# FDA 483 - Catalent CTS, LLC - November 10, 2014

Source: https://www.keypedia.com/records/483/catalent-cts-llc/5793ba1a-48e1-44ab-9e6e-522ce99e4293

> FDA 483 for Catalent CTS, LLC on November 10, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent CTS, LLC
- Inspection Date: 2014-11-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Catalent CTS (Kansas City), LLC identified significant deficiencies in the manufacturing and control of Lomitapide capsules. The firm failed to adequately validate analytical methods, establish proper control procedures for wet granulation, and maintain complete master batch records. Additionally, the company did not thoroughly investigate out-of-trend results, indicating a lack of robust quality oversight.

## Related Documents

- [483 - 2018-10-23](https://www.keypedia.com/records/483/catalent-cts-llc/f0a4108f-c156-48cd-b380-4e63978fb25b)

## Related Officers

- [Victoria A. Wagoner](https://www.keypedia.com/people/victoria-a-wagoner/3b26259b-4a87-485e-8fd5-b08aa87f6577)

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