FDA 483 - Catalent Greenville Inc - October 24, 2025

The FDA inspected Catalent Greenville Inc, a contract drug manufacturer, and issued a Form 483 with three observations. The inspection revealed significant issues across equipment maintenance, microbial testing, and stability program adherence, indicating potential risks to drug product quality and safety. Specifically, observations included unvalidated equipment modifications, worn equipment, inadequate microbial testing and identification, and poor control over stability samples.