FDA 483 - Watson Pharma Private Limited - May 20, 2025

Watson Pharma Private Limited, a drug product manufacturer in Verna, India, was inspected by the FDA from May 12-20, 2025. The inspection revealed significant deficiencies in cross-contamination controls for shared manufacturing equipment, inadequate investigations into unexplained discrepancies and out-of-specification results, and a lack of established control procedures for manufacturing processes, particularly regarding visual inspection and defect recording. These issues indicate a failure to ensure drug product quality and consistency.