1107891
Unetixs Vascular, Inc. — FEI 1222117
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 29, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |