FDA Inspection
VitalantVitalant – FDA Inspection, Nov 30, 2012
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on November 30, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- November 30, 2012
- Product Type
- Biologics
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ID · 4951a433-1e6c-4ae3-b79d-2e61b28f821e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808877
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 640.31(b)Criteria for plasmapheresis donor eligibility
- 21 CFR 640.31Donor eligibility
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(b)Required records
- 21 CFR 211.194(a)(8)Second person sign off
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Other FDA inspections of Vitalant
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 16, 2016 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| April 15, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1251496 - 2024-08-02
- FDA Inspection 1118232 - 2020-01-10
- FDA Inspection 1044582 - 2017-12-15
- FDA Inspection 980906 - 2016-06-16
- FDA Inspection 923869 - 2015-04-15
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