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

An FDA inspection of Johns Hopkins Fertility Center in Lutherville, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen oocyte donors for communicable disease risk factors and did not include the establishment's address in the summary of records for HCT/Ps donor eligibility determinations. These issues indicate a failure to ensure the safety and proper documentation of human tissue products.