1028588
Aurora Spine Inc — FEI 3010326971
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |