FDA 483 - MedImmune U.K. Limited - June 14, 2022

An FDA inspection of MedImmune UK Limited, a vaccine manufacturer in Liverpool, United Kingdom, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate qualification of critical reagents, deficient bacterial endotoxin testing procedures, failure to notify the license holder of a deviation impacting distributed drug product, and lack of validation for assigned expiry dates. These issues suggest a potential risk to product quality and patient safety.