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FDA Inspection
•Cooper Institute for Advanced Reproductive Medicine•December 9, 2022

Cooper Institute for Advanced Reproductive Medicine – FDA Inspection, Dec 9, 2022

Record Details

This FDA Inspection record concerns Cooper Institute for Advanced Reproductive Medicine, with an inspection on December 9, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Cooper Institute for Advanced Reproductive Medicine
Inspection Date
December 9, 2022
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 76cd6431-6f1e-450d-91a7-c05c26d65be1

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1192782
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

Other FDA inspections of Cooper Institute for Advanced Reproductive Medicine

5
DateClassificationOfficeProject area
October 29, 2025Not classifiedDallas District OfficeHuman Cellular, Tissue, and Gene Therapies
November 16, 2023OAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
July 19, 2021OAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 26, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 22, 2014VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Cooper Institute for Advanced Reproductive Medicine
  • FDA Inspection 1289322 - 2025-10-29
  • FDA Inspection 1223634 - 2023-11-16
  • FDA Inspection 1146456 - 2021-07-19
  • FDA Inspection 1017306 - 2017-04-26
  • FDA Inspection 907753 - 2014-12-22

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