Hennepin County Med Ctr (Minneapolis) IRB #1 FDA Record
Hennepin County Med Ctr (Minneapolis) IRB #1 has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hennepin County Med Ctr (Minneapolis) IRB #1" is on file.
- Latest inspection
- Aug 23, 2018 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 23, 2018 | Minneapolis, MN | Drugs | Official Action Indicated (OAI) | 2127118 |
| Jun 19, 2014 | Minneapolis, MN | Drugs | Voluntary Action Indicated (VAI) | 2127118 |
| Apr 26, 2013 | Minneapolis, MN | Devices | No Action Indicated (NAI) | 2127118 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2127118 | Minneapolis, MN | 3 | Aug 23, 2018 |
Hennepin County Med Ctr (Minneapolis) IRB #1 and the FDA: common questions
Has Hennepin County Med Ctr (Minneapolis) IRB #1 received an FDA warning letter?
No FDA warning letter addressed to the name "Hennepin County Med Ctr (Minneapolis) IRB #1" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Hennepin County Med Ctr (Minneapolis) IRB #1 received an FDA Form 483?
FDA has not published a Form 483 for "Hennepin County Med Ctr (Minneapolis) IRB #1" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hennepin County Med Ctr (Minneapolis) IRB #1?
The most recent FDA inspection on file ended Aug 23, 2018 at Minneapolis, MN and was classified OAI. FDA has 3 inspections of Hennepin County Med Ctr (Minneapolis) IRB #1 on file, 1 of them classified OAI (official action indicated).
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