Samsung Biologics Co., Ltd. – FDA 483, Sep 10, 2019

An FDA inspection of Samsung Biologics Co., Ltd in Incheon, Republic of Korea, a drug substance manufacturer, identified several deficiencies. Observations included inadequate maintenance of utilities and equipment, insufficient written procedures for the transfer of QC materials, and a lack of proper review for employee training. These findings highlight areas requiring improvement in the firm's quality management system.