Loading…
NeuroSync, Inc. manufactured EYE-SYNC, a virtual reality headset and tablet computer used for eye assessments, but failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The company did not establish adequate design control procedures to verify that device design outputs met design input requirements, specifically failing to implement required design verification steps outlined in their own Design Controls and Software Design procedures, as evidenced by gaps in their eye tracking performance accuracy documentation. The violations were identified during an FDA inspection conducted from January 6 through February 5, 2025, and the company's February 27, 2025 response was found insufficient to address the inspectional observations.