Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
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 ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...
If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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 ...