Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre ...
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 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 ...
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 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 ...
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) ...
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