FDA 483 - North Hudson IVF Center for Fertility & Gynecology P.C. - July 02, 2024

North Hudson IVF Center for Fertility & Gynecology, P.C. in Englewood Cliffs, NJ, a human reproductive tissue establishment, was cited for significant deficiencies in its donor screening and record-keeping practices. The inspection revealed inadequate screening for communicable disease risk factors in oocyte donors and incomplete summaries of communicable disease test results for HCT/Ps. Furthermore, the firm lacked established and maintained procedures for donor testing, screening, and eligibility determination.