FDA Inspection 1325556 — Urologix LLC
The FDA completed an inspection of Urologix LLC on Jul 1, 2026 in Plymouth, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plymouth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23022 | ISO 13485:2016 Clause 4.1.4 | QMS processes not adequately managed |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23078 | ISO 13485:2016 Clause 6.3 | Maintenance records not maintained |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 23256 | ISO 13485:2016 Clause 8.5.2 | Corrective actions were unduly delayed |