FDA Inspection 1332018 — Neurotron, Inc.
The FDA completed an inspection of Neurotron, Inc. on Aug 21, 2026 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 23162 | ISO 13485:2016 Clause 7.5.4 | Servicing procedures and reference materials and measurements not documented |
| 23181 | ISO 13485:2016 Clause 7.5.8 | Product status identification was not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |