FDA Inspection
Mount Sinai Beth Israel Med Center, Ralph Gore Blood BankMount Sinai Beth Israel Med Center, Ralph Gore Blood Bank – FDA Inspection, Dec 22, 2008
Record Details
This FDA Inspection record concerns Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank, with an inspection on December 22, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 22, 2008
- Product Type
- Biologics
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ID · 4f8340db-5672-483b-9c79-b6d2c7b256be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 549990
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(a)SOP compliance
- 21 CFR 630.40(d)(1)Physician notification
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Other FDA inspections of Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 19, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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