483
Nippon Kayaku Pharmatech Co., Ltd.Nippon Kayaku Pharmatech Co., Ltd. – FDA 483, Sep 4, 2026
Record Details
Fuji Yakuhin Co., Ltd. in Toyama, Japan, a sterile drug manufacturing facility, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant failures in following aseptic processing procedures, inadequate validation of aseptic processes, and incomplete equipment cleaning and sanitization. Additionally, the firm's quality control laboratory was found to have issues with data integrity related to chromatographic analysis.
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ID · 60801a44-3868-42f1-9f09-f58cc11cbdce
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