FDA Inspection
Gambro UF Solutions LLCGambro UF Solutions LLC – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Gambro UF Solutions LLC, with an inspection on September 18, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
- Company
- Gambro UF Solutions LLC
- Inspection Date
- September 18, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 3c7c5948-ac5c-4136-9e79-b5f08d15c76a
Inspection Facts
- Inspection number
- 1337898
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
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Other FDA inspections of Gambro UF Solutions LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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