FDA Inspection
Staten Island University Hospital Northwell HealthStaten Island University Hospital Northwell Health – FDA Inspection, Mar 4, 2010
Record Details
This FDA Inspection record concerns Staten Island University Hospital Northwell Health, with an inspection on March 4, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 4, 2010
- Product Type
- Biologics
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ID · efb6e616-d66d-432d-8904-c28b4ae8705d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649252
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| December 14, 2011 | 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 756348 - 2011-12-14
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