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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 in the
- About Warning and Close-Out Letters | FDA
Information about warning letters and close-out letters posted on the FDA website
- Warning Letters and Notice of Violation Letters to Pharmaceutical . . .
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
- Search | FDA
Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, … or other health fraud* - related violations For all FDA Warning Letters, click here
- Letters to Industry | FDA
These primarily include Warning Letters, Untitled Letters, "It Has Come To Our Attention" letters and letters used to communicate with industry
- Search | FDA
To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar The manufacturer warning letters include those for products for
- WHOOP, Inc. - 709755 - 07 14 2025 | FDA
Your firm sent a letter dated June 2, 2025, to describe the purpose of the BPI feature, how it works, and why you believe it is not a medical device subject to FDA regulatory authority
- Royal Philips - 709948 - 09 09 2025 | FDA
Your response should be comprehensive and address any outstanding violations included in this Warning Letter
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