FDA 483 - Torrent Pharmaceuticals Limited - March 18, 2019

Torrent Pharmaceuticals Limited, a drug product manufacturer in Bharuch, India, was cited for significant deficiencies in its quality control and production systems. The inspection revealed repeated failures in thoroughly investigating discrepancies, inadequate laboratory and production record retention, and incomplete investigations into out-of-specification results and batch failures. These issues indicate a systemic breakdown in maintaining proper documentation and quality oversight.