FDA Inspection 1323318 — BRAINSPEC, INC
The FDA completed an inspection of BRAINSPEC, INC on June 24, 2026 in Framingham, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Framingham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |