Company
United StatesSt. Luke's Regional Breast Center, Duluth, MN – FDA Inspections
Inspection records and compliance data for St. Luke's Regional Breast Center in Duluth, MN. 7 FDA inspections on record, last inspected February 26, 2026.
Company Profile
This profile covers St. Luke's Regional Breast Center based in Duluth, MN, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 7
- Form 483s
- 0
- Warning letters
- 0
First inspected November 3, 2016. Last inspected February 26, 2026.
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 26, 2026 | Not classified | Medical Devices & Rad Health | 1306404 |
| March 10, 2025 | Not classified | Medical Devices & Rad Health | 1267289 |
| April 11, 2024 | Not classified | Medical Devices & Rad Health | 1251620 |
| May 17, 2023 | Not classified | Medical Devices & Rad Health | 1206959 |
| December 21, 2018 | Not classified | Medical Devices & Rad Health | 1075759 |
| January 9, 2018 | Not classified | Medical Devices & Rad Health | 1038167 |
| November 3, 2016 | Not classified | Medical Devices & Rad Health | 990732 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
St. Luke's Regional Breast Center
FEI Number
1000520415
Address
Radiology Department, 915 E 1st St, Duluth, MN 55805-2107, United States
Country
United States
ID: 1b82ca1a-372f-45c7-ae1f-451cccc88667