FDA 483 - Samsung Biologics Co., Ltd. - July 25, 2017

An FDA inspection of Samsung BioLogics' drug substance manufacturing facility in Yeonsu-gu, Incheon, Korea, revealed significant deficiencies in laboratory controls, deviation investigations, and microbial control. The firm failed to adequately verify test methods, properly investigate deviations, ensure microbial control procedures, and conform to USP-NF standards for critical raw materials. These issues indicate a lack of scientifically sound and appropriate procedures to assure product quality and purity.