FDA 483 - Cincinnati Childrens Hospital Medical Center Division of Gynecology - July 12, 2023

An FDA inspection of Cincinnati Childrens Hospital Medical Center Division of Gynecology in Cincinnati, OH, revealed significant deficiencies in their screening and testing of ovarian tissue donors. The firm used unapproved test kits for communicable disease agents and failed to adequately screen donors for risk factors of communicable diseases, including missing critical questions on donor history questionnaires. These issues indicate a failure to ensure the safety and eligibility of donated reproductive tissue.