FDA 483 - Dr. Louis R. Manara - October 21, 2021

An FDA inspection of Dr. Louis R. Manara, a human tissue reproductive establishment in Voorhees, NJ, revealed a significant deficiency in donor screening. The firm failed to test anonymous oocyte donors for relevant communicable disease agents, specifically West Nile Virus, before deeming them eligible to donate. This indicates a serious lapse in ensuring donor safety and compliance with regulations for human tissue products.