FDA Inspection 1181180 — Hoggan Scientific LLC
The FDA completed an inspection of Hoggan Scientific LLC on Sep 30, 2022 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: 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} |