FDA Inspection
GenesiscareGenesiscare – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Genesiscare, with an inspection on December 17, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Genesiscare
- Inspection Date
- December 17, 2015
- Product Type
- Biologics
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ID · ec38b556-cf87-4f9d-8223-2884518e3fae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954425
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 600.15Blood & Blood Components
- 21 CFR 606.160(a)(1)Concurrent documentation
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Other FDA inspections of Genesiscare
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2020 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 12, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 23, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 13, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Genesiscare
- FDA Inspection 1203825 - 2023-04-18
- FDA Inspection 1119798 - 2020-02-25
- FDA Inspection 1044785 - 2018-03-12
- FDA Inspection 879728 - 2014-05-23
- FDA Inspection 776722 - 2012-04-13
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