FDA 483 - Samsung Biologics Co., Ltd.

Samsung BioLogics Co., Ltd. in Incheon, Republic of Korea, was inspected for drug substance and drug product manufacturing, revealing significant deficiencies across multiple areas. Issues included compromised HEPA filter integrity, inadequate aseptic techniques, and deficiencies in environmental monitoring and equipment maintenance. Furthermore, the firm exhibited poor control over deviations, CAPA effectiveness, laboratory testing procedures, and process monitoring, indicating a systemic lack of assurance in product quality and compliance.