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

MedImmune UK Limited, a vaccine manufacturer in Liverpool, United Kingdom, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate qualification of critical reagents, deficient bacterial endotoxin testing procedures, failure to notify the license holder of a deviation impacting product quality, and a lack of validation for assigned expiry dates of sterile materials. These issues indicate potential risks to product quality and regulatory compliance.