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

An FDA inspection of MedImmune U.K. Limited, a biologic vaccine drug substance manufacturer in Liverpool, revealed significant deficiencies in quality control and documentation practices. Observations included inadequate deviation reporting and impact assessment, insufficient data for positive control qualification, and incomplete investigations into action level excursions. Additionally, batch records were found to be inadequately designed to capture critical verification steps for vaccine production.