Warning letter
NeuroSync, Inc.: warning letter of May 9, 2025
FDA warning letter 705489 · Center for Devices and Radiological Health
Key facts
| Reference number | 705489 |
|---|---|
| Company | NeuroSync, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 9, 2025 |
| Posted date | May 20, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.20(a), 820, 801, 801.3, 801.40(a)(1), 801.40(a)(2), 806, 806.10, 830 |
| Inspection city | Holliston |
| Inspection ZIP | 01746 |
| Inspection start date | Jan 6, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: