FDA Inspection 1308242 — Virtual Radiologic Corporation
The FDA completed an inspection of Virtual Radiologic Corporation on March 5, 2026 in Edina, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Edina, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23067 | ISO 13485:2016 Clause 6.1(a) | Resources for quality management system have not been determined or provided |
| 23070 | ISO 13485:2016 Clause 6.2 | Process(es) for personnel competence, training and awareness not documented |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |