[Edaily Reporter KIM SAE-MI ] Innosys(056090)announced on the 5th that its “REGEN Hub,” a human tissue research and production facility in Seongnam, Gyeonggi Province, successfully completed an on-site inspection by the U.S. Food and Drug Administration (FDA) without any findings.

The inspection took place last September, and CG MedTech received the official inspection report (EIR) from the FDA on the 28th of last month. According to the company, the inspection results were reported as “No Observations,” and no specific corrective actions were requested on-site.

During this inspection, the FDA reviewed the management of raw human tissues—such as bone and skin—as well as the processing, storage, and distribution procedures, and the operation of the quality management system, in accordance with regulations governing human cells, tissues, and cell and tissue-based products (HCT/P).

Regen Hub is a production facility established by CG MedTech for its Contract Development and Manufacturing Organization (CDMO) business focused on human tissues. Last July, the company obtained a license amendment for a domestic tissue bank, thereby establishing a foundation for the processing and production of human tissues.

In June, CG MedTech signed a CDMO agreement with KOLON CORPORATION for the development, production, and supply of acellular allogeneic dermal products. The company is also expanding its client base by pursuing production and supply partnerships with Live Science for allogeneic dermal-based human tissue products.

Based on the results of this inspection, the company plans to enter the U.S. market and expand its global human tissue CDMO business. While pursuing exports of bone graft materials to the U.S., the company also intends to gradually expand its production system to meet customer demand.

Yoo Hyun-seung, CEO of CG MedTech, stated, “Completing this FDA inspection without any corrective actions is a significant achievement that demonstrates the human tissue manufacturing and quality control capabilities that Regen Hub has built up.” He added, “Moving forward, we will strengthen cooperation with our clients based on a stable production and supply system and expand our entry into overseas markets, including the U.S.”