FDA inspection
Urotronic, Inc.: FDA inspection ending Jul 16, 2021
FDA inspection 1148295 · No Action Indicated (NAI) · Plymouth, Minnesota
Key facts
| Inspection ID | 1148295 |
|---|---|
| Firm | Urotronic, Inc. |
| FEI number | 3015228875 |
| Address | 2495 Xenium Ln N |
| City | Plymouth |
| State | Minnesota |
| ZIP | 55441 |
| Fiscal year | 2021 |
| Inspection end date | Jul 16, 2021 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: 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Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med 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Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data