FDA Inspection
Cooper Institute for Advanced Reproductive MedicineCooper Institute for Advanced Reproductive Medicine – FDA Inspection, Nov 16, 2023
Record Details
This FDA Inspection record concerns Cooper Institute for Advanced Reproductive Medicine, with an inspection on November 16, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 16, 2023
- Product Type
- Biologics
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ID · 5ecd4332-c452-40e9-8ec4-fffebe53af6a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1223634
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
Other FDA inspections of Cooper Institute for Advanced Reproductive Medicine
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2025 | Not classified | Dallas District Office | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2022 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 19, 2021 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 26, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 22, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cooper Institute for Advanced Reproductive Medicine
- FDA Inspection 1289322 - 2025-10-29
- FDA Inspection 1192782 - 2022-12-09
- FDA Inspection 1146456 - 2021-07-19
- FDA Inspection 1017306 - 2017-04-26
- FDA Inspection 907753 - 2014-12-22
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