FDA 483 - Northern California Fertility Medical Center - August 19, 2025

An FDA inspection of NCFMC, a Medical Corporation, identified significant deficiencies in its human reproductive tissue establishment. The firm failed to properly determine donor eligibility, particularly concerning communicable disease risk factors, and did not adhere to manufacturer's instructions for disease agent testing. Furthermore, NCFMC lacked comprehensive and consistent written procedures for donor screening, eligibility, and the donation of various reproductive tissues.