FDA EIR - Catalent Maryland Inc - March 10, 2023

An FDA Pre-Approval Inspection of Catalent Maryland, Inc., located in Harmans, MD, was conducted from March 6-10, 2023. The inspection aimed to support a Biologics License Application for delandistrogene moxeparvovec, a gene therapy product, under the regulatory framework of Compliance Program Guidance Manual-45 for Biological Drug Products. The inspection resulted in the issuance of an FDA Form-483 with two observations. The primary concern was the Quality Unit's failure to ensure the integrity and effectiveness of the Quality Management System, potentially impacting product integrity. Specific issues included environmental monitoring trend reports lacking identified corrective and preventive actions (CAPAs), which deviated from the company's standard operating procedures. Additionally, a batch production record for SRP-9001 Drug Substance was approved despite an associated change control remaining open, contrary to established batch release procedures. While their investigations were deemed acceptable, prior critical deviations involving cross-contamination of product samples with a viral vector from another client were noted, underscoring vulnerabilities within the quality system. Inspectors also observed weaknesses in material control, such as unsecured access to drug substance key lockboxes and a lack of specific procedures for temperature-controlled material locations. Catalent Maryland, Inc. is required to address these observations and submit a formal response to the FDA, detailing corrective actions. The firm has already implemented CAPAs for the prior cross-contamination incidents, including decontamination and segregation measures, with an effectiveness check scheduled for April 2023.