The Trump Administration reversed course on plans to terminate the lease of a major Food and Drug Administration quality lab ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Medical Device Network on MSN1d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenueDexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Chemicals such as titanium dioxide and potassium bromate, whose safety has been debated, are allowed in foods in the United ...
and Mesa, Ariz. related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 ...
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