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