FDA Inspection
New York Methodist HospitalNew York Methodist Hospital – FDA Inspection, Jan 23, 2009
Record Details
This FDA Inspection record concerns New York Methodist Hospital, with an inspection on January 23, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- New York Methodist Hospital
- Inspection Date
- January 23, 2009
- Product Type
- Biologics
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ID · b4ea280f-b0e4-4305-8e9c-ac5f3d2b6247
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 555804
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 600.14(c)When to report
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 640.3(a)Donor suitability not performed on day of collection
- 21 CFR 606.40Clean & orderly
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of New York Methodist Hospital
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York Methodist Hospital
- FDA Inspection 837792 - 2013-06-26
- FDA Inspection 712280 - 2011-03-03
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