FDA 483 - WAVi Co. - March 31, 2022

WAVi Co. in Denver, CO, a medical device manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, insufficient process controls for headset production, and a lack of established statistical techniques for design verification. Additionally, the firm failed to appoint a management representative to oversee quality system requirements.