FDA Inspection
New York- Presbyterian/QueensNew York- Presbyterian/Queens – FDA Inspection, Jan 13, 2010
Record Details
This FDA Inspection record concerns New York- Presbyterian/Queens, with an inspection on January 13, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 13, 2010
- Product Type
- Biologics
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ID · 73dc9a91-22cd-4d16-86f8-d2a6fd9f463a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637009
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| January 31, 2014 | 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 |
Other documents for New York- Presbyterian/Queens
- FDA Inspection 964372 - 2016-01-29
- FDA Inspection 862238 - 2014-01-31
- FDA Inspection 756843 - 2011-12-16
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