FDA 483 - WAVi Co. - January 29, 2018

WAVI Co. in Englewood, CO, a manufacturer of the WAVI Headset and WAVi eSoc Single Use Electrode Contacts, was cited for numerous significant deficiencies across its quality system. The inspection revealed widespread issues with design controls, device master and history records, acceptance activities, equipment calibration, supplier management, document control, internal audits, and organizational structure. These observations indicate a fundamental lack of adherence to medical device quality system regulations.