Dexcom receives FDA warning letter for 2 manufacturing sites
Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...
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DexCom CGM Sensor Sales to Continue Despite FDA Warning Letter
DXCM faces an FDA warning over manufacturing issues, but operations remain unaffected. However, supply-chain risks and rising ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
Medical Device Network on MSN3d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenue
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Fierce Biotech4d
Dexcom receives FDA warning letter over CGM manufacturing issues
Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...
MedTech Dive4d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Drug Delivery Business4d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
Reuters8d
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...
DexCom falls 7% to $71.99 after receiving warning letter from FDA
EST DexCom (DXCM) falls 7% to $71.99 after receiving warning letter from FDADiscover the Best Stocks and Maximize Your Portfolio: See ...
Wall Street Journal7d
DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom DXCM-2.10%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 ...