# FDA WARNING_LETTER - NeuroSync, Inc. - February 05, 2025

Source: https://www.keypedia.com/records/warning_letter/neurosync-inc/407f9de3-8676-477c-b52a-7f678fd90b43

> FDA WARNING_LETTER for NeuroSync, Inc. on February 05, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: NeuroSync, Inc.
- Inspection Date: 2025-02-05
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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    *   Failure to establish appropriate design inputs (21 CFR 820.30(c)), e.g., outdated requirements in design input documents.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

## Related Documents

- [483 - 2025-02-05](https://www.keypedia.com/records/483/neurosync-inc/05f308c5-28ab-434b-a06e-013d40247de8)

## Related Officers

- [Matthew G. Hillebrenner](https://www.keypedia.com/people/matthew-g-hillebrenner/e076699e-8da2-4223-a114-b33339bdf225)

Company: https://www.keypedia.com/companies/neurosync-inc/e2eeae43-a0cd-41b7-b6bf-7e4e86628202

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7