Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
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 has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
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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.” ...
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
The FDA cited issues with DexCom’s response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7, 2024, ...
DexCom DXCM-0.65%decrease; red down pointing triangle received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is ...
March 7 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key ...
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