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.

Office of Prescription Drug Promotion Letters (formerly Division of Drug Marketing, Advertising, and Communications)

Office of Compliance/Immediate Office

Office of Drug Security, Integrity and Recalls

Office of Manufacturing and Product Quality Letters

Office of Scientific Investigations 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. 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.

Office of Prescription Drug Promotion

Company/Individual	Product/Issue	Issue Date
Alcon Research Ltd. Untitled Letter (PDF - 77KB) Promotional Material (PDF - 617KB)	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