Palo Alto Medical Foundation Fertility Physicians of Northern California – FDA 483, Jun 18, 2026

Palo Alto Medical Foundation Reproductive Endocrinology and Infertility in San Jose, CA, was inspected regarding its human reproductive tissue operations. The inspection revealed significant deficiencies in donor screening processes, specifically concerning communicable disease risk factors. The firm failed to adequately screen donors using flawed questionnaires and subsequently determined ineligible donors to be eligible, resulting in the transfer of potentially unsafe reproductive tissues.