FDA Inspection
New York- Presbyterian/QueensNew York- Presbyterian/Queens – FDA Inspection, Jan 31, 2014
Record Details
This FDA Inspection record concerns New York- Presbyterian/Queens, with an inspection on January 31, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 31, 2014
- Product Type
- Biologics
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ID · 95d13d1b-03e1-4178-bea0-2e1738806edd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862238
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 600.14(c)When to report
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.40(a)(1)Provide space for examination
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Other FDA inspections of New York- Presbyterian/Queens
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York- Presbyterian/Queens
- FDA Inspection 964372 - 2016-01-29
- FDA Inspection 756843 - 2011-12-16
- FDA Inspection 637009 - 2010-01-13
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