FDA 483 - Tokyo Chemical Industry Co Ltd - May 16, 2025

An FDA inspection of Tokyo Chemical Industry Co., Ltd. in Fukaya, Japan, a human API manufacturer, revealed significant deficiencies in laboratory control and quality systems. The firm failed to thoroughly investigate out-of-specification results, deviations, and customer complaints, lacking scientific evidence and proper documentation. Additionally, stability storage conditions for API samples were not consistently maintained, raising concerns about product quality and integrity.