483
Samsung Biologics Co., Ltd.FDA 483 - Samsung Biologics Co., Ltd. - September 10, 2019
Record Details
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.
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ID · 77f6bf66-c495-4acb-9642-77c572ec02e0