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Warning Letters | FDA 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
Discover our comprehensive searchable FDA enforcement . . . The database includes all FDA Warning Letters, Untitled Letters, and Cyber Letters — plus Determination Letters issued by the U S Department of Health and Human Services Office for Human Research Protections (OHRP) — dating back to July 1982
Warning Letters and Notice of Violation Letters to . . . Visit the FOI page for instructions on how to submit an FOI request or for more information on the status of an issue in a particular warning letter or notice of violation
About Warning and Close-Out Letters | FDA These letters, sorted by month, only cover Division of Drug Marketing and Communications and Drug Warning Letters Some of the letters have been redacted or edited to remove confidential
FDA Warning Letters: How To Respond in 2025 Learn what FDA warning letters mean, common reasons for issuance, and how to respond to protect your business from regulatory risks