NeuroSync, Inc. – FDA Warning Letter, Feb 5, 2025

On May 9, 2025, the FDA issued a Warning Letter to a firm in Holliston, MA, following an inspection from January 6 to February 5, 2025. The firm manufactures EYE-SYNC, a virtual reality headset and tablet for eye assessments, classified as a medical device. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: * Failure to verify device design against input requirements (21 CFR 820.30(f)), e.g., EYE-SYNC accuracy requirement not met, and lack of testing for data quality warnings. * Failure to identify, document, validate, verify, review, and approve design changes before implementation (21 CFR 820.30(i)), e.g., software correction not verified. * Failure to establish appropriate design inputs (21 CFR 820.30(c)), e.g., outdated requirements in design input documents. * Failure to validate device design to user needs (21 CFR 820.30