Inspection Record

UCB Pharma SA, Braine — FDA 483 Findings

US FDAInspected 2023-04-21Published 2023-05-25 3 findingsQuality unit oversightMaterial and supplier controlTraining and personnel

View the regulator's official source The source document is always the basis for judgement.

Findings

1Quality unit oversight

Your Quality Unit failed to establish adequate document control of the forms that are used for GMP activities.

2Material and supplier control

Your procedures are inadequate to describe the handling and rejection of in-process materials.

3Training and personnel

The environmental and personnel monitoring are inadequate in classified areas.

About this record

Extracted automatically from the document US FDA published on 2023-05-25. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

UCB Pharma SA, Braine company profile — full history US FDA documents, 2023 Go to Findings search