Legacy Emanuel Medical Center FDA Record
- Latest inspection NAI · Dec 28, 2023
- No warning letters matched by name
Legacy Emanuel Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Legacy Emanuel Medical Center" is on file.
- Latest inspection
- Dec 28, 2023 · 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 | 7 | 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
Legacy Emanuel Medical Center: 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 28, 2023 | Portland, OR | Biologics | No Action Indicated (NAI) | 3075096 |
| Mar 10, 2020 | Portland, OR | Biologics | No Action Indicated (NAI) | 3075096 |
| May 4, 2018 | Portland, OR | Biologics | No Action Indicated (NAI) | 3075096 |
| Oct 9, 2015 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3075096 |
| Nov 15, 2013 | Portland, OR | Biologics | No Action Indicated (NAI) | 3075096 |
| Dec 6, 2011 | Portland, OR | Biologics | No Action Indicated (NAI) | 3075096 |
| Oct 22, 2009 | Portland, OR | Biologics | Voluntary Action Indicated (VAI) | 3075096 |
- 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 3075096 | Portland, OR | 7 | Dec 28, 2023 |
Legacy Emanuel Medical Center and the FDA: common questions
Has Legacy Emanuel Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Legacy Emanuel Medical Center" 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 Legacy Emanuel Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Legacy Emanuel Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Legacy Emanuel Medical Center?
The most recent FDA inspection on file ended Dec 28, 2023 at Portland, OR and was classified NAI. FDA has 7 inspections of Legacy Emanuel Medical Center on file.
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