FDA inspection of UCB facility in Belgium finds several quality issues
UCB, a Brussels-based biopharmaceutical company, had several issues cited by FDA inspectors at a manufacturing facility in Belgium, but the company is not panicking.
According to a 483 report, the FDA inspected UCB’s manufacturing facility in Braine-l’Alleud, Belgium, between April 17 and 21 of this year, with inspectors finding three significant observations.
The FDA found issues with the quality unit at the facility surrounding its control of documents. The report said that UCB had “uncontrolled” logs recording cleaning activities in classified areas, among other examples of “uncontrolled” logs being used. Inspectors also found shredded documents at the facility but had no assurance that the materials did not contain quality documents.
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