Bloodworks — FDA Facility Profile
Bloodworks is an FDA-inspected facility (FEI 3001617760) located in Renton, WA, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 26, 2023: No Action Indicated (NAI)
- Inspections on record
- 8 (2 VAI, 6 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
- 24, latest Mar 14, 2025
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 26, 2023 | No Action Indicated (NAI) | No citations listed |
| Mar 22, 2019 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Feb 17, 2017 | No Action Indicated (NAI) | No citations listed |
| Feb 4, 2015 | No Action Indicated (NAI) | No citations listed |
| Jul 3, 2014 | No Action Indicated (NAI) | General requirements - storage (21 CFR 640.11(a)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Jul 6, 2012 | Voluntary Action Indicated (VAI) | Biological product deviation report (21 CFR 606.171) Thorough investigations (21 CFR 606.100(c)) |
| Sep 22, 2010 | No Action Indicated (NAI) | No citations listed |
| May 5, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 14, 2025 | Class III | B-0070-2026 | Platelets Extended Dating Platelets, Extended Dating, for which a visual inspection was not performed or documented, were distributed. |
| Sep 23, 2024 | Class II | B-0209-2025 | Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced Leukoreduced Apheresis Platelets products, possibly exposed to unacceptable shipping temperatures due to extended transit time, were… |
| Aug 29, 2024 | Class II | B-0035-2025 | Platelets Extended Dating and 1 more product Blood Products, collected by automated equipment that was not properly maintained, was distributed. |
| Aug 28, 2024 | Class III | B-0061-2025 | Red Blood Cells, Leukocytes Reduced Leukoreduced Red Blood Cells product, for which a visual inspection was not performed or documented, was distributed. |
| Jul 22, 2024 | Class II | B-0228-2025 | Red Blood Cells, Leukocytes Reduced, Irradiated Red Blood Cells, Leukocytes Reduced, Irradiated, which were out of monitored storage for an extended period of time, were distributed. |
| Dec 15, 2023 | Class II | B-0211-2024 | Platelets Extended Dating Platelets Extended Dating, which were not tested for pH, were distributed. |
| Dec 14, 2023 | Class II | B-0177-2024 | Platelets Extended Dating Platelets Extended Dating, which were not tested for pH, were distributed. |
| Sep 3, 2023 | Class II | B-0020-2024 | Platelets Extended Dating Platelets Extended Dating, in which the platelet yield did not meet specifications, were distributed. |
| Jun 7, 2023 | Class II | B-0537-2023 | Platelets Extended Dating Platelets Extended Dating, which were not tested for pH, were distributed. |
| Jun 5, 2023 | Class III | B-0538-2023 | Red Blood Cells, Leukocytes Reduced Leukoreduced Red Blood Cells were distributed without a final visual check. |
Facility details
- Company
- Bloodworks
- Location
- Renton, WA (US)
- Source
- inspections