FDA 483 - University Reproductive Associates, P.C. - January 19, 2023

An FDA inspection of University Reproductive Associates, P.C. in Hasbrouck Heights, NJ, a human tissue reproductive establishment, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, including West Nile Virus and Zika Virus. Additionally, the facility's written procedures were not designed to ensure compliance with donor eligibility requirements, lacking specific screening protocols for several infectious agents.