FDA 483 - Samsung Biologics Co., Ltd. - July 30, 2024

Samsung Biologics Co., Ltd. in Incheon, Republic of Korea, received a Form 483 citing significant deficiencies in its drug substance and drug product manufacturing. Observations included inadequate aseptic processing controls, poor investigation practices for deviations and environmental monitoring excursions, and insufficient data integrity controls for electronic systems. The firm also faces concerns regarding cleaning validation, high rates of laboratory system suitability test failures, and incomplete bioreactor validation.