FDA 483 - VCU Health System Reproductive Medicine and IVF - November 14, 2024

VCU Health System Reproductive Medicine and IVF, an HCT/Ps establishment, was cited for failing to properly screen donors for communicable disease risk factors. Specifically, the firm determined a directed donor to be eligible despite the donor's response to a medical history question indicating a risk factor. This lapse in screening could compromise the safety of donated HCT/Ps.