FDA Inspection 1302476 — AR Fabricating
The FDA completed an inspection of AR Fabricating on February 11, 2026 in Georgetown, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: 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 |