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FDA Inspection
•Michigan Comprehensive Fertility Center, PLLC•July 26, 2017

Michigan Comprehensive Fertility Center, PLLC – FDA Inspection, Jul 26, 2017

Record Details

This FDA Inspection record concerns Michigan Comprehensive Fertility Center, PLLC, with an inspection on July 26, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Michigan Comprehensive Fertility Center, PLLC
Inspection Date
July 26, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Erma Zaimova
View Company Profile

ID · e738c135-4d68-489c-8a17-918e5a3499ba

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1019285
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Michigan Comprehensive Fertility Center, PLLC

3
DateClassificationOfficeProject area
June 3, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 13, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 3, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Michigan Comprehensive Fertility Center, PLLC
  • FDA Inspection 929130 - 2015-06-03
  • FDA Inspection 819199 - 2013-02-13
  • FDA Inspection 712393 - 2011-03-03

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