FDA 483 - Manhattan Fertility Services LLC - April 06, 2023

Manhattan Fertility Services LLC, a human reproductive tissue establishment in New York, was cited for two observations during an FDA inspection. The firm failed to adequately screen semen donors for communicable disease risk factors, specifically Zika Virus. Additionally, HCT/Ps from ineligible donors, who tested positive for Hepatitis B, were not properly labeled with warning statements.