FDA 483 - Chelsea Fertility NYC - October 11, 2022

An FDA inspection of Chelsea Fertility NYC, a reproductive human tissue establishment, revealed critical deficiencies in donor screening and record-keeping. The firm failed to adequately screen oocyte donors for communicable disease risks, including West Nile Virus and Creutzfeldt-Jakob disease, and improperly deemed an ineligible donor as eligible despite positive infectious disease markers. Additionally, the facility lacked established procedures for donor screening and maintained inaccurate or illegible donor eligibility records.