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FDA Inspection
•Reproductive Genetics and Fertility Centers PLLC•April 24, 2015

Reproductive Genetics and Fertility Centers PLLC – FDA Inspection, Apr 24, 2015

Record Details

This FDA Inspection record concerns Reproductive Genetics and Fertility Centers PLLC, with an inspection on April 24, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Reproductive Genetics and Fertility Centers PLLC
Inspection Date
April 24, 2015
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 9d94e451-eaba-47f1-89f1-6bc414e4d075

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
923218
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 1271.47(b)Review and approval of procedures
  2. 21 CFR 1271.80(b)Specimen collections not timely

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Reproductive Genetics and Fertility Centers PLLC

3
DateClassificationOfficeProject area
August 3, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 10, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
August 26, 2011VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Reproductive Genetics and Fertility Centers PLLC
  • FDA Inspection 981953 - 2016-08-03
  • FDA Inspection 834878 - 2013-06-10
  • FDA Inspection 744498 - 2011-08-26

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