Oregon Health & Science University IRB FDA Record
- Latest inspection NAI · Oct 14, 2025
- No warning letters matched by name
Oregon Health & Science University IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Oregon Health & Science University IRB" is on file.
- Latest inspection
- Oct 14, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 4 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Oregon Health & Science University IRB: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Reviewing Oregon Health & Science University IRB as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Oregon Health & Science University IRB yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 14, 2025 | Portland, OR | Drugs | No Action Indicated (NAI) | 3019494 |
| Jun 30, 2021 | Portland, OR | Devices | No Action Indicated (NAI) | 3019494 |
| Jun 13, 2014 | Portland, OR | Biologics | No Action Indicated (NAI) | 3019494 |
| May 26, 2010 | Portland, OR | Biologics | No Action Indicated (NAI) | 3019494 |
- 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 3019494 | Portland, OR | 4 | Oct 14, 2025 |
Oregon Health & Science University IRB and the FDA: common questions
Has Oregon Health & Science University IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Oregon Health & Science University 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 Oregon Health & Science University IRB received an FDA Form 483?
FDA has not published a Form 483 for "Oregon Health & Science University IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Oregon Health & Science University IRB?
The most recent FDA inspection on file ended Oct 14, 2025 at Portland, OR and was classified NAI. FDA has 4 inspections of Oregon Health & Science University IRB on file.
Need more than this page shows? Ask about Oregon Health & Science University IRB in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.