FDA 483 - IVF/ART Laboratories/JHH at Green Spring Station - October 24, 2022

An FDA inspection of IVF/ART Laboratories/JHH at Green Spring Station in Lutherville, MD, identified two observations related to donor screening and eligibility for anonymous oocyte donors. The firm failed to adequately screen donors for communicable disease risk factors, specifically Zika virus, and determined donor eligibility before infectious disease testing results were available.