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

Societal CDMO Gainesville, LLC, a manufacturer of prescription solid oral drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate production and process controls for drug product quality, failure to thoroughly review unexplained discrepancies in blend uniformity, and insufficient controls over computer systems for master production records. These issues collectively indicate a lack of robust quality assurance and control over critical manufacturing processes.