FDA 483 - Torrent Pharmaceuticals Limited - September 28, 2022

An FDA inspection of Torrent Pharmaceuticals Limited in Indrad, Gujarat, India, revealed significant deficiencies in equipment cleaning and maintenance, quality control investigations, and drug complaint handling. Observations included inadequate cleaning procedures leading to product cross-contamination, a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification results, and deficient investigations into product quality complaints. These issues indicate a lack of robust quality systems to ensure drug product safety, identity, strength, quality, and purity.