FDA 483 - Reliance Medical Systems LLC - November 17, 2022

Reliance Medical Systems LLC, a medical device manufacturer in Bountiful, UT, received a Form FDA 483 with three observations following an inspection. The firm was cited for significant deficiencies including inadequate maintenance of device history records, insufficient documentation and verification of corrective and preventive actions, and a lack of independence for quality audit personnel. These findings indicate a need for substantial improvements in their quality management system.