561409
Newport Medical Instruments Inc — FEI 2023050
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 29, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3837 | 21 CFR 820.25(b) | Training records |