WARNING LETTER) | False and misleading statements; marketing of product GermBullet on www.germbullet.com and www.nsaroma.com | 1/24/13 |
Office of Drug Security, Integrity and Recalls
Company/Individual | Product/Issue | Issue Date |
---|---|---|
Office of Manufacturing and Product Quality
Company/Individual | Product/Issue | Issue Date |
---|---|---|
P.A. Benjamin Manufacturing Co., Ltd. (WARNING LETTER) | regulations for finished pharmaceuticals | 1/29/13 |
Office of Scientific Investigations
Company/Individual | Product/Issue | Issue Date |
---|---|---|
Singing River Health System IRB (WARNING LETTER) | Institutional Review Board | 2/1/13 |
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