# FDA 483 - Catalent CTS, LLC - October 23, 2018

Source: https://www.keypedia.com/records/483/catalent-cts-llc/f0a4108f-c156-48cd-b380-4e63978fb25b

> FDA 483 for Catalent CTS, LLC on October 23, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent CTS, LLC
- Inspection Date: 2018-10-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Catalent CTS, LLC in Kansas City, MO, a drug manufacturer, was inspected by the FDA from October 15-23, 2018. The inspection revealed significant deficiencies in quality control, data integrity, and facility design, particularly concerning the manufacturing process and record-keeping for Selinexor 20mg tablets. Issues included inadequate investigation of discrepancies, insufficient computer system controls, and poor material flow design leading to potential contamination risks.

## Related Documents

- [483 - 2014-11-10](https://www.keypedia.com/records/483/catalent-cts-llc/5793ba1a-48e1-44ab-9e6e-522ce99e4293)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Investigator](https://www.keypedia.com/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)

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