FDA Inspection 705237 — Interventional Spine Inc
The FDA completed an inspection of Interventional Spine Inc on February 4, 2011 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |