Bloodworks — FDA Facility Profile
Bloodworks is an FDA-inspected facility (FEI 3010267773) located in Renton, WA, US. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 29, 2023: 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
- Recalls as the recalling firm
- 2, latest Dec 29, 2023
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 29, 2023 | No Action Indicated (NAI) | No citations listed |
| Oct 26, 2018 | No Action Indicated (NAI) | No citations listed |
| Oct 19, 2016 | No Action Indicated (NAI) | No citations listed |
| Oct 15, 2014 | Voluntary Action Indicated (VAI) | Person performing, test results, interpretation (21 CFR 606.160(a)(1)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 29, 2023 | Class III | B-0140-2024 | Plasma Thawed and 2 more products Blood products that lacked assurance of proper storage temperatures, were distributed. |
| Apr 21, 2021 | Class II | B-0403-2021 | Red Blood Cells, Leukocytes Reduced Misbranded Red Blood Cell products were distributed. |
Facility details
- Company
- Bloodworks
- Location
- Renton, WA (US)
- Source
- inspections