FDA 483 - UCB Pharma S.A. - February 04, 2022

An FDA Form 483 inspection of a drug product manufacturing facility revealed several deficiencies.

**Observation 1** details a failure to establish adequate process controls. During the manufacture of Lot (b)(4) on January 31, 2022, fill (b)(4) was observed dripping on the restrictive access barrier (RAB) fill line (b)(4) in static mode, requiring wiping with a sterile (b)(4) wipe. In dynamic mode, product droplets were frequently observed at fill (b)(4) tips. There was no quality assessment of the sterile (b)(4) use or its impact on drug product quality, indicating the filling process was not controlled to prevent contamination. Additionally, the sanitization of critical surfaces was found to be justified based on inadequate aseptic technique, and personnel exhibited inadequate gowning (exposed skin) during RAB fill line setup and manufacturing for Lot (b)(4). The facility also lacked media fill procedural requirements or validation to evaluate the sterile hold time of (b)(4) for filling machine setup equipment.

**Observation 2** highlights a lack of established control procedures to monitor manufacturing processes. SOP-ai-101286, "Processes de qualification au mirage," v4, allows for the discard of rejected drug product units with particles without QA/QC oversight or investigation unless an overall reject limit is exceeded. Visual inspectors are not trained on the criticality of extrinsic particles, and no procedure defines