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FDA Inspection
•Midwest Fertility Specialists•January 31, 2013

Midwest Fertility Specialists – FDA Inspection, Jan 31, 2013

Record Details

This FDA Inspection record concerns Midwest Fertility Specialists, with an inspection on January 31, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Midwest Fertility Specialists
Inspection Date
January 31, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 743d1059-4366-4570-8556-850be169dc97

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
816819
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.55(d)(2)Accurate, indelible, legible
  2. 21 CFR 1271.90(c)Eligibility not required--warning labels
  3. 21 CFR 1271.55(c)Name and personal info on accompanying records
  4. 21 CFR 1271.50(a)Responsible person to determine, document

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Midwest Fertility Specialists

5
DateClassificationOfficeProject area
November 25, 2024VAIDetroit District OfficeHuman Cellular, Tissue, and Gene Therapies
October 16, 2019NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 21, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 18, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 19, 2010NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Midwest Fertility Specialists
  • FDA Inspection 1255000 - 2024-11-25
  • FDA Inspection 1109705 - 2019-10-16
  • FDA Inspection 1015921 - 2017-06-21
  • FDA Inspection 931253 - 2015-06-18
  • FDA Inspection 660527 - 2010-04-19

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