483
Juzen Chemical CorporationFDA 483 - Juzen Chemical Corporation - August 01, 2025
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An FDA inspection of Juzen Chemical Corporation, an API manufacturer in Toyama, Japan, revealed significant issues with their manufacturing processes. The firm lacked a scientifically sound cleaning validation program and failed to adequately evaluate their water system for objectionable microorganisms. These observations indicate potential risks to product quality and safety.
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ID · 89034937-623c-4059-8a28-407d8076e47e