1302724
SVTRONICS INC — FEI 3005698910
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 23154 | ISO 13485:2016 Clause 7.4.3 | Records of purchased product verification not maintained |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |
| 23209 | ISO 13485:2016 Clause 8.1 | Methods for monitoring, measurement, analysis, and improvement not determined |