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 ...
Drug Delivery Business2d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
MedTech Dive2d
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 ...
Fierce Biotech2d
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 ...
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.
National Law Review3d
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Will Trump Drug Tariffs Help Or Hurt The U.S.?
If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...
Fierce Pharma7d
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 ...
USFDA issues warning letter for Granules India Gagillapur plant, new product approvals to take a hit
The USFDA issued a warning letter to Granules India Ltd's Gagillapur facility after an August 2024 inspection highlighted ...
Wall Street Journal5d
DexCom Gets FDA Warning Letter After Inspections of Facilities
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 ...