FDA 483 - Neway Medical, P.C. - March 27, 2019

American Fertility Services, P.C. in New York, NY, a reproductive HCT/P establishment, was cited for deficiencies in its donor screening processes. The firm failed to adequately screen oocyte donors for communicable disease risk factors, including Zika and West Nile Viruses. Additionally, procedures for determining donor eligibility were found to be outdated and not properly maintained or revised.