FDA Inspection
South Nassau Communities HospitalSouth Nassau Communities Hospital – FDA Inspection, Jun 4, 2010
Record Details
This FDA Inspection record concerns South Nassau Communities Hospital, with an inspection on June 4, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 4, 2010
- Product Type
- Biologics
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ID · de8c00f6-21c8-4219-9106-d08f5be53560
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667716
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 630.40(b)(2)Type of donations
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 630.40(d)(1)Physician notification
- 21 CFR 600.12(a)Maintenance - concurrence
- 21 CFR 600.12(a)Maintenance - completeness
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of South Nassau Communities Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for South Nassau Communities Hospital
- FDA Inspection 984313 - 2016-08-23
- FDA Inspection 974958 - 2016-06-29
- FDA Inspection 875482 - 2014-04-21
- FDA Inspection 778439 - 2012-05-01
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