FDA Inspection
VitalantVitalant – FDA Inspection, Feb 7, 2025
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on February 7, 2025, issued by the Denver District Office, covering biologics.
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ID · 0b50350d-47a3-4b0c-b277-0019e1b87e73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260274
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.40Clean & orderly
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
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Other FDA inspections of Vitalant
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2017 | VAI | 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 1106655 - 2019-09-24
- FDA Inspection 1023598 - 2017-08-31
- FDA Inspection 983419 - 2015-10-20
- FDA Inspection 900184 - 2014-10-07
- FDA Inspection 854496 - 2013-09-30
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