FDA Inspection
GenesiscareGenesiscare – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Genesiscare, with an inspection on February 24, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Genesiscare
- Inspection Date
- February 24, 2010
- Product Type
- Biologics
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ID · db1e2db6-092a-48ac-966c-e5c005bffa07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649953
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.165(c)Receipt records - content
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 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 |
| March 12, 2018 | 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 |
Other documents for Genesiscare
- FDA Inspection 1203825 - 2023-04-18
- FDA Inspection 1119798 - 2020-02-25
- FDA Inspection 1044785 - 2018-03-12
- FDA Inspection 954425 - 2015-12-17
- FDA Inspection 879728 - 2014-05-23
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