1176147
Sonablate Corp. — FEI 3007126306
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |