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 ...
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 ...
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 ...
On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood ...
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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