1190863
Neuronetrix Solutions, LLC — FEI 3011184129
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 7, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4208 | 21 CFR 806.20(a) | Records not kept |