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 in Brea, CA, identified a critical deficiency in donor screening practices. The firm failed to adequately screen donors for communicable disease agents and diseases, including West Nile Virus, Creutzfeldt-Jacob Disease, and xenotransplantation risks. This was due to an incomplete medical and social screening questionnaire, indicating a significant compliance issue.