1017180
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waldo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |