FDA Inspection 947135 — OrthoSource Inc
The FDA completed an inspection of OrthoSource Inc on November 4, 2015 in Van Nuys, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |