MedTech Dive6d
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 ...
FiercePharma18d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
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 ...
Business Insider9d
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
the FDA cited deficiencies in the response letters sent by the company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the company in connection ...
Alembic Pharma's Vadodara facility gets one Form 483 observation from US FDA
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 ...
Shilpa Medicare's Raichur units gets Form 483 with one observation from US FDA
Shilpa Medicare said that the United States Food and Drugs Administration (US FDA), post an inspection, has issued Form 483 with one observation to the company's unit located at Raichur.
Yahoo Finance6d
Dexcom receives warning letter based on FDA inspections of 2 plants
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 ...