725918
Cleveland Medical Devices Inc — FEI 3000206198
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 1, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |