FDA Inspection
VitalantVitalant – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on September 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- September 13, 2013
- Product Type
- Biologics
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ID · 5be7f3d8-d2f0-469e-bae3-e9abd3f4563d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848182
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.160(b)Required records
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
Full citation text and observation details available on the Dashboard.
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 |
| February 10, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 29, 2015 | NAI | 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 1000905 - 2017-02-10
- FDA Inspection 937619 - 2015-07-29
- FDA Inspection 795373 - 2012-08-15
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