FDA Inspection 561896 — Rocky Mountain Orthodontics
The FDA completed an inspection of Rocky Mountain Orthodontics on Feb 5, 2009 in Franklin, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Franklin, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3325 | 21 CFR 820.180 | Storage |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |