Company
United StatesUrologix LLC, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Urologix LLC in Plymouth, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected July 01, 2026.
Company Profile
This profile covers Urologix LLC based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected July 23, 2010. Last inspected July 1, 2026.
Most cited issue areas
- Corrective actions were unduly delayed1 inspection
- Internal audits not conducted to ensure QMS meets requirements and is effective1 inspection
- Maintenance records not maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 1, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1325556 |
| March 18, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1165281 |
| November 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 996470 |
| July 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 840433 |
| July 23, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 673047 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Urologix LLC
FEI Number
3000718675
Address
13355 10th Ave N Ste 110, Plymouth, Minnesota 55441, United States
Country
United States
ID: f287b524-dee8-43d3-a38e-d795b8c5bd6b