FDA Inspection 774581 — Dynasthetics LLC
The FDA completed an inspection of Dynasthetics LLC on Mar 29, 2012 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 29, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3668 | 21 CFR 820.20(c) | Management review dates |