FDA Cites Catalent Plant Over Water Leaks, Microbial Monitoring

FDA investigators have cited Catalent CTS for deficiencies in contamination prevention and microbial monitoring at its Kansas City, MO, drug manufacturing facility, including multiple water leaks and a failure to investigate a potentially objectionable microorganism detected in a manufacturing system. The findings were detailed in a just-posted Form FDA 483 issued 3/23 following an inspection.

According to the inspection report, investigators observed four water leaks involving facility water systems, including leaks that resulted in standing water and apparent filth on floors near equipment and tanks. FDA noted that drug products were being manufactured at the facility on the day some of the conditions were observed.

In one instance, company personnel acknowledged that a leak had been known before investigators identified it but could not provide documentation establishing when it was discovered.

FDA also cited Catalent for failing to follow written microbial monitoring procedures requiring further identification of organisms recovered from manufacturing systems.

The agency said an 8/2025 water sample yielded an organism identified as belonging to the Bacillus cereus/amyloliquefaciens/atrophaeus group. However, the company did not perform additional testing to determine whether the isolate was an objectionable microorganism and did not initiate an investigation.

The inspection document contained one observation addressing the company's failure to establish and follow adequate written procedures to prevent objectionable microorganisms in nonsterile drug products.