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

An FDA inspection of NCFMC, a Medical Corporation, a human reproductive tissue establishment in Sacramento, CA, revealed significant deficiencies in donor eligibility determinations and communicable disease testing. The firm failed to deem ineligible donors with risk factors and did not follow manufacturer instructions for testing. Additionally, the inspection found inadequate and inconsistent written procedures for donor eligibility, risk factor management, and record review.