1177105
BODY VISION MEDICAL — FEI 3014491269
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Herzliya (Israel)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |