FDA 483 - UCB Pharma SA, Braine - April 21, 2023

During an inspection conducted on April 17, 19, and 21, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to the inspected firm, citing several significant observations related to its manufacturing practices. The inspection revealed critical deficiencies in the company's quality management system, particularly concerning document control, environmental monitoring, and material handling procedures.

Key issues included a failure to establish adequate control over forms used for Good Manufacturing Practices (GMP) activities, such as in-process sample logs, facility cleaning records, and batch release checklists, leading to the use of uncontrolled blank forms. Furthermore, shredded material found on site raised concerns about the secure disposal of quality documents.

The FDA also noted inadequate environmental and personnel monitoring in classified areas, specifically highlighting insufficient swab sampling after syringe filling in Restricted Access Barrier Systems (RABS). Lastly, the firm's procedures for handling and rejecting in-process materials were found deficient. Its Standard Operating Procedures (SOPs) did not adequately address in-process material rejection, and discrepancies were observed between the physical labeling of rejected materials and their status in the firm's inventory system.

These observations, reported under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate conditions that require prompt attention to ensure compliance with regulatory standards and maintain product quality and safety.