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2. Warning Letters | FDA - U.S. Food and Drug Administration

   www.fda.gov/.../compliance-actions-and-activities/warning-letters

   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 ...

3. Warning Letters and Notice of Violation Letters to Pharmaceutical...

   www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice...

   CDER Warning Letters notify manufacturers of significant violations of FDA regulations. CDER works with the company to ensure correction.

4. About Warning and Close-Out Letters | FDA

   www.fda.gov/.../warning-letters/about-warning-and-close-out-letters

   This page reviews the types of warning letters found on the FDA website. General FDA Warning Letters. When FDA identifies what it believes are significant violation(s) of federal requirement(s ...

5. Warning Letters - Health Fraud | FDA

   www.fda.gov/consumers/health-fraud-scams/warning-letters-health-fraud

   Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. For all FDA Warning Letters, click here.

6. Warning Letters Related to Food, Beverages, and Dietary...

   www.fda.gov/food/compliance-enforcement-food/warning-letters-related-food...

   Warning Letters Related to Food, Beverages, and Dietary Supplements. When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification ...

7. Letters to Industry | FDA - U.S. Food and Drug Administration

   www.fda.gov/medical-devices/industry-medical-devices/letters-industry

   View all Warning Letters, including those issued by CDRH, at FDA's main page for Warning Letters; Untitled Letters

8. 2021 Warning Letters - Health Fraud | FDA - U.S. Food and Drug...

   www.fda.gov/consumers/health-fraud-scams/2021-warning-letters-health-fraud

   Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. For all FDA Warning Letters, click here.

9. CARsgen Therapeutics Corporation - 686504 - 07/26/2024 | FDA

   www.fda.gov/.../warning-letters/carsgen-therapeutics-corporation-686504-07262024

   It is a prohibited act under section 301 (k) of the FD&C Act, 21 U.S.C. § 331 (k), to do any act with respect to a drug that results in the drug being adulterated, while held for sale after ...

10. PepsiCo, Inc. - 679972 - 06/12/2024 | FDA

    www.fda.gov/.../warning-letters/pepsico-inc-679972-06122024

    This inspection was initiated in response to a Reportable Food Registry (RFR) report and recall of your granola bars and granola cereals announced on December 15, 2023. FDA also collected ...

11. Intas Pharmaceuticals Limited - 652067 - 07/28/2023 | FDA

    www.fda.gov/.../warning-letters/intas-pharmaceuticals-limited-652067-07282023

    This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts ...