FDA 483 - West Coast Fertility Centers, LLC - June 05, 2023

West Coast Fertility Centers, LLC, an HCT/P Reproductive Tissue Establishment in Fountain Valley, CA, was cited for deficiencies in donor screening during an FDA inspection. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, specifically syphilis, using an insufficient medical history interview form. This resulted in donors being deemed eligible without proper screening, and subsequent transfer of HCT/P tissues to recipients.