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