FDA Inspection
Montefiore New RochelleMontefiore New Rochelle – FDA Inspection, Nov 10, 2009
Record Details
This FDA Inspection record concerns Montefiore New Rochelle, with an inspection on November 10, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Montefiore New Rochelle
- Inspection Date
- November 10, 2009
- Product Type
- Biologics
View Company Profile
ID · ae25e50d-a84e-4147-a46c-c5488b6d823e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 622870
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 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 Montefiore New Rochelle
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 15, 2012 | 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 794496 - 2012-08-15
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