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 ...
NEW YORK — The US Food and Drug Administration has issued warning letters to four direct-to-consumer health testing companies for selling unauthorized blood collection kits for HIV diagnosis.
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 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 December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, ...
The U.S. Food and Drug Administration has sent warning letters to four major retailers for continuing to sell baby formula linked to a nationwide outbreak of bacterial illness in infants, even after ...
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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