1148287
CAIRE DIAGNOSTICS INC — FEI 3013216353
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pleasanton, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |