FDA 483 - Kaneka Corporation Takasago Plant - October 13, 2023

Kaneka Corporation Takasago Plant, an API and Intermediate Manufacturer in Takasago, Hyogo, Japan, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including contamination controls, out-of-specification investigations, analytical method validation, CAPA procedures, reserve sample examination, and water system pathogen evaluation. These issues indicate a moderate to severe level of non-compliance with good manufacturing practices.