1148958
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |