FDA 483 - SmartGuard Rx, Inc. - December 12, 2018

SmartGuard Rx, Inc. in Layton, UT, a medical device specification developer, was inspected by the FDA from December 10-12, 2018. The inspection revealed significant deficiencies across multiple quality system areas, including a complete lack of established procedures for MDRs, complaint handling, supplier evaluation, design control, document control, nonconforming product, quality audits, and management review. These findings indicate a fundamental absence of a robust quality system for the SmartGuard Elite device.