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FDA Inspection
•South Nassau Communities Hospital•April 21, 2014

South Nassau Communities Hospital – FDA Inspection, Apr 21, 2014

Record Details

This FDA Inspection record concerns South Nassau Communities Hospital, with an inspection on April 21, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
South Nassau Communities Hospital
Inspection Date
April 21, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · dbbff998-e293-45d5-9e46-29ae54d20e46

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
875482
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.160(b)Required records
  2. 21 CFR 606.160(a)(1)Concurrent documentation
  3. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of South Nassau Communities Hospital

4
DateClassificationOfficeProject area
August 23, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 29, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 1, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 4, 2010VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for South Nassau Communities Hospital
  • FDA Inspection 984313 - 2016-08-23
  • FDA Inspection 974958 - 2016-06-29
  • FDA Inspection 778439 - 2012-05-01
  • FDA Inspection 667716 - 2010-06-04

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