662534
Cranial Solutions — FEI 3003524425
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 14, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pompton Lakes, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |