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

An FDA inspection of Catalent CTS, LLC in Kansas City, MO, revealed significant deficiencies in preventing microbiological contamination in non-sterile drug products. The firm failed to establish and follow appropriate written procedures, evidenced by multiple water leaks and associated filth in USP water systems, and inadequate microbial monitoring and speciation of isolates. These issues indicate a serious lack of control over environmental conditions and quality processes.