Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...

Dexcom announced today that it received a warning letter from the FDA following inspections of two company 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 ...

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 ...

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 ...