854917
Rocky Mountain Research, Inc. — FEI 1000065453
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Park City, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |