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

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom ...

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...

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, 2024, ...

Alembic Pharmaceuticals stated that the United States Food and Drug Administration (US FDA) had conducted an inspection at the company's bioequivalence facility located at Vadodara from 3rd to 7th of ...

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

A Form-483 with six observations was issued by the U.S. FDA after the General GMP inspection of the facility from February 11-17. The observations are largely around improvement of procedures and ...

U.S. FDA issues 3 observations to Gland Pharma ... The inspection concluded with three Form 483 observations,” Gland Pharma said in a filing on Tuesday. The observations are procedural in ...

The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...

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 ...

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...