FDA Inspection 854917 — Rocky Mountain Research, Inc.
The FDA completed an inspection of Rocky Mountain Research, Inc. on November 8, 2013 in Park City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: 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 |