FDA Inspection
Montefiore New RochelleMontefiore New Rochelle – FDA Inspection, Aug 15, 2012
Record Details
This FDA Inspection record concerns Montefiore New Rochelle, with an inspection on August 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Montefiore New Rochelle
- Inspection Date
- August 15, 2012
- Product Type
- Biologics
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ID · 6d516510-aee5-452f-8866-b8e14150a21c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794496
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)(19)Procedure for HIV or HCV lookback
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Other FDA inspections of Montefiore New Rochelle
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 10, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Montefiore New Rochelle
- FDA Inspection 866376 - 2014-02-18
- FDA Inspection 622870 - 2009-11-10
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