Warning Letters | FDA - U.S. Food and Drug Administration
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
About Warning and Close-Out Letters | FDA
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 ...
Warning Letters and Notice of Violation Letters to Pharmaceutical ...
Oct 25, 2023 · CDER Warning Letters notify manufacturers of significant violations of FDA regulations. CDER works with the company to ensure correction.
Warning Letters - Health Fraud | FDA - U.S. Food and Drug …
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.
Letters to Industry | FDA - U.S. Food and Drug Administration
These primarily include Warning Letters, Untitled Letters, "It Has Come To Our Attention" letters and letters used to communicate with industry.
Sun Pharmaceutical Industries Limited - 677337 - 06/18/2024 | FDA
Jul 2, 2024 · If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately ...
Colgate-Palmolive/Tom's of Maine, Inc. - 687043 - 11/05/2024
Nov 19, 2024 · 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 ...
CARsgen Therapeutics Corporation - 686504 - 07/26/2024 | FDA
Aug 27, 2024 · At the conclusion of the inspection, FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form 483), documenting significant CGMP violations observed during the inspection.
Zydus Lifesciences Limited - 685224 - 08/29/2024 | FDA
Sep 10, 2024 · 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 ...
PepsiCo, Inc. - 679972 - 06/12/2024 | FDA
After reviewing the inspectional findings and the response provided by your firm, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the ...