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Bloodworks — FDA Facility Profile

FEI 3009058002

Bloodworks is an FDA-inspected facility (FEI 3009058002) located in Seattle, WA, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 5, 2016: No Action Indicated (NAI)
Inspections on record
4 (1 VAI, 3 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

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
Jan 5, 2016No Action Indicated (NAI)No citations listed
Feb 19, 2014No Action Indicated (NAI)No citations listed
Nov 14, 2012No Action Indicated (NAI)No citations listed
Dec 6, 2011Voluntary Action Indicated (VAI)Person performing, test results, interpretation (21 CFR 606.160(a)(1))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))

Facility details

Company
Bloodworks
Location
Seattle, WA (US)
Source
inspections

FDA data resources

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