FDA 483 - Samsung Biologics Co., Ltd. - March 14, 2018

An FDA inspection of Samsung Biologics in Incheon, Republic of Korea, identified significant deficiencies in quality assurance oversight and pest control. The firm lacked adequate risk assessment for drug substance intermediates, improperly stored micro testing media, and inadvertently discarded critical bioburden samples. Additionally, the pest control program was deemed inadequate due to variable alert and action limits.