FDA 483 - Catalent Belgium SA - October 26, 2021

Catalent Belgium S.A. received an FDA Form 483 following an inspection of their Brussels drug product manufacturing facility from October 18 to 26, 2021. The inspection revealed multiple observations indicating deficiencies in adherence to Current Good Manufacturing Practices (cGMP). Key violations included a recurring failure to thoroughly investigate unexplained discrepancies, specifically numerous HEPA filter failures in critical manufacturing environments and persistent environmental monitoring excursions across various cleanroom grades. The company's risk assessments and corrective actions for these issues were found to be inadequate. Additionally, significant concerns were raised regarding insufficient validation of critical processes, including a drug product manufacturing process that exhibited visible contamination, and validations for preventing microbial contamination, such as integrity testing for critical equipment, sterilization parameters, and cleaning procedures.

Further observations highlighted inadequate written procedures for aseptic processing, with sanitizing agents improperly used near exposed product components. The facility's equipment and infrastructure displayed maintenance shortcomings, including damaged barrier systems, unexplained residues on machinery, and deteriorated surface finishes in GMP suites. The laboratory's endotoxin analytical method lacked proper validation for sample storage, and several standard operating procedures were either incomplete or not consistently followed by personnel. Catalent Belgium S.A. is required to address these observations by implementing robust corrective and preventive actions to ensure product quality and compliance.