FDA Inspection
New York Blood Center EnterprisesNew York Blood Center Enterprises – FDA Inspection, Sep 4, 2009
Record Details
This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on September 4, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 4, 2009
- Product Type
- Biologics
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ID · fce35dfa-c736-45ef-b9cf-947ed40e7333
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605242
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 820.75(a)Documentation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of New York Blood Center Enterprises
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2026 | Not classified | New York District Office | Blood and Blood Products |
| October 27, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 22, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 29, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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