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

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.