FDA 483 - Catalent Belgium SA - August 19, 2022

An FDA inspection of Catalent Belgium SA, a finished drug product manufacturer in Brussels, revealed nine significant deficiencies. These observations highlight a broad range of issues impacting the firm's compliance with good manufacturing practices, including problems with aseptic processing, deviation investigations, process controls, equipment qualification, data integrity, design history files, purchasing controls, and internal quality audits. The findings indicate a need for comprehensive corrective actions across multiple quality system areas.