UCB Pharma S.A.

FDA 483 - UCB Pharma S.A.

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Record Details

UCB Pharma S.A. in Braine-l'Alleud, Belgium, was inspected and cited for multiple deficiencies related to quality control and manufacturing processes. Observations included releasing products without sufficient stability data, inadequate visual inspection procedures, lack of scientific basis for stability and complaint evaluations, and insufficient quality oversight for contract manufacturers. The inspection revealed significant concerns regarding product quality, data integrity, and complaint handling.

Company: UCB Pharma S.A.
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Jacqueline M. Diaz Albertini (investigator)
Simone E. Pitts (National Expert, Pharmaceutical)

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ID · 7634bf8a-098c-4f65-869f-8b8dc49bf228