FDA Inspection 1158911 — Mivi Neuroscience Inc
The FDA completed an inspection of Mivi Neuroscience Inc on December 14, 2021 in Eden Prairie, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |