HealthPartners Institute IRB FDA Record
- Latest inspection VAI · Mar 14, 2022
- No warning letters matched by name
HealthPartners Institute IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "HealthPartners Institute IRB" is on file.
- Latest inspection
- Mar 14, 2022 · VAI
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 | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
HealthPartners Institute IRB: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2022 | Bloomington, MN | Devices | Voluntary Action Indicated (VAI) | 2127271 |
| May 28, 2019 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2127271 |
| May 13, 2013 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2127271 |
| Oct 29, 2009 | Bloomington, MN | Devices | Voluntary Action Indicated (VAI) | 2127271 |
- 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 2127271 | Bloomington, MN | 4 | Mar 14, 2022 |
HealthPartners Institute IRB and the FDA: common questions
Has HealthPartners Institute IRB received an FDA warning letter?
No FDA warning letter addressed to the name "HealthPartners Institute IRB" 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 HealthPartners Institute IRB received an FDA Form 483?
FDA has not published a Form 483 for "HealthPartners Institute IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect HealthPartners Institute IRB?
The most recent FDA inspection on file ended Mar 14, 2022 at Bloomington, MN and was classified VAI. FDA has 4 inspections of HealthPartners Institute IRB on file, 1 of them classified OAI (official action indicated).
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