FDA Inspection 1309246 — Neurotrack Technologies
The FDA completed an inspection of Neurotrack Technologies on March 25, 2026 in Redwood City, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Redwood City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23122 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not conducted on representative product |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23259 | ISO 13485:2016 Clause 8.5.2 | Corrective action records not maintained |