Compliance Activities

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

These letters are supplied by the CDER Freedom of  Information Office (FOI).   This page only covers letters issued by the Division of Drug Marketing, Advertising, and Communications and by Headquarters.  For District Office warning letters, please 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.

Recently FDA has begun  issuing "cyber" letters, letters sent electronically via the Internet, to web sites that offer to sell online prescription drugs that may be illegal.  The letters warn these website operators that they may be engaged in illegal activities and informs them of the laws that govern prescription drug sales.  A Press Release dated Feb. 2, 2000 describes these "cyber" letters.  "Cyber" Letters.

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.

The letters are arranged in chronological order by year and month.  All letters are in Adobe Acrobat (PDF) format [Adobe Acrobat download instructions].

FDA/Center for Drug Evaluation and Research
Last Updated: January 23, 2004
Originator: OTCOM/DML
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