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