FDA Inspection
Mount Sinai WestMount Sinai West – FDA Inspection, Oct 9, 2015
Record Details
This FDA Inspection record concerns Mount Sinai West, with an inspection on October 9, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Mount Sinai West
- Inspection Date
- October 9, 2015
- Product Type
- Biologics
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ID · fcff5fc4-8924-46cc-94e2-cdcd811d7668
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944902
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.170(b)Adverse reaction - fatality
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Other FDA inspections of Mount Sinai West
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 19, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 7, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mount Sinai West
- FDA Inspection 1034681 - 2017-11-21
- FDA Inspection 867589 - 2014-02-26
- FDA Inspection 753222 - 2011-11-14
- FDA Inspection 720387 - 2011-04-19
- FDA Inspection 580613 - 2009-05-07
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