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

(Reuters) -Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration ...

DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San ...

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

Mumbai: Alkem Labs has announced the completion of the inspection at the Company's Bioequivalence Center located at Taloja, ...

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

and certainly replying to 483's and Warning Letters ... information and tools they require to prepare for and manage an FDA inspection efficiently, effectively, and successfully.

of US FDA. The inspection covered both clinical & bioanalytical phases of three bioavailability and bioequivalence (BA/BE) studies submitted by clients, to the US Food and Drug Administration. The ...

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

FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections generated a Form 483 that listed observations the FDA made ...

The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7 ...