Company
United StatesGambro UF Solutions LLC, Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Gambro UF Solutions LLC in Minneapolis, Minnesota. 3 FDA inspections on record, 1 Form 483, last inspected September 18, 2026.
Company Profile
This profile covers Gambro UF Solutions LLC based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 12, 2011. Last inspected September 18, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Design and development validation not complete prior to release of product1 inspection
- Preventive action procedures not documented1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1337898 |
| November 3, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 952985 |
| May 12, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 723785 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gambro UF Solutions LLC
FEI Number
3003504604
Address
1405 Xenium Ln N Ste 150, Minneapolis, Minnesota 55441, United States
Country
United States
ID: 0669d509-c3ab-4ff5-9ef8-8ed80a8fdc30