592352
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Valley City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |