FDA 483 - AstraZeneca Nijmegen B.V. - September 19, 2019

An FDA inspection of MedImmune Pharma BV in Nijmegen, The Netherlands, revealed two significant observations related to drug product manufacturing. The firm was cited for inadequate deviation investigations, specifically regarding failed HEPA filters without a proper product impact assessment. Additionally, operators failed to follow procedures designed to prevent microbiological contamination of sterile drug products, exhibiting poor aseptic technique.