Oregon Health & Science University FDA Record
- Latest inspection NAI · Jan 29, 2026
- Last warning letter 2010
Oregon Health & Science University has 0 FDA recalls, 24 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Oregon Health & Science University, the most recent on Jun 23, 2010.
- Latest inspection
- Jan 29, 2026 · NAI
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 | 24 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Oregon Health & Science University: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 3 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Oregon Health & Science University FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 23, 2010 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 29, 2026 | Portland, OR | Biologics | No Action Indicated (NAI) | 3072905 |
| Jun 26, 2025 | Portland, OR | Biologics | No Action Indicated (NAI) | 3004147742 |
| Aug 10, 2022 | Portland, OR | Biologics | No Action Indicated (NAI) | 3017876934 |
| Aug 9, 2022 | Portland, OR | Biologics | No Action Indicated (NAI) | 3072905 |
| Mar 8, 2022 | Portland, OR | Biologics | No Action Indicated (NAI) | 3004147742 |
| Sep 17, 2019 | Portland, OR | Biologics | No Action Indicated (NAI) | 3004147742 |
| Jul 17, 2018 | Portland, OR | Biologics | No Action Indicated (NAI) | 3072905 |
| Sep 14, 2016 | Portland, OR | Biologics | No Action Indicated (NAI) | 3004147742 |
| Jan 28, 2016 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3072905 |
| Jun 25, 2015 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3004147742 |
| Jun 25, 2014 | Portland, OR | Biologics | No Action Indicated (NAI) | 3003568554 |
| Jan 10, 2014 | Portland, OR | Biologics | No Action Indicated (NAI) | 3072905 |
| May 20, 2013 | Portland, OR | Biologics | No Action Indicated (NAI) | 3004147742 |
| Jul 25, 2012 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3004147742 |
| Jan 12, 2012 | Portland, OR | Biologics | No Action Indicated (NAI) | 3072905 |
| May 27, 2011 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3004147742 |
| Nov 15, 2010 | Portland, OR | Biologics | No Action Indicated (NAI) | 3003568554 |
| Oct 25, 2010 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3072905 |
| Jun 9, 2010 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3004147742 |
| May 12, 2010 | Portland, OR | Biologics | No Action Indicated (NAI) | 3003568554 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Oregon Health & Science University: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3072905 | Portland, OR | 10 | Jan 29, 2026 |
| FEI 3004147742 | Portland, OR | 9 | Jun 26, 2025 |
| FEI 3017876934 | Portland, OR | 1 | Aug 10, 2022 |
| FEI 3003568554 | Portland, OR | 4 | Jun 25, 2014 |
Oregon Health & Science University and the FDA: common questions
Has Oregon Health & Science University received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Oregon Health & Science University. The most recent is dated Jun 23, 2010.
Has Oregon Health & Science University received an FDA Form 483?
FDA has not published a Form 483 for "Oregon Health & Science University" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Oregon Health & Science University?
The most recent FDA inspection on file ended Jan 29, 2026 at Portland, OR and was classified NAI. FDA has 24 inspections of Oregon Health & Science University on file, 2 of them classified OAI (official action indicated).
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