1246096
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 1, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hopkins, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |