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  5. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
  1. Enforcement Activities | FDA

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

1998-2014 Warning Letters are archived. To view them, please see the FDA Archive

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

"Cyber" letters are sent electronically via the Internet to web sites that offer to sell online prescription drugs that may be illegal.  The letters warn these web site operators that they may be engaged in illegal activities and informs them of the laws that govern prescription drug sales.  

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 web site, 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

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