FDA 483 - Catalent Maryland Inc - March 10, 2023

Catalent Maryland, Inc., a drug substance manufacturer in Harmans, MD, underwent an FDA inspection from March 6-10, 2023. The inspection concluded with the issuance of a Form FDA 483, detailing significant observations related to the firm's quality management system and procedural adherence. The primary issues identified were twofold. First, the Quality Unit demonstrated a failure to ensure the integrity and effectiveness of its Quality Management System. This was evidenced by change controls that lacked scientific justification and sufficient impact analysis, not conforming to established standard operating procedures. A specific instance involved the release of a drug substance lot prepared with an unapproved process change, where the corresponding change control was not approved by the Quality Unit beforehand. Second, the Quality Unit also failed to properly address issues that could impact product quality. This included non-compliance with the company's Standard Operating Procedure for Deviations, which mandates specific documentation. For example, a recent Deviation Report was approved despite omitting critical information agreed upon by the Quality Unit and subject matter experts. These observations, issued under the regulatory framework of the Federal Food, Drug and Cosmetic Act, necessitate a prompt response. Catalent Maryland, Inc. is required to address these findings by providing a comprehensive plan of corrective and preventive actions to ensure compliance with regulatory standards and internal procedures.