Oregon Fertility Institute, LLC FDA Record
Oregon Fertility Institute, LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Oregon Fertility Institute, LLC" is on file.
- Latest inspection
- Apr 10, 2025 · 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 | 8 | 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
| 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 10, 2025 | Portland, OR | Biologics | No Action Indicated (NAI) | 3008307753 |
| Aug 18, 2021 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3008307753 |
| Oct 10, 2017 | Portland, OR | Biologics | No Action Indicated (NAI) | 3008307753 |
| Apr 14, 2015 | Portland, OR | Biologics | No Action Indicated (NAI) | 3008307753 |
| Jun 27, 2014 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3008307753 |
| May 22, 2013 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3008307753 |
| Jul 19, 2012 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3008307753 |
| Apr 27, 2011 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3008307753 |
- 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 3008307753 | Portland, OR | 8 | Apr 10, 2025 |
Oregon Fertility Institute, LLC and the FDA: common questions
Has Oregon Fertility Institute, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Oregon Fertility Institute, LLC" 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 Fertility Institute, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Oregon Fertility Institute, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Oregon Fertility Institute, LLC?
The most recent FDA inspection on file ended Apr 10, 2025 at Portland, OR and was classified NAI. FDA has 8 inspections of Oregon Fertility Institute, LLC on file.
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