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Bloodworks Northwest FDA Inspection Record

FEI 3071915 · Inspections, Form 483s, warning letters and import refusals

Bloodworks Northwest is an FDA-inspected facility (FEI 3071915) located in Eugene, OR, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Apr 23, 2024: No Action Indicated (NAI)
Inspections on record: 7 (3 VAI, 4 NAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm: 26, latest Oct 4, 2021

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Apr 23, 2024	No Action Indicated (NAI)	No citations listed
Apr 3, 2019	No Action Indicated (NAI)	No citations listed
Apr 2, 2015	No Action Indicated (NAI)	No citations listed
Apr 23, 2013	Voluntary Action Indicated (VAI)	Legibility and indelibility (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Notification (21 CFR 630.40(a))
Aug 30, 2012	Voluntary Action Indicated (VAI)	Person performing, test results, interpretation (21 CFR 606.160(a)(1)) Following manufacturer's instructions (21 CFR 606.65(e)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jul 18, 2011	Voluntary Action Indicated (VAI)	Person performing, test results, interpretation (21 CFR 606.160(a)(1)) Written methods for investigating adverse reactions (21 CFR 606.100(b)(9))
Jun 11, 2009	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 26 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Oct 4, 2021	Class III	B-0072-2022	Red Blood Cells, Leukocytes Reduced Red Blood Cell products, for which a visual inspection was not performed or documented, were distributed.
Aug 17, 2021	Class III	B-0001-2022	Red Blood Cells, Leukocytes Reduced Leukoreduced Red Blood Cells were distributed without a final visual check.
Oct 6, 2020	Class III	B-0097-2021	Apheresis Red Blood Cells, Leukocytes Reduced Leukoreduced, Apheresis Red Blood Cells were distributed without a final visual check.
Nov 19, 2015	Class II	B-0204-16	Red Blood Cells, Leukocytes Reduced Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Jul 15, 2015	Class III	B-0865-15	Red Blood Cells Leukocytes Reduced Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Jun 8, 2015	Class II	B-0853-15	Red Blood Cells Leukocytes Reduced Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Jun 2, 2015	Class II	B-0805-15	Cryoprecipitated AHF, Pooled Blood product, which was labeled with an incorrect expiration date, was distributed.
May 14, 2015	Class II	B-0755-15	Red Blood Cells Leukocytes Reduced Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Apr 23, 2015	Class II	B-0730-15	Blood and Blood Products for Reprocessing Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Sep 3, 2014	Class II	B-0128-15	Red Blood Cells Leukocytes Reduced Blood product, collected from an unsuitable donor, was distributed.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: Bloodworks Northwest
Location: Eugene, OR (US)
Source: inspections