FDA 483 - Reflexonic, LLC - September 24, 2025

An FDA inspection of Reflexonic, LLC in Leesburg, VA, a medical device specification developer, revealed significant deficiencies across its quality management system. The firm failed to establish adequate design controls, purchasing controls, complaint handling, and corrective and preventive action procedures. Additionally, the inspection found issues with device master records, organizational structure, quality audits, management reviews, and the implementation of Unique Device Identifier (UDI) requirements for its products.