FDA 483 - Main Line Fertility Clinic P.C. - April 08, 2019

Regional Women's Health Group LLC in Abington, PA, was cited for deficiencies in its human tissue reproductive establishment. The inspection revealed inadequate screening of oocyte donors for communicable disease agents, specifically the Zika Virus, by failing to assess all relevant risk factors. Additionally, issues were noted with HCT/P record-keeping, including the improper inclusion of anonymous donor names and the absence of required laboratory certification statements for communicable disease testing.