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Bloodworks

FDA Regulatory Profile

Bloodworks has 0 FDA recalls, 112 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Bloodworks".

Latest inspection
Jul 15, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections112Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Bloodworks's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Bloodworks: FDA inspections per year 2017: 9 inspections920172018: 7 inspections720182019: 5 inspections520192020: 2 inspections220202021: 3 inspections320212022: 6 inspections620222023: 5 inspections520232024: 1 inspections120242025: 1 inspections120252026: 8 inspections82026
YearInspectionsOAIWarning lettersRecall recordsClass I
202680000
202510000
202410000
202350000
202260000
202130000
202020000
201950000
201870000
201790000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

112 inspections from Dec 8, 2008 to Jul 15, 2026. Showing the 20 most recent. View all 112 inspections

DateSiteProductClassificationFEI
Jul 15, 2026Lynnwood, WABiologicsNo Action Indicated (NAI)3003140569
Jun 30, 2026Bellingham, WABiologicsNo Action Indicated (NAI)3000206550
Jun 18, 2026Federal Way, WABiologicsNo Action Indicated (NAI)3006417870
Apr 15, 2026Seattle, WABiologicsNo Action Indicated (NAI)3023087
Apr 8, 2026Renton, WABiologicsNo Action Indicated (NAI)3019844
Mar 20, 2026Vancouver, WABiologicsNo Action Indicated (NAI)3005996806
Jan 29, 2026Olympia, WABiologicsNo Action Indicated (NAI)1000524514
Jan 21, 2026Everett, WABiologicsNo Action Indicated (NAI)3070006
Dec 11, 2025Seattle, WABiologicsVoluntary Action Indicated (VAI)3071347
May 3, 2024Seattle, WABiologicsNo Action Indicated (NAI)3071347
Dec 21, 2023Portland, ORBiologicsNo Action Indicated (NAI)3011537051
Dec 21, 2023Kirkland, WABiologicsNo Action Indicated (NAI)3012302397
Nov 29, 2023Renton, WABiologicsNo Action Indicated (NAI)3010267773
Nov 8, 2023Bellevue, WABiologicsNo Action Indicated (NAI)3020842
Oct 26, 2023Renton, WABiologicsNo Action Indicated (NAI)3001617760
Nov 9, 2022Renton, WABiologicsNo Action Indicated (NAI)3019844
Jun 1, 2022Olympia, WABiologicsNo Action Indicated (NAI)1000524514
Mar 15, 2022Seattle, WABiologicsNo Action Indicated (NAI)3023087
Mar 9, 2022Silverdale, WABiologicsNo Action Indicated (NAI)3001878572
Mar 3, 2022Everett, WABiologicsNo Action Indicated (NAI)3070006
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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Bloodworks: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 16, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

16 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003140569Lynnwood, WA8Jul 15, 2026
FEI 3000206550Bellingham, WA7Jun 30, 2026
FEI 3006417870Federal Way, WA7Jun 18, 2026
FEI 3023087Seattle, WA7Apr 15, 2026
FEI 3019844Renton, WA9Apr 8, 2026
FEI 3005996806Vancouver, WA8Mar 20, 2026
FEI 1000524514Olympia, WA7Jan 29, 2026
FEI 3070006Everett, WA7Jan 21, 2026
FEI 3071347Seattle, WA16Dec 11, 2025
FEI 3011537051Portland, OR4Dec 21, 2023
FEI 3012302397Kirkland, WA3Dec 21, 2023
FEI 3010267773Renton, WA4Nov 29, 2023
FEI 3020842Bellevue, WA7Nov 8, 2023
FEI 3001617760Renton, WA8Oct 26, 2023
FEI 3001878572Silverdale, WA6Mar 9, 2022
FEI 3009058002Seattle, WA4Jan 5, 2016

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FDA data resources

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