FDA 483 - Diacor, Inc - October 03, 2019

An FDA inspection of Elecsys, Inc. in West Valley City, UT, a medical device manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for design changes, a repeat observation from a previous inspection, and did not properly maintain device history records for its Zephyr XL Hoverboard device, showing out-of-range weight measurements. These findings indicate deficiencies in the firm's quality system and record-keeping practices.