FDA Inspection 1302724 — SVTRONICS INC
The FDA completed an inspection of SVTRONICS INC on February 13, 2026 in Plano, 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 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 |