483
Reproductive Medicine InstituteReproductive Medicine Institute – FDA 483, Jun 9, 2026
Record Details
Reproductive Medicine Institute in Oak Brook, IL, a reproductive clinic, was cited for a significant labeling deficiency during an FDA inspection. The firm failed to prominently label donated fertilized oocytes (HCT/Ps) with required warning statements regarding communicable disease risk, particularly for those where donor eligibility determination was not required. This issue affected numerous reproductive tissues transferred between January 2024 and May 2026.
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ID · 63b9cddc-6be2-46f0-bf1d-13ec57a413ba
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