Michigan Reproductive and IVF Center, PLLC – FDA 483, Jun 3, 2026
Michigan Reproductive and IVF Center, PLLC in Grand Rapids, MI, was cited for multiple deficiencies related to human cells, tissues, and cellular and tissue-based products (HCT/P) donor eligibility. The inspection revealed significant issues with donor screening procedures, incomplete medical record reviews for communicable diseases, and inaccurate or undocumented eligibility determinations. These findings indicate a serious lack of control over the safety and suitability of donated reproductive tissues.
ID · 32412764-4232-40be-b9c1-50994545ef27
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