FDA 483 - Societal CDMO Gainesville, LLC - November 19, 2024

An FDA inspection of Societal CDMO Gainesville, LLC in Gainesville, GA, revealed a significant deficiency in computer system controls. The firm's data integrity standard operating procedures were found inadequate, specifically lacking requirements for periodic audit trail reviews and clear frequencies for project audit trail reviews. This indicates a moderate severity issue related to data integrity and record management.