1022495
Agendia, Inc. — FEI 3007297853
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |