FDA 483 - Zynex Medical, Inc - June 15, 2022

An FDA inspection of Zynex Medical, Inc. in Englewood, CO, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for corrective and preventive actions, rework of nonconforming products, acceptance of incoming products, and internal quality audits. These issues suggest a need for comprehensive improvements in the firm's quality management processes.