932465
Avreo Inc — FEI 3002716585
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |