FDA 483 - California Fertility Clinics LLC - June 12, 2025

California Fertility Clinics LLC in Los Angeles, an HCT/P Reproductive Establishment, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in procedures for determining donor eligibility, specifically regarding testing and interpretation for West Nile Virus. Additionally, the firm lacked a properly maintained and documented standard operating procedure for the release of HCT/Ps from donors reactive for cytomegalovirus, including inadequate retesting protocols and recipient risk communication.