FDA Inspection 1093677 — NeuroSync, Inc.
The FDA completed an inspection of NeuroSync, Inc. on June 20, 2019 in Holliston, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 20, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Holliston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |