FDA 483 - Manhattan Reproductive Medicine, PC - February 12, 2020

Manhattan Reproductive Medicine,PC, a reproductive human tissue establishment in New York, NY, was cited for two observations during an FDA inspection. The firm failed to adequately screen oocyte donors for all relevant communicable disease risk factors, specifically concerning Zika virus (ZIKV) exposure. Additionally, the company lacked established and maintained procedures for screening and determining the eligibility of HCT/P donors.