FDA 483 - North Hudson IVF Center for Fertility & Gynecology P.C. - March 03, 2022

North Hudson IVF Center for Fertility & Gynecology P.C. in Englewood Cliffs, NJ, was cited with a Form 483 following an inspection of its human reproductive tissue establishment. The firm failed to adequately screen oocyte donors for communicable disease risks, including Zika and West Nile Viruses. Additionally, the facility lacked established and maintained procedures for HCT/P donor testing, screening, and eligibility determination.