FDA Inspection
VitalantVitalant – FDA Inspection, May 22, 2013
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on May 22, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- May 22, 2013
- Product Type
- Biologics
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ID · e75f9568-dd2b-478f-8026-085eb7a24555
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 825227
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Vitalant
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 30, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 14, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 30, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1229052 - 2024-01-31
- FDA Inspection 1084078 - 2019-03-08
- FDA Inspection 981014 - 2016-06-30
- FDA Inspection 948428 - 2015-10-14
- FDA Inspection 910467 - 2015-01-30
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