FDA 483 - Catalent CTS, LLC - March 23, 2026

Candent CTS, LLC in Kansas City, MO, a drug manufacturer, was cited for failing to establish and follow appropriate written procedures to prevent objectionable microorganisms in non-sterile drug products. The inspection revealed multiple water leaks and associated filth in the facility's water systems, as well as a failure to properly identify microbial isolates recovered from these systems to the species level. This indicates significant issues with environmental control and microbial monitoring, posing a risk to drug product quality.