FDA 483 - Organ Eco Tech - February 27, 2020

Nuvexel Co. Ltd., a manufacturer of Class 2 spinal fixation systems in Seongnam-si, Korea, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, calibration, design review, and document control. These issues indicate a lack of robust controls over critical manufacturing and quality processes.