Drugmaker Granules India’s U.S. subsidiary Granules Pharmaceuticals, Inc. (GPI) has completed U.S. Food and Drug Administration’s post-marketing adverse drug experience (PADE) inspection for all its entities in the U.S.
The inspection, conducted from July 31-August 3, and closed with zero observations, covered Granules’ PADE surveillance, receipts, evaluations, processing and reporting system for the marketed drug products worldwide. This was Granules India’s fourth FDA audit since March with zero observations, the company said on Friday.
Published - August 04, 2023 10:20 pm IST
