FDA 483 - Samsung Biologics Co., Ltd. - June 09, 2022

Samsung Biologics Co., Ltd. in Incheon, Korea, was cited for significant deficiencies in quality control and aseptic processing during an FDA inspection. Observations included an unreliable endotoxin detection method, inadequate cleaning procedures for RABS, and insufficient investigations into high invalid assay rates for critical product testing. These issues indicate a lack of robust quality systems and control over manufacturing processes.