FDA 483 - ZYTO Technologies, Inc. - December 13, 2022

ZYTO Technologies, Inc. in Lindon, UT, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The observations primarily concern inadequate design controls, insufficient corrective and preventive actions, incomplete complaint investigations, and poor document control, many of which are repeat observations from a previous inspection. The firm also failed to adequately maintain device history records and ensure auditor independence.