Institute for Human Reproduction (IHR), SC – FDA 483, Oct 25, 2023

The Institute for Human Reproduction (IHR), Sc, a reproductive facility in Chicago, IL, was cited for significant deficiencies in its human cells, tissues, and cellular and tissue-based products (HCT/P) donor eligibility and quarantine procedures. Observations included failure to quarantine HCT/Ps with incomplete donor screening, determining donors eligible despite communicable disease risk factors, and lacking proper documentation and procedures for donor screening and eligibility. These issues indicate a serious lack of control over critical processes for ensuring HCT/P safety.