FDA 483 - Institute for Reproductive Health - August 30, 2023

An FDA inspection of Institute for Reproductive Health in Cincinnati, OH, revealed significant deficiencies in their donor screening process for communicable disease agents. The firm's donor history questionnaire for oocyte donors was found to be inadequate, failing to properly address risk factors for conditions such as Creutzfeldt-Jacob disease and Zika virus. This indicates a failure to ensure the safety of human cells, tissues, and cellular and tissue-based products (HCT/Ps).