1114907
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 9, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |