FDA Inspection
Coney Island HospitalConey Island Hospital – FDA Inspection, Oct 21, 2009
Record Details
This FDA Inspection record concerns Coney Island Hospital, with an inspection on October 21, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Coney Island Hospital
- Inspection Date
- October 21, 2009
- Product Type
- Biologics
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ID · b6fffad8-9f5f-4ae7-8ab4-eee101fe17ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 621609
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 630.40(b)(3)Results of testing
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Coney Island Hospital
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Coney Island Hospital
- FDA Inspection 837419 - 2013-06-19
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