FDA 483 - WAVi Co. - December 21, 2018

An FDA inspection of WAVI Co. in Englewood, CO, a manufacturer of the WAVI Headset medical device, revealed significant deficiencies in their quality management system. The firm failed to establish critical procedures for design validation, device master records, supplier evaluation, incoming product acceptance, training, and document control. Several corrective and preventative actions initiated by the firm remain open and overdue, indicating a systemic lack of compliance with quality system regulations.