FDA 483 - Elite Performance and Learning Center, PS - May 14, 2019

Elite Performance and Learning Center, PS, a manufacturer of the Zone-Trac mobile biofeedback device in Seattle, WA, was inspected by the FDA. The inspection revealed a severe lack of fundamental quality system procedures, with the firm failing to establish written procedures for medical device reporting, complaint handling, design control, CAPA, document control, calibration, purchasing, and servicing. This indicates a pervasive absence of basic operational controls required for medical device manufacturing.