FDA 483 - Zhang Medical P.C. d/b/a New Hope Fertility Center - September 15, 2014

An FDA inspection of New Hope Fertility Center, a reproductive human tissue establishment in New York, NY, revealed significant deficiencies in donor eligibility determination and associated procedures. The firm failed to properly screen and test oocyte donors, including accepting a donor positive for chlamydia and not collecting specimens at appropriate times. Additionally, there were widespread issues with incomplete physical exams, missing documentation for eligibility determinations, and inadequate written procedures for all steps of donor screening and testing.