UCB Pharma S.A. – FDA 483, Feb 4, 2022

An FDA inspection of UCB Pharma SA in Braine-l'Alleud, Belgium, identified significant deficiencies in process controls for drug product manufacturing, including issues with aseptic processing, visual inspection, and equipment cleaning. The firm also failed to ensure adequate utility design and facility maintenance. These observations indicate a lack of control over critical aspects of drug production and facility upkeep, potentially impacting product quality and sterility.