FDA 483 - Samsung Biologics Co., Ltd. - February 20, 2023

An FDA inspection of Samsung Biologics Co., Ltd. in Yeonsu-gu, Incheon, Republic of Korea, revealed significant deficiencies in their quality control unit, including data integrity violations and incomplete investigations. The inspection also cited issues with the requalification of reference standards and inadequate control over incoming final containers. These findings indicate a lack of robust quality system oversight.