FDA Inspection
VitalantVitalant – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on February 10, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Mark W. Babbitt (Issuing Officer)
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ID · 16457b79-8da2-405e-8b06-7a324482a026
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000905
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| 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 |
| August 15, 2012 | 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 937619 - 2015-07-29
- FDA Inspection 848182 - 2013-09-13
- FDA Inspection 795373 - 2012-08-15
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