The Community Blood Center, Inc. FDA Inspection Record
The Community Blood Center, Inc. is an FDA-inspected facility (FEI 2171896) located in Appleton, WI, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 20, 2024: No Action Indicated (NAI)
- Inspections on record
- 8 (3 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
- 27, latest Jul 3, 2024
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 20, 2024 | No Action Indicated (NAI) | No citations listed |
| Mar 4, 2020 | Voluntary Action Indicated (VAI) | Thorough investigations (21 CFR 606.100(c)) |
| Mar 10, 2017 | No Action Indicated (NAI) | No citations listed |
| Aug 27, 2015 | No Action Indicated (NAI) | No citations listed |
| Jul 18, 2013 | No Action Indicated (NAI) | No citations listed |
| Jun 1, 2012 | No Action Indicated (NAI) | No citations listed |
| Aug 16, 2011 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Oct 14, 2009 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) When to report (21 CFR 600.14(c)) Results of testing (21 CFR 630.40(b)(3)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 3, 2024 | Class II | B-0470-2024 | Apheresis Platelets, Leukocytes Reduced, Irradiated Leukoreduced Apheresis Platelets, Irradiated, that were not properly Irradiated, were distributed. |
| Mar 6, 2024 | Class III | B-0177-2025 | Apheresis Fresh Frozen Plasma and 2 more products Plasma products, which were missing information due to label printer misalignment, were distributed. |
| Oct 19, 2023 | Class II | B-0089-2024 | Pathogen Reduced Cryoprecipitated Fibrinogen Complex Pathogen Reduced Cryoprecipitated Fibrinogen Complex, which was incorrectly processed, was distributed. |
| Aug 5, 2023 | Class III | B-0680-2023 | Red Blood Cells, Leukocytes Reduced, Irradiated Leukoreduced Red Blood Cells, Irradiated, which had an incorrect expiration date, were distributed. |
| May 3, 2023 | Class III | B-0523-2023 | Apheresis Red Blood Cells, Leukocytes Reduced Apheresis Red Blood Cell product, stored at unacceptable or undocumented temperature, was distributed. |
| Jul 20, 2022 | Class II | B-0131-2023 | Red Blood Cells, Leukocytes Reduced Red Blood Cell products, for which arm prep may have been performed inappropriately, were distributed. |
| Jun 2, 2022 | Class II | B-0167-2023 | Fresh Frozen Plasma and 2 more products Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
| May 27, 2022 | Class III | B-0058-2023 | Red Blood Cells, Leukocytes Reduced Leukoreduced Red Blood Cells, which had an incorrect expiration date on the label, were distributed. |
| Jul 15, 2021 | Class II | B-0565-2021 | Red Blood Cells, Leukocytes Reduced, Irradiated Leukoreduced Irradiated Red Blood Cells, which were not labeled as Irradiated, were distributed. |
| Apr 29, 2021 | Class III | B-0481-2021 | Apheresis Red Blood Cells, Leukocytes Reduced Blood product, exposed to unacceptable temperatures during storage, was distributed. |
Facility details
- Company
- The Community Blood Center, Inc.
- Location
- Appleton, WI (US)
- Source
- inspections