The Blood Center — FDA Facility Profile
The Blood Center is an FDA-inspected facility (FEI 2374536) located in Hammond, LA, US. RegDataLab tracks 9 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 16, 2024: No Action Indicated (NAI)
- Inspections on record
- 9 (4 VAI, 5 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
- 84, latest Jul 10, 2025
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 16, 2024 | No Action Indicated (NAI) | No citations listed |
| Jun 17, 2022 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Biological product deviation report (21 CFR 606.171) Thorough investigations (21 CFR 606.100(c)) |
| Apr 17, 2019 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Jun 29, 2017 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Biological product deviation report (21 CFR 606.171) |
| Jul 16, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 11, 2014 | No Action Indicated (NAI) | No citations listed |
| May 18, 2012 | No Action Indicated (NAI) | No citations listed |
| Aug 25, 2011 | No Action Indicated (NAI) | No citations listed |
| Sep 3, 2010 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 10, 2025 | Class II | B-0202-2026 | Red Blood Cells, Leukocytes Reduced Red Blood Cells, Leukocytes Reduced, incorrectly labeled as irradiated, were distributed. |
| Apr 15, 2025 | Class II | B-0131-2026 | Red Blood Cells, Leukocytes Reduced Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count… |
| Apr 11, 2025 | Class II | B-0146-2026 | Platelets, Pathogen Reduced Platelets, Pathogen Reduced, for which platelet yield did not meet specifications, were distributed. |
| Oct 24, 2022 | Class II | B-0331-2023 | Red Blood Cells and 1 more product Blood products, collected from a donor previously deferred for testing reactive for syphilis, were distributed. |
| Oct 4, 2022 | Class II | B-0250-2023 | Platelets, Pathogen Reduced and 1 more product Blood products, collected from donors previously deferred for testing reactive for syphilis and who were not properly tested for re-entry… |
| Aug 12, 2022 | Class II | B-0203-2023 | Platelets, Pathogen Reduced and 5 more products Blood Products, collected from a donor who initially tested reactive for syphilis but did not have confirmatory testing performed according… |
| Nov 16, 2021 | Class II | B-0178-2022 | Platelets, Pathogen Reduced Blood product, collected from a donor who previously tested positive for Hepatitis B core antigen (anti-HBc) on two separate occasions, was… |
| Nov 5, 2019 | Class III | B-0336-2020 | Apheresis Red Blood Cells, Leukocytes Reduced Misbranded Apheresis Red Blood Cells, Leukoreduced, were distributed. |
| Sep 27, 2019 | Class II | B-0092-2020 | Red Blood Cells and 1 more product Red Blood Cell products, for which Chagas Disease testing was not performed, were distributed. |
| Apr 8, 2019 | Class III | B-0687-2019 | Red Blood Cells, Leukocytes Reduced, Irradiated Blood product, which was irradiated labeled with an incorrect expiration date, was distributed. |
Facility details
- Company
- The Blood Center
- Location
- Hammond, LA (US)
- Source
- inspections