FDA Inspection
VitalantVitalant – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on August 31, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c8553192-e482-4b1e-a440-ff659ded7821
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023598
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 640.31Donor eligibility
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 |
|---|---|---|---|
| February 7, 2025 | VAI | Denver District Office | Blood and Blood Products |
| September 24, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 7, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1260274 - 2025-02-07
- FDA Inspection 1106655 - 2019-09-24
- FDA Inspection 983419 - 2015-10-20
- FDA Inspection 900184 - 2014-10-07
- FDA Inspection 854496 - 2013-09-30
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