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.” ...
A federal report found the FDA is struggling to meet inspection targets at high-risk facilities. We look at why these checks ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...
A California company's dried lily flowers have been recalled because they may contain undeclared sulfites, according to the U.S. Food and Drug Administration. The FDA and Hayward, California-based ...
Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...
DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections generated a Form 483 that listed observations the FDA made ...
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