FDA Inspection
VitalantVitalant – FDA Inspection, Aug 15, 2012
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on August 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- August 15, 2012
- Product Type
- Biologics
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ID · 4e0d2829-72dc-49b1-8fcf-12d2ff488c7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795373
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitalant
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 29, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 13, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1258010 - 2024-11-22
- FDA Inspection 1106275 - 2019-09-05
- FDA Inspection 1000905 - 2017-02-10
- FDA Inspection 937619 - 2015-07-29
- FDA Inspection 848182 - 2013-09-13
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