FDA 483 - Steriscience Specialties Private Limited - March 28, 2024

An FDA inspection of Steriscience Specialties Private Limited in Bengaluru, India, revealed significant deficiencies in quality control, manufacturing processes, and record-keeping. The firm released drug products containing rejected API, conducted inadequate investigations into product discrepancies and environmental excursions, and failed to properly train visual inspectors. These issues indicate a systemic lack of adherence to established quality standards for sterile drug manufacturing.