UCB Pharma, a Belgium-based biopharma company, has been slapped with a Form 483 from the FDA following an inspection that uncovered issues with its quality control unit and product storage.
The notice by the U.S. regulatory agency followed an April inspection of the company's facility in Braine-l'Alleud, Belgium. The FDA cited UCB with three observations as a result of the inspection.
Inspectors said the quality unit at the facility “failed to establish adequate document control” of forms used in GMP production. For instance, staffers shredded some paperwork without assurance they “did not contain quality documents,” the FDA said.
Additionally, the company was cited for inadequate environmental and personnel monitoring in classified areas and for lacking proper procedures in the handling and rejection of in-process materials.
Inspectors also found materials in a warehouse that were stored in a locked cage labeled as “rejected” although the company’s records had them labeled as having “quarantined” status.
This isn't UCB's first manufacturing-related setback at the FDA lately. Last year, the company's psoriasis prospect bimekizumab received an FDA rejection because of the agency's inability to inspect European facilities due to COVID-related travel restrictions.
However, in late December, the agency accepted UCB’s biologics license application resubmission and awarded the drug a six-month review period.
“UCB can confirm all bimekizumab-related FDA manufacturing observations have been addressed," a spokesperson said via email. "There are no open or outstanding information requests, topics, or questions with FDA."
The company expects the FDA to make an approval decision on bimekizumab by the end of the second quarter of 2023.
Editor's note: This story was updated on Wednesday, May 31, with a statement from UCB.