FDA 483 - Regional Women's Health Group, LLC - July 12, 2019

An FDA inspection of Regional Women's Health Group, LLC, a human tissue reproductive establishment in Marlton, NJ, revealed two significant observations. The firm failed to adequately test oocyte donors for relevant communicable disease agents, specifically West Nile Virus. Additionally, donors were not properly screened for risk factors of communicable diseases, including the Zika Virus.