FDA Inspection 1331706 — Hoggan Scientific LLC
The FDA completed an inspection of Hoggan Scientific LLC on Aug 19, 2026 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |
| 23148 | ISO 13485:2016 Clause 7.4.2 | Purchasing information lacks written agreement regarding notification of changes |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |