FDA 483 - Pyrexar Medical, Inc. - May 18, 2022

An FDA inspection of Pyrexar Medical, Inc. in West Valley City, UT, from May 9-18, 2022, revealed a significant quality system deficiency regarding complaint handling. The firm failed to properly investigate customer complaints or document justifications for not investigating them, as required by their procedures. This indicates a breakdown in their complaint management process for medical devices.