FDA 483 - VCU Health System Reproductive Medicine and IVF - May 12, 2023

VCU Health System Reproductive Medicine and IVF in Richmond, VA, received a Form FDA 483 with three observations during an inspection of its Reproductive HCT/P operations. The observations primarily concern deficiencies in donor eligibility determinations and record-keeping practices. Issues included the absence of summary records for HCT/Ps, failure to interpret infectious disease test results, and inadequate documentation of reasons for donor ineligibility.