FDA Inspection
Staten Island University Hospital Northwell HealthStaten Island University Hospital Northwell Health – FDA Inspection, Dec 14, 2011
Record Details
This FDA Inspection record concerns Staten Island University Hospital Northwell Health, with an inspection on December 14, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 14, 2011
- Product Type
- Biologics
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ID · e949526f-e36a-49f5-84e7-dabf119a706b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756348
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)(6)Methods of component preparation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Staten Island University Hospital Northwell Health
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 4, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 5, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 4, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Staten Island University Hospital Northwell Health
- FDA Inspection 1116042 - 2020-01-16
- FDA Inspection 1034697 - 2017-10-04
- FDA Inspection 911772 - 2015-02-05
- FDA Inspection 807499 - 2012-11-19
- FDA Inspection 649252 - 2010-03-04
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