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

Source: https://www.keypedia.com/records/483/catalent-cts-llc/d4b76e88-3692-4b04-b3d6-e40964458e09

> FDA 483 for Catalent CTS, LLC on March 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent CTS, LLC
- Inspection Date: 2026-03-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2014-11-10](https://www.keypedia.com/records/483/catalent-cts-llc/5793ba1a-48e1-44ab-9e6e-522ce99e4293)
- [483 - 2018-10-23](https://www.keypedia.com/records/483/catalent-cts-llc/f0a4108f-c156-48cd-b380-4e63978fb25b)
- [483 - 2026-03-23](https://www.keypedia.com/records/483/catalent-cts-llc/e035ad86-1c8c-497f-9708-ef17567cf7f4)

## Related Officers

- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [Kelly M. Bromley](https://www.keypedia.com/people/kelly-m-bromley/964704be-b203-4c56-b1d7-6144e9e0236e)

Company: https://www.keypedia.com/companies/catalent-cts-llc/db17ec22-68a4-42be-86e9-4c1410a493a8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8