Bloodworks — FDA Facility Profile

FEI 3011537051

Bloodworks is an FDA-inspected facility (FEI 3011537051) located in Portland, OR, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 21, 2023: No Action Indicated (NAI)
Inspections on record
4 (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
1, latest Nov 4, 2020

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.

DateResultWhat FDA cited
Dec 21, 2023No Action Indicated (NAI)No citations listed
Mar 11, 2020No Action Indicated (NAI)No citations listed
Dec 18, 2017No Action Indicated (NAI)No citations listed
Aug 24, 2016No Action Indicated (NAI)No citations listed

Recalls

Newest first. 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.

DateClassRecallProduct and reason
Nov 4, 2020Class IIIB-0152-2021Red Blood Cells, Leukocytes Reduced
Leukoreduced, Red Blood Cells were distributed without a final visual check.

Facility details

Company
Bloodworks
Location
Portland, OR (US)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.