1195728
Embolx, Inc. — FEI 3011660785
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |