FDA 483 - Tokyo Chemical Industry Co Ltd - May 16, 2025
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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.
ID · 3079e976-91f3-4144-9070-4be3427b0075