Catalent Belgium SA – FDA EIR, Aug 19, 2022

An FDA inspection of Catalent Belgium SA, located in Brussels, took place from August 10 to August 19, 2022. This pre-announced, for-cause inspection evaluated the firm as a combination drug/device manufacturer, specifically covering sterile small volume parenteral drugs and injectable delivery devices. The regulatory framework for the inspection included compliance programs for Medical Device Premarket Approval and Postmarket Inspections, as well as Sterile Drug Process Inspections. The inspection resulted in nine observations documented on an FDA-483 form. Key issues identified included insufficient airflow velocity in critical manufacturing areas, inadequate investigation of deviations, and deficiencies in media fill procedures. Significant concerns were also raised regarding the inadequate qualification of production equipment, including integrity testers and climate-controlled chambers, along with insufficient equipment clean hold time studies and a lack of control over quality control instruments. Further violations involved failures to perform electronic data and audit trail reviews, lack of verification for completeness and restoration of backup electronic data, inadequate maintenance of device history files, deficient purchasing procedures, and the absence of internal quality audits for medical devices. The inspection concluded with an Official Action Indicated (OAI) classification, and the FDA recommended a regulatory meeting with the firm, alongside a withhold for a specific biosimilar product. Catalent Belgium SA acknowledged the observations and committed to corrective actions, promising a written response within fifteen working days.