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 ...
Fierce Biotech3d
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 ...
Fierce Pharma8d
Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant
Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...
MedTech Dive3d
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 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 ...
Reuters7d
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
March 7 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab said it has received a warning ... A Form 483 is a type of agency report containing "observations" that FDA inspectors ...
Business Insider5d
Wells sees no material impact from DexCom warning letter
The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its two inspections in ...
Yahoo Finance3d
Dexcom receives warning letter based on FDA inspections of 2 plants
However, the company still received a warning letter, which “cited deficiencies in the response letters sent by [Dexcom] to the FDA following the Form 483.” BTIG analysts, in a Sunday note to ...