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FDA Inspection
•Michigan Reproductive and IVF Center, PLLC•June 3, 2026

Michigan Reproductive and IVF Center, PLLC – FDA Inspection, Jun 3, 2026

Record Details

This FDA Inspection record concerns Michigan Reproductive and IVF Center, PLLC, with an inspection on June 3, 2026, issued by the Detroit District Office, covering biologics.

Company
Michigan Reproductive and IVF Center, PLLC
Inspection Date
June 3, 2026
Product Type
Biologics
Office
Detroit District Office
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · 865f9a24-b008-49f2-927a-52ff9f7ebd02

Inspection Facts

Inspection number
1320288
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  2. 21 CFR 1271.50(a)Determination based on screening and testing
  3. 21 CFR 1271.55(d)(2)Accurate, indelible, legible
  4. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  5. 21 CFR 1271.75(b)Risk factors, leukocyte-rich cells or tissues

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Michigan Reproductive and IVF Center, PLLC

6
DateClassificationOfficeProject area
April 27, 2023VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 19, 2019NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 9, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 10, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 18, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Michigan Reproductive and IVF Center, PLLC
  • FDA Inspection 1203780 - 2023-04-27
  • FDA Inspection 1105255 - 2019-09-19
  • FDA Inspection 1051882 - 2018-03-09
  • FDA Inspection 960942 - 2016-02-10
  • FDA Inspection 825770 - 2013-03-18

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