FDA 483 - Fertility Care of Orange County, A Medical Corporation - October 07, 2024

An FDA inspection of Fertility Care of Orange County, A Medical Corporation, an HCT/P reproductive establishment in Brea, CA, revealed a significant deficiency in donor screening. The firm failed to adequately screen donors for communicable disease agents such as West Nile Virus, Creutzfeldt-Jacob Disease, and xenotransplantation risks. This lapse in screening could compromise the safety of human cells, tissues, and cellular and tissue-based products.