FDA 483 - Societal CDMO Gainesville, LLC - February 27, 2026

Societal CDMO Gainesville, LLC, a manufacturer of prescription solid oral drugs, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in production and process controls, including inadequate written procedures and issues with blend uniformity. Additionally, the firm failed to thoroughly review unexplained discrepancies and exhibited inadequate controls over computer systems, including shared access and excessive operator privileges.