1302476
AR Fabricating — FEI 3010143171
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Georgetown, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |