1058966
Intelligent Implant Systems — FEI 3011121367
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |