FDA 483 - Eyegaze Inc. - May 02, 2025

An FDA inspection of Eyegaze Inc. in Fairfax, VA, a medical device manufacturer, revealed significant deficiencies in quality system procedures. The firm was cited for inadequate control of nonconforming products, improper Unique Device Identifier (UDI) labeling on its medical devices, and a complete lack of procedures for controlling labeling activities. These issues indicate a need for comprehensive improvements in their quality management system.