FDA 483 - Global Premier Fertility - Los Angeles, PC - December 08, 2025

An FDA inspection of Global Premier Fertility - Los Angeles, PC, a HCT/P Reproductive Establishment in Rolling Hills Estates, CA, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen donors for all required relevant communicable disease agents and diseases, including West Nile Virus and variant Creutzfeldt-Jakob Disease. Additionally, procedures were not designed to ensure compliance with donor eligibility requirements, and the interpretation of communicable disease test results was not consistently documented.