FDA 483 - Centrient Pharmaceuticals India Private Limited

DSM Sinochem Pharmaceuticals India Private Limited, a drug substance manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate control of reprocessed materials leading to API contamination, failure of the quality unit to reject out-of-specification APIs, and incomplete batch production records. Additionally, the firm lacked proper validation for reprocessing methods and maintained insufficient laboratory control mechanisms, indicating a systemic breakdown in ensuring product quality and data integrity.