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

An FDA inspection of Samsung Biologics Co., Ltd.'s drug substance and drug product manufacturing facility in Incheon, Republic of Korea, was conducted from July 22 to July 30, 2024. This risk-based inspection, guided by applicable FDA Good Manufacturing Practice (GMP) regulations and ICH Q7, identified eight significant observations. Main issues included inadequate procedures to prevent microbiological contamination of sterile drug products, insufficient investigation of unexplained discrepancies, and deficiencies in written production and process controls. The inspection also noted a lack of adequate procedural controls for electronic data systems, insufficient assurance of contamination prevention in manufacturing, high rates of system suitability test failures in laboratory controls, and incomplete validation of production bioreactors. Furthermore, the company showed inadequate adherence to or establishment of standard operating procedures. Samsung Biologics management has committed to providing a written response to these observations within 15 business days, detailing corrective actions to address the identified regulatory non-compliance.