483
Nippon Kayaku Pharmatech Co., Ltd.Nippon Kayaku Pharmatech Co., Ltd. – FDA 483, Nov 25, 2022
Record Details
Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic manufacturing practices, including improper operator techniques and inadequate airflow studies. Additionally, the firm failed to properly qualify equipment and retain samples of active drug substances.
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ID · 5b637290-938f-4705-abff-d1e01c51ea03
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