483
Asahi Kasei Finechem Co., Ltd.Asahi Kasei Finechem Co., Ltd. – FDA 483, Nov 14, 2025
Record Details
An FDA inspection of Asahi Kasei Finechem Co., Ltd. in Nobeoka, Japan, an API manufacturer, revealed a significant quality control issue. The firm failed to perform method validation studies on in-house developed test methods and method verification studies on USP methods used for finished product release testing. This deficiency compromises the firm's ability to ensure product quality and compliance with specifications.
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ID · 9195403b-6fee-4323-a607-c71d5c43e77d
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