Bloodworks — FDA Facility Profile
Bloodworks is an FDA-inspected facility (FEI 3019844) located in Renton, WA, US. RegDataLab tracks 9 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 8, 2026: No Action Indicated (NAI)
- Inspections on record
- 9 (2 VAI, 7 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 8, 2026 | No Action Indicated (NAI) | No citations listed |
| Nov 9, 2022 | No Action Indicated (NAI) | No citations listed |
| Jul 18, 2019 | No Action Indicated (NAI) | No citations listed |
| Aug 26, 2016 | No Action Indicated (NAI) | No citations listed |
| Sep 5, 2014 | No Action Indicated (NAI) | No citations listed |
| Jan 30, 2013 | No Action Indicated (NAI) | No citations listed |
| Mar 9, 2012 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Oct 26, 2010 | Voluntary Action Indicated (VAI) | Required records (21 CFR 606.160(b)) Storage temps./agitation (21 CFR 640.25(a)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Dec 8, 2008 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Bloodworks
- Location
- Renton, WA (US)
- Source
- inspections