FDA Inspection
Mount Sinai Beth Israel Med Center, Ralph Gore Blood BankMount Sinai Beth Israel Med Center, Ralph Gore Blood Bank – FDA Inspection, Oct 19, 2010
Record Details
This FDA Inspection record concerns Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank, with an inspection on October 19, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 19, 2010
- Product Type
- Biologics
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ID · b554dbbc-9930-4e07-8376-67adff943597
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685308
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(21)Donor 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 |
| December 22, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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