Granules Pharma completes USFDA PADE Inspection with zero observations

Granules India announced that Granules Pharmaceuticals located in Chantilly, Virginia, US has successfully completed the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection for all its entities in the US, including Granules India. The inspection was closed with zero observations.

The inspection was conducted at Granules Pharmaceuticals from July 31, 2023 to August 03, 2023. This inspection covered the Granules’ PADE surveillance, receipts, evaluations, processing and reporting system for the marketed drug products worldwide.

This is Granules India’s fourth FDA audit since March with zero observations .