Catalent Indiana, LLC – FDA 483, Nov 15, 2023

An FDA inspection of Catalent Indiana, LLC, conducted from October 31 to November 15, 2023, identified critical deficiencies across its manufacturing operations, resulting in a Form FDA 483. Key violations primarily involve the quality control unit's inadequate oversight, failing to ensure thorough investigations into errors, proper process validation, qualified personnel for visual inspection, and equipment maintenance. A significant issue was the firm's failure to comprehensively review unexplained discrepancies and batch failures, including numerous deviations for equipment malfunctions and particle contamination in drug products, often without definitive root causes. The company also demonstrated inadequate procedures to prevent microbiological contamination of sterile drug products. This included insufficient validation of aseptic processes, incomplete airflow visualization studies, lapses in operator aseptic technique, stained equipment, and improper material handling. Further observations noted inadequate qualification methods for visual inspection, unvalidated endotoxin sample storage, and a failure to adhere to written procedures for equipment cleaning and maintenance. Catalent Indiana, LLC must now develop and implement robust corrective actions to address these observations and ensure full compliance with current regulatory manufacturing standards.