FDA 483 - STgen Bio Co., Ltd. - June 25, 2024

STgen Bio Co., Ltd., a drug substance and drug manufacturer in Incheon, Republic of Korea, was inspected by the FDA from June 17-25, 2024. The inspection revealed significant deficiencies across multiple areas, including aseptic processing, environmental monitoring, visual inspection of sterile products, quality unit responsibilities, laboratory controls, and adherence to standard operating procedures. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and purity.