FDA Inspection
VitalantVitalant – FDA Inspection, May 8, 2017
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on May 8, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a36ac619-b859-4c68-b712-fc3d6afeb9a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011386
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 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
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2025 | Not classified | Seattle District Office | |
| September 24, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 30, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1277492 - 2025-07-18
- FDA Inspection 1154344 - 2021-09-24
- FDA Inspection 1106094 - 2019-09-20
- FDA Inspection 924066 - 2015-04-30
- FDA Inspection 837856 - 2013-06-26
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