FDA 483 - Samsung Biologics Co., Ltd. - November 01, 2019

An FDA inspection of Samsung Biologics Co. Ltd., a sterile pharmaceutical manufacturer in Incheon, Korea, revealed significant deficiencies in their quality system. The firm failed to properly record and justify deviations from written production and process control procedures. Specifically, "GMP Incidents" were closed without adequate investigation or corrective actions, and the system for identifying reoccurring deviations was found to be insufficient.