The U.S. Food and Drug Administration (FDA) sent over 50 warning letters to GLP-1 drug compounders and manufacturers in September 2025. The agency warned the companies that their statements that ...
Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls. The letter comes in ...
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism ...
Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities. The warning ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...
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