1000696
Abbott Medical — FEI 2017865
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sylmar, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |