FDA 483 - ZYTO Technologies, Inc. - June 06, 2024

ZYTO Technologies, Inc. in Pleasant Grove, UT, was inspected and cited for significant quality system deficiencies, many of which are repeat observations. The inspection revealed failures in design control, corrective and preventive action procedures, document control, and software validation for electronic records. These issues indicate a systemic lack of adherence to quality system requirements for their Class II Hand Cradle GSR Device.