1303422
Jatex, Inc. — FEI 3010049501
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nappanee, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |