FDA 483 - RSI Technology Group, LLC - February 22, 2023

RSI Technology Group, LLC, a device manufacturer in Dallas, TX, was inspected and cited for significant deficiencies in its quality system. Observations included failures to conduct management reviews and quality audits at defined intervals, lack of document change records, and absence of established design control procedures for its Class II device, ProteX. Additionally, the firm was found non-compliant with Unique Device Identification requirements for its ProteX device.