Vitalant FDA Inspection Record
Vitalant is an FDA-inspected facility (FEI 2077574) located in Ventura, CA, US. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 30, 2025: No Action Indicated (NAI)
- Inspections on record
- 6 (1 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
- 28, latest Aug 18, 2022
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 30, 2025 | No Action Indicated (NAI) | No citations listed |
| Feb 24, 2022 | No Action Indicated (NAI) | No citations listed |
| Jul 12, 2018 | No Action Indicated (NAI) | No citations listed |
| Feb 19, 2016 | No Action Indicated (NAI) | No citations listed |
| Sep 15, 2014 | No Action Indicated (NAI) | No citations listed |
| Jun 27, 2010 | Voluntary Action Indicated (VAI) | Equipment calibration frequency (21 CFR 606.60(b)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Biological product deviation report (21 CFR 606.171) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 18, 2022 | Class II | B-0256-2023 | Apheresis Platelets, Leukocytes Reduced Plateletepheresis products, where associated blood sample collection tubes were mislabeled, were distributed. |
| May 17, 2019 | Class III | B-0734-2019 | Blood and Blood Products for Reprocessing Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. |
| Aug 12, 2016 | Class II | B-0113-2017 | Apheresis Platelets, Leukocytes Reduced, Irradiated and 1 more product Platelet products, which did not meet quality control specifications, were distributed. |
| Jul 27, 2016 | Class II | B-0780-16 | Apheresis Platelets, Leukocytes Reduced, Irradiated and 1 more product Apheresis products, in which quality control for WBC testing was not performed, were distributed. |
| Apr 22, 2016 | Class II | B-0670-16 | Red Blood Cells, Leukocytes Reduced Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. |
| Mar 4, 2016 | Class II | B-0474-16 | Apheresis Red Blood Cells, Leukocytes Reduced Apheresis products collected from donors taking Propecia and Accutane were distributed. |
| Jan 29, 2016 | Class II | B-0408-16 | Blood and Blood Products for Reprocessing Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. |
| Jan 28, 2016 | Class II | B-0468-16 | Red Blood Cells, Leukocytes Reduced Blood products, possibly collected from a donor who traveled to a malarial endemic area, were distributed. |
| Nov 12, 2015 | Class II | B-0233-16 | Apheresis Platelets, Leukocytes Reduced Blood product, in which quality control and distribution of product did not meet specifications, was distributed. |
| Sep 14, 2015 | Class III | B-0068-16 | Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated Apheresis blood products, incorrectly labeled as having an extended expiration date, were distributed. |
Facility details
- Company
- Vitalant
- Location
- Ventura, CA (US)
- Source
- inspections