FDA Inspection
Mount Sinai Beth Israel Med Center, Ralph Gore Blood BankMount Sinai Beth Israel Med Center, Ralph Gore Blood Bank – FDA Inspection, Jul 31, 2012
Record Details
This FDA Inspection record concerns Mount Sinai Beth Israel Med Center, Ralph Gore Blood Bank, with an inspection on July 31, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 31, 2012
- Product Type
- Biologics
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ID · a48ee5aa-1632-443f-b58f-8febfbb20532
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791325
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 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 |
|---|---|---|---|
| September 4, 2014 | 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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