FDA Inspection
GenesiscareGenesiscare – FDA Inspection, Mar 12, 2018
Record Details
This FDA Inspection record concerns Genesiscare, with an inspection on March 12, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 77f99a8c-7605-4dfe-9587-8c9eafce9271
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044785
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 600.15Blood & Blood Components
- 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 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 |
| December 17, 2015 | 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 954425 - 2015-12-17
- FDA Inspection 879728 - 2014-05-23
- FDA Inspection 776722 - 2012-04-13
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