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FDA Inspection
•North Shore Fertility, SC•May 29, 2012

North Shore Fertility, SC – FDA Inspection, May 29, 2012

Record Details

This FDA Inspection record concerns North Shore Fertility, SC, with an inspection on May 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
North Shore Fertility, SC
Inspection Date
May 29, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 5e4dd6cf-b4f1-4121-b19a-c4844f0d329b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
782652
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  2. 21 CFR 1271.260(a)Contamination, mix ups, improper release

Full citation text and observation details available on the Dashboard.

Other FDA inspections of North Shore Fertility, SC

5
DateClassificationOfficeProject area
July 7, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
August 26, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 30, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 8, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 13, 2010NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for North Shore Fertility, SC
  • FDA Inspection 1017961 - 2017-07-07
  • FDA Inspection 940167 - 2015-08-26
  • FDA Inspection 878232 - 2014-04-30
  • FDA Inspection 729792 - 2011-06-08
  • FDA Inspection 682626 - 2010-09-13

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