# FDA 483 - NeuroSync, Inc. - February 05, 2025

Source: https://www.keypedia.com/records/483/neurosync-inc/05f308c5-28ab-434b-a06e-013d40247de8

> FDA 483 for NeuroSync, Inc. on February 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroSync, Inc.
- Inspection Date: 2025-02-05
- Product Type: device
- Office Name: New England District Office
- Summary: NeuroSync, Inc. in Holliston, MA, a medical device manufacturer, received a Form FDA 483 with 12 observations during an inspection from January 6 to February 5, 2025. The observations highlight significant deficiencies across multiple quality system areas, including design controls, CAPA procedures, complaint handling, UDI requirements, purchasing controls, risk analysis, and device history records. Several issues, such as design output, CAPA, complaint handling, and purchasing/supplier monitoring, were noted as repeat concerns from previous inspections, indicating systemic problems.

## Related Documents

- [WARNING_LETTER - 2025-02-05](https://www.keypedia.com/records/warning_letter/neurosync-inc/407f9de3-8676-477c-b52a-7f678fd90b43)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144