FDA EIR - Catalent Pharma Solutions, LLC - July 13, 2018

An FDA inspection of Catalent, Inc. at its Somerset, NJ facility occurred from July 11-13, 2018. The inspection focused on compliance with Post-marketing Adverse Drug Experience (PADE) Reporting Regulations. Although the inspection concluded with "No Action Indicated" and no FDA Form 483 was issued, several issues were discussed with management. Key observations included the late submission of an expedited Individual Case Safety Report (ICSR CAT-000162-2016) to the FDA, which was 42 days overdue. Furthermore, one safety exchange agreement with a customer was deemed inadequate as it lacked specific timeframes for exchanging adverse drug experience information. The inspection also noted the absence of a dedicated Standard Operating Procedure for handling adverse drug experiences received by the legal department, despite employees receiving training. Some employees were identified as needing refresher training for adverse event procedures, and internal record retention policies required review to ensure full FDA compliance. Catalent management committed to addressing these observations, pledging to promptly amend the inadequate safety exchange agreement, ensure timely submission of future ICSRs, and review record retention procedures for compliance. This inspection highlighted areas for improvement in pharmacovigilance processes, despite no significant regulatory action being required.