FDA 483 - Samsung Biologics Co., Ltd. - August 24, 2021

Samsung Biologics Co., Ltd., a drug substance manufacturer in Incheon, Republic of Korea, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in cleaning validation processes, specifically regarding cross-contamination assessments and dirty hold time studies. Additionally, the firm failed to adequately investigate discrepancies to identify root causes and implement effective corrective actions, as evidenced by issues with mold detection and bioburden testing procedures.