Warning Letters and Untitled Letters
to Pharmaceutical Companies
2001

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.

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.

The letters are arranged in chronological order by month.  Click on the product name to view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.

Also see the "Cyber" Letters.

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Date created: January 11, 2006; updated April 15, 2008

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