FDA 483 - MedImmune U.K. Limited - March 15, 2024

An FDA inspection of MedImmune U.K. Limited, a biologic vaccine drug substance manufacturer, was conducted from March 7-15, 2024. The inspection, carried out under the regulatory framework of Section 704(b) of the Federal Food, Drug and Cosmetic Act, identified several significant observations regarding the company's manufacturing and quality control processes. The primary issues included inadequate information and impact assessments within deviation reports, particularly concerning observed events, affected batches, and microbial impact. Investigators also noted a lack of sufficient data to support the qualification and stability of positive controls used in critical assays, as well as an absence of interference effect assessments. Furthermore, the firm failed to conduct adequate investigations into action level excursions, including the omission of formal deviation initiations and manual inspections of rejected materials. Finally, deficiencies were found in batch record design, specifically MABR-0009649 for flu vaccine monovalent bulk production, which did not capture all essential verification steps. MedImmune U.K. Limited is expected to provide a comprehensive response detailing corrective and preventive actions to address these findings and ensure compliance with regulatory standards.