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This page is designed to simplify the search for Warning Letters and Responses. Choose any of the seven search categories and view or download the Warning Letter or Response. Use the Warning Letters and Responses Search Form for advanced searching. All Warning Letters and Responses are available in PDF format. PDF documents may be read with a free copy of the Adobe Acrobat Reader. Warning Letters posted after June 25, 2001 and Responses posted after September 22, 2003 are also 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 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 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 Food and Drug Administration cannot assure the accuracy of information submitted to the Agency in response to a Warning Letter without a complete review of the submitted materials and resolution of the issues discussed therein. However, to make certain information available to the public, when a recipient of a Warning Letter requests that the agency post the recipient's Response to that Warning Letter, and provides that Response electronically in a word processing format, the agency will post that Response. Posted Responses are redacted to the extent permitted by the Freedom of Information Act. The agency reserves the right not to post certain Responses, such as when posting likely would mislead the public about the safety or efficacy of a regulated product.