Bloodworks Northwest FDA Record
Bloodworks Northwest has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bloodworks Northwest" is on file.
- Latest inspection
- Apr 23, 2024 · 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 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 |
|---|---|---|---|---|
| Apr 23, 2024 | Eugene, OR | Biologics | No Action Indicated (NAI) | 3071915 |
| Apr 3, 2019 | Eugene, OR | Biologics | No Action Indicated (NAI) | 3071915 |
| Apr 2, 2015 | Eugene, OR | Biologics | No Action Indicated (NAI) | 3071915 |
| Apr 23, 2013 | Eugene, OR | Biologics | Voluntary Action Indicated (VAI) | 3071915 |
| Aug 30, 2012 | Eugene, OR | Biologics | Voluntary Action Indicated (VAI) | 3071915 |
| Jul 18, 2011 | Eugene, OR | Biologics | Voluntary Action Indicated (VAI) | 3071915 |
| Jun 11, 2009 | Eugene, OR | Biologics | No Action Indicated (NAI) | 3071915 |
- 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 3071915 | Eugene, OR | 7 | Apr 23, 2024 |
Bloodworks Northwest and the FDA: common questions
Has Bloodworks Northwest received an FDA warning letter?
No FDA warning letter addressed to the name "Bloodworks Northwest" 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 Bloodworks Northwest received an FDA Form 483?
FDA has not published a Form 483 for "Bloodworks Northwest" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bloodworks Northwest?
The most recent FDA inspection on file ended Apr 23, 2024 at Eugene, OR and was classified NAI. FDA has 7 inspections of Bloodworks Northwest on file.
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