FDA Inspection
VitalantVitalant – FDA Inspection, May 7, 2012
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on May 7, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- May 7, 2012
- Product Type
- Biologics
View Company Profile
ID · 186a1948-7797-4c58-908a-d539a7ea1181
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780778
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.3(c)(1)History of viral hepatitis
- 21 CFR 606.100(c)Thorough investigations
- 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
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 28, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1257839 - 2024-12-20
- FDA Inspection 1180501 - 2022-09-20
- FDA Inspection 1042847 - 2018-02-05
- FDA Inspection 958214 - 2016-01-28
- FDA Inspection 867653 - 2014-02-25
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