FDA 483 - UCB Pharma S.A. - April 21, 2023

UCB Pharma SA in Braine, Belgium, was inspected for drug product manufacturing, revealing significant deficiencies. The firm failed to establish adequate document control for GMP activities, including the use of uncontrolled forms and concerns about shredded quality documents. Additionally, environmental and personnel monitoring in classified areas were found to be inadequate, and procedures for handling and rejecting in-process materials were insufficient.