FDA 483 - Dr. Louis R. Manara - January 28, 2020

An FDA inspection of Dr. Louis R. Manara, a human tissue reproductive establishment in Voorhees, NJ, revealed critical failures in donor screening. The firm did not adequately test oocyte donors for communicable disease agents and failed to deem ineligible a donor who tested positive for Chlamydia trachomatis, leading to the use and banking of embryos from this donor.