Cyber Medical Imaging Inc – FDA 483, Oct 31, 2022

Cyber Medical Imaging Inc. in Los Angeles, CA, a Class II medical device manufacturer, was inspected by the FDA from October 20-31, 2022. The inspection revealed one significant observation concerning inadequate validation of software used in their quality system. Specifically, software for finished device testing, complaint handling, customer services, and inventory controls was released without proper verification reports.