1095771
Medfaxx, Inc. — FEI 3001451345
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wake Forest, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |