FDA 483 - Dr. Louis R. Manara - May 23, 2023

An FDA inspection of Dr. Louis R. Manara, Practice Owner, in Voorhees, NJ, from May 16-23, 2023, identified one observation. The firm failed to determine donors ineligible despite the presence of risk factors for communicable disease agents. Specifically, five directed semen donors with risk factors, including men who have had sex with another man in the preceding 5 years, were deemed eligible.