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Warning Letters

This page is designed to simplify the search for Warning Letters. Choose any of the six search categories and view or download the Warning Letter. Use the Warning Letters Search Form for advanced searching. Warning Letters displayed after June 25, 2001 are available in HTML 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 recipent of the letter directly. Inquiries to FDA should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at http://www.fda.gov/opacom/backgrounders/foiahand.html The Warning Letters are in PDF format, the ADOBE ACROBAT Reader is needed to review PDF files. Click on the ABOBE icon and download the free reader.