FDA Inspection
Mount Sinai Beth Israel Med Center, Ralph Gore Blood BankMount Sinai Beth Israel Med Center, Ralph Gore Blood Bank – FDA Inspection, Sep 4, 2014
Record Details
This FDA Inspection record concerns Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank, with an inspection on September 4, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 4, 2014
- Product Type
- Biologics
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ID · ef3c11b0-e58a-443d-bbca-bfa1bee9878b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893412
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 22, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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