The FDA issued a Form 483 to UCB Pharma, a biopharma business with headquarters in Belgium after an examination revealed problems with its quality control unit and product storage.

The U.S. regulatory body issued the warning after inspecting the business's Braine-l'Alleud, Belgium, in April. As a consequence of the examination, the FDA issued UCB three observations.

Inspectors found that the facility's quality unit "failed to establish adequate document control" of the GMP production forms. For instance, staff members destroyed certain documentation without confirming it "did not contain quality documents," according to the FDA.

Inspectors also discovered goods in a warehouse that were recorded in the company's records as having "quarantined" status but were kept in a closed cage with the label "rejected" and were stored there instead.

The company was also criticised for missing appropriate processes for the handling and rejection of in-process materials as well as for insufficient environmental and staff monitoring in restricted areas.

This FDA setback is not UCB's first recent manufacturing-related issue. The FDA rejected the company's psoriasis drug candidate bimekizumab last year because it was unable to audit European facilities because of COVID-related travel limitations.

However, in late December, the organisation approved UCB's resubmission of its biologics license application, and the medicine was given a six-month review period.