# FDA 483 - Jayhawk Fine Chemicals Corporation - July 24, 2025

Source: https://www.keypedia.com/records/483/jayhawk-fine-chemicals-corporation/a5ced7f1-f2b6-4193-91f3-1f79a7750b34

> FDA 483 for Jayhawk Fine Chemicals Corporation on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jayhawk Fine Chemicals Corporation
- Inspection Date: 2025-07-24
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Jayhawk Fine Chemicals Corporation in Galena, Kansas, revealed significant deficiencies in their manufacturing processes. The firm failed to adequately document and test process water used in non-sterile API production and equipment cleaning, lacking a risk-based analysis for its suitability. Additionally, Quality Assurance did not properly investigate a cleaning validation failure or establish a root cause.

## Related Officers

- [Claudia G Perez-Kozlowski](https://www.keypedia.com/people/claudia-g-perez-kozlowski/edb224b9-fecf-4ece-9964-4fb76f259fe6)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/jayhawk-fine-chemicals-corporation/03ba2a14-9024-4c06-b1a1-439d2b60c729

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79