FDA Inspection
Vitalant Reference and Transfusion ServiceVitalant Reference and Transfusion Service – FDA Inspection, Aug 5, 2019
Record Details
This FDA Inspection record concerns Vitalant Reference and Transfusion Service, with an inspection on August 5, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b71aa00a-ccc5-427c-bb21-b6a3afa8e1ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098877
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitalant Reference and Transfusion Service
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 28, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 7, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant Reference and Transfusion Service
- FDA Inspection 1241647 - 2024-06-13
- FDA Inspection 1019105 - 2017-07-17
- FDA Inspection 928230 - 2015-05-28
- FDA Inspection 817490 - 2013-02-07
- FDA Inspection 707706 - 2011-01-25
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