RSI Technology Group, LLC – FDA 483, Apr 17, 2026

An FDA inspection of RSI Technology Group, LLC, a medical device specification developer and manufacturer, revealed significant deficiencies across its quality management system. The firm failed to adequately implement risk management, production controls, and design controls for its sterile products, ProteX and NovoSorT. These findings indicate a lack of adherence to established procedures and regulatory requirements, posing potential risks to product quality and patient safety.