FDA 483 - Catalent Maryland Inc - April 28, 2025

Catalent Maryland, Inc. received an FDA Form 483 following an inspection conducted from April 22-28, 2025, at its Harmans, MD gene therapy manufacturing facility. The inspection highlighted several significant concerns regarding the firm's adherence to regulatory standards for drug product quality and control. Key observations included the absence of identity testing for incoming drug substances, which is critical for product integrity. Procedures for sterility release testing were found to be inadequate, specifically lacking specified timeframes for sample analysis. Furthermore, manufacturing equipment, such as peristaltic pumps used in critical processes, lacked proper qualification, routine maintenance, and calibration programs, raising questions about process control accuracy. The environmental monitoring program was deemed deficient, as viable surface sampling of ambidextrous gloves used during filling operations was not performed. The firm also had inadequate procedures for qualifying personnel involved in the visual inspection of drug product vials, with issues ranging from undefined defects to non-representative and poorly designed training/qualification kits. Finally, the inspection revealed a failure to follow established written procedures for records retention and retrieval, as a log of executed batch records could not be provided. Catalent is expected to respond to these observations with detailed corrective actions to ensure compliance with good manufacturing practices.