FDA Inspection 1236405 — Virtex
The FDA completed an inspection of Virtex on April 19, 2024 in Anoka, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anoka, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |