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

A pre-approval inspection by the FDA was conducted at UCB Pharma SA, a drug product manufacturer in Braine-l'alleud, Belgium, from January 27 to February 4, 2022. This inspection supported a drug product application and encompassed critical areas such as Quality, Facility and Equipment, Production, Materials, Packaging and Labeling, and Laboratory Control Systems. The regulatory framework for this inspection involved assessing the firm's compliance with manufacturing standards.

The FDA issued a 4-item Form FDA 483, detailing several significant issues. These included a failure to establish adequate process controls to assure the identity, strength, quality, and purity of the manufactured drug product. Additionally, the inspection found a lack of control procedures to monitor manufacturing processes for variability in in-process materials and finished drug products. Other observations highlighted an inadequately designed utility and a facility that was not properly maintained.

As a consequence, the field recommendation is to withhold approval, pending the company's adequate response to these objectionable conditions. UCB Pharma SA is required to address these findings comprehensively for the application to proceed.