FDA 483 - Samsung Biologics Co., Ltd.

Samsung Biologics Corporation, Ltd. in Yeonsu-Gu, Incheon, Republic of Korea, was cited with five observations during an FDA inspection. The inspection revealed significant issues related to aseptic processing, including microbial contamination risks, inadequate quality control oversight, failure to record deviations, poor equipment maintenance, and deficiencies in environmental monitoring. These findings indicate a lack of adherence to GMP procedures for sterile drug product manufacturing.