FDA 483 - Ohio Fertility Providers LLC - May 15, 2025

An FDA inspection of Ohio Fertility Providers LLC in Cincinnati, OH, revealed two significant observations regarding the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was complete and did not properly label HCT/Ps with incomplete donor history questionnaires with required warning statements, potentially exposing recipients to risks.