FDA 483 - Catalent Indiana, LLC - April 13, 2026

Catalent Indiana LLC received a Form 483 for significant deficiencies in its manufacturing of sterile drug products. The inspection revealed recurring issues with extrinsic particulate contamination, inadequate investigations into batch failures and water intrusion events, and deficiencies in aseptic processing controls. The firm also failed to establish robust visual inspection methods, environmental monitoring, and quality unit procedures, indicating a systemic lack of control over critical manufacturing processes.