FDA 483 - Torrent Pharmaceuticals Limited - December 11, 2023

An FDA inspection of Torrent Pharmaceuticals Limited in Chhatral, Gujarat, India, revealed significant deficiencies across quality control, equipment management, and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results, lacked proper qualification and maintenance for equipment, and did not adequately validate test methods. These issues indicate a compromised quality system that could impact the safety and quality of drug products.