FDA 483 - Fuji Yakuhin Co., Ltd. - November 25, 2022

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.