1181180
Hoggan Scientific LLC — FEI 3009787507
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 30, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |