FDA Inspection 1083557 — OrthoSource Inc
The FDA completed an inspection of OrthoSource Inc on March 21, 2019 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |