FDA Inspection
VitalantVitalant – FDA Inspection, Nov 8, 2016
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on November 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Debra L. Boyd Seale (Issuing Officer)
- Jayne E Holcomb (Issuing Officer)
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ID · ac339770-3878-4491-88d0-23347b58d599
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014839
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Written SOPs available for use by personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitalant
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 2, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1320244 - 2026-05-29
- FDA Inspection 1201540 - 2023-03-02
- FDA Inspection 1074771 - 2018-12-04
- FDA Inspection 907184 - 2014-12-16
- FDA Inspection 807329 - 2012-11-14
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