Catalent Belgium SA – FDA EIR, Jun 19, 2019

Catalent Belgium SA, a contract manufacturer of sterile pre-filled syringes for global markets, underwent an FDA inspection from June 11 to June 19, 2019. This Level I inspection primarily focused on the company’s Quality, Facilities and Equipment, Production, and Laboratory Control Systems, with limited review of Materials and Packaging/Labeling Systems. The inspection identified three significant observations, documented on a Form FDA 483. Firstly, procedures to prevent microbiological contamination of sterile drug products were found inadequate. This included a lack of instructions for inspecting operator goggles for damage before use, as evidenced by an operator wearing compromised goggles during filling operations. Additionally, disinfectants used in critical areas were not prepared as sterile or filtered prior to use. Secondly, the company lacked adequate control procedures for monitoring manufacturing processes, specifically failing to qualify all operators performing semi-automatic visual inspection for various defects, including those affecting container closure integrity. Lastly, laboratory records were deemed deficient because blank forms for environmental monitoring and endotoxin testing could be printed at will by analysts without a tracking or reconciliation mechanism. These observations indicate deviations from regulatory standards. Management confirmed their intent to submit a written response to the FDA within 15 working days. The FDA advised that failure to address these issues could lead to enforcement actions, such as a Regulatory Meeting, Untitled Letter, Warning Letter, or Import Alert.