FDA 483 - Catalent Belgium SA - October 26, 2021

An FDA inspection of Catalent Belgium S.A. in Brussels, a drug product manufacturer, was conducted from October 18 to October 26, 2021. The inspection revealed significant deviations from current Good Manufacturing Practices (cGMP) affecting the quality and sterility of manufactured drug products. Key violations included a systemic failure to thoroughly investigate unexplained discrepancies, particularly regarding recurring HEPA filter failures in critical manufacturing environments and persistent environmental monitoring excursions. The company's risk classification for deviations was deemed inadequate, and effective corrective and preventive actions (CAPA) were not established. Furthermore, process validation for drug product manufacturing was insufficient, failing to prevent product contamination and ensure consistent quality. Sterilization validations were found to be deficient, lacking appropriate breach detection limits, adequate testing frequencies, and proper assessment of worst-case loads. Cleaning validation methods also showed weaknesses, omitting critical swab samples. The inspection also noted inadequate aseptic processing procedures, where sanitizing agents were sprayed in Grade A areas near exposed product without a proper risk assessment. Equipment and facilities exhibited poor maintenance, including damaged barrier systems, uninvestigated material contamination, faulty sink drainage, broken analytical equipment, and deteriorated surface sealants in GMP suites. Lastly, laboratory analytical methods for endotoxin testing lacked validation for sample storage, and several standard operating procedures were either deficient or not consistently followed, resulting in incomplete documentation. Catalent is required to address these observations by implementing robust corrective actions to ensure compliance with regulatory standards.