UCB Pharma S.A. – FDA EIR, Apr 21, 2023

An FDA inspection of UCB Pharma S.A., a drug product manufacturer located in Braine-L'Alleud, Belgium, took place from April 17 to April 21, 2023. This risk-based inspection specifically evaluated processes related to drug product manufacture, including filling, de-packaging, and packaging. The regulatory framework for the inspection incorporated FDA guidances such as 'Medical Devices with Sharps Injury Prevention Features' (FDA-2020-D-0957) and 'Delivering Drug and Biological Products' (FDA-2013-D-0362). At the conclusion of the inspection, a Form FDA 483 was issued to UCB Pharma S.A. The issuance of this form signifies that observations of objectionable conditions or practices were noted by the FDA investigator. While the specific details of these observations are not included in this document, such findings typically relate to potential deviations from Current Good Manufacturing Practice (CGMP) regulations. Consequently, UCB Pharma S.A. is required to provide a formal written response to the FDA, outlining its comprehensive plan of corrective and preventive actions to address each identified observation. The inspection report was subsequently referred to the Center for Drug Evaluation and Research (CDER) for further review and decision-making.