FDA EIR - Catalent Maryland Inc - March 10, 2023

An FDA Pre-Approval Inspection was conducted at Catalent Maryland, Inc. in Harmans, MD, from March 6-10, 2023. This inspection supported a Biologics License Application for delandistrogene moxeparvovec, a gene therapy product. The regulatory framework for this inspection followed the Compliance Program Guidance Manual-45 for Biological Drug Products, specifically for Human Cell and Gene Therapies.The inspection identified two significant issues, documented in an FDA Form-483. Firstly, the company's Quality Unit did not adequately ensure the integrity and effectiveness of its Quality Management System. This was exemplified by environmental monitoring trend reports that failed to include identified corrective and preventive actions, contrary to established procedures. Secondly, a batch record for the SRP-9001 Drug Substance Lot was approved while a corresponding change control remained open, which deviated from the firm's own documented batch release requirements.These observations highlight deficiencies in the firm's quality system oversight and adherence to internal procedures. Catalent Maryland, Inc. is required to formally respond to these findings, outlining comprehensive corrective actions to address the identified issues, reinforce the integrity of their quality management system, and prevent recurrence to ensure product quality and safety.