FDA Inspection
VitalantVitalant – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on August 23, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · ac9566f8-0243-4802-a723-05d877396335
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100311
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitalant
16| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | Not classified | Philadelphia District Office | |
| December 1, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 4, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1281129 - 2025-09-04
- FDA Inspection 1193237 - 2022-12-01
- FDA Inspection 1106128 - 2019-06-28
- FDA Inspection 1102324 - 2019-06-28
- FDA Inspection 962753 - 2016-03-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.