FDA 483 - San Diego Fertility Center, Medical Group Inc - May 26, 2023

An FDA inspection of San Diego Fertility Center, Medical Group, Inc, a human reproductive tissue establishment, identified a significant deficiency in donor screening practices. The firm failed to adequately screen donors for communicable disease agents and diseases. This included missing critical risk factors for West Nile Virus, HIV group O, and xenotransplantation exposure on their donor medical history questionnaire.