What is the FDA Alert System

Learn about the types of warning letters on FDA's website.

  • Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
  • To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA request.

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path hiddenPosted DateLetter Issue DateCompany nameIssuing office hiddenIssuing office hiddenRecipient Office Office hiddenIssuing office old hiddenLetter type condition hiddenIssuing OfficeState hiddenState hiddenRegulated Product hiddenSubjectTopics hiddenTopics and regulated product combined hiddenYear hiddenLetter typeResponse letterCloseout lettercheckresponse hidden
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  • Content current as of: