FDA Inspection 607359 — Insource Orthopedics, LLC
The FDA completed an inspection of Insource Orthopedics, LLC on August 25, 2009 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 2403 | 21 CFR 820.25(a) | Sufficient personnel |
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3144 | 21 CFR 820.160(a) | Control/distribution procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |