769486
Natus Medical Incorporated — FEI 3018859
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |