FDA 483 - Torrent Pharmaceuticals Limited - May 25, 2023

An FDA inspection of Torrent Pharmaceuticals Limited in Bharuch, Gujarat, India, revealed significant deficiencies in their manufacturing processes. The firm failed to thoroughly investigate unexplained discrepancies, establish scientifically justified root causes for deviations, and extend investigations to potentially impacted batches. Additionally, inadequate controls over computerized systems for record-keeping were observed, indicating a lack of data integrity.