UCB hit with Form 483 at Belgium drug product facility

Quality control issues have landed UCB Pharma a Form 483 following an inspection of its facilities in Braine-l’Alleud, Belgium.

UCB Pharma underwent an inspection of its manufacturing facilities in April, resulting in the issuance of a Form 483 by the regulatory authority. A Form 483 is a document used by the US Food and Drug Administration (FDA) to notify a company of observed deviations from Good Manufacturing Practices (GMP) during an inspection.

During the inspection, the FDA identified certain deviations relating to manufacturing practices that may impact the quality, safety, or efficacy of the pharmaceutical products being produced.

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Specifically, the firm failed to establish adequate document control within its Quality Unit and observed shredded paperwork without assurance that it did not contain quality documents.

A second observation criticized environmental and personnel monitoring and included an example of an employee’s upper body entering a restricted access barrier systems (RABS) for aseptic processing.

The third observation found UCB’s procedures inadequate to describe the handling and rejection of in-process materials.

Receiving a Form 483 is a significant event for any pharmaceutical company as it indicates areas of concern that need to be addressed promptly, though does not necessarily imply products are unsafe or ineffective. UCB is now responsible for reviewing the observations made by the FDA and formulating an appropriate response plan to address the identified deviations.

The site in Braine-l’Alleud comprises of 35 buildings serving UCB’s full biopharma offering. In March 2022, UCB began construction of a gene therapy and clinical manufacturing plant at a cost of more than €200 million ($213 million).