Granules India subsidiary completes FDA PADE inspection with zero observations

Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, situated in Chantilly, Virginia, USA, has successfully concluded the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection. The inspection occurred at GPI from July 31 to August 3, 2023, with zero observations recorded.

Detailed Look at the Inspection Process

The recent inspection covered Granules’ PADE surveillance, including the receipt, evaluation, processing, and reporting system for the marketed drug products across the globe. Conducted specifically at Granules Pharmaceuticals Inc., this inspection ensures that the company maintains adherence to stringent regulatory standards.

A Continuing Success Story for Granules India

This inspection marks Granules India’s fourth FDA audit since March 2023, all of which ended with zero observations. Such consistency serves as an enduring testament to Granules India’s steadfast commitment to the highest level of patient safety and product quality.

Granules India Limited’s CEO expressed pride in this achievement, stating, “This is Granules India’s fourth FDA audit since March with zero observations – a testament to Granules India’s unwavering commitment to ensuring the highest level of patient safety and product quality.”

With these continuous successes in FDA audits, Granules India fortifies its reputation as a leader in pharmaceutical quality control, affirming its dedication to excellence and compliance with international standards.