FDA 483 - IVF/ART Laboratories/JHH at Green Spring Station - August 14, 2025

John Hopkins Fertility Center in Lutherville, MD, received a Form 483 with two observations during an inspection of its reproductive human tissue establishment. The firm failed to adequately screen oocyte donors for communicable disease risk factors due to a deficient medical history questionnaire. Additionally, the summary of records for HCT/Ps did not include the address of the establishment that made the donor-eligibility determination.