FDA 483 - The George Washington University Medical Faculty Associates Fertility and IVF Center - November 04, 2021

The George Washington University Medical Faculty Associates Fertility and IVF Center in Washington, DC, a reproductive human tissue establishment, was cited for multiple deficiencies during an FDA inspection. Observations primarily concerned inadequate donor screening procedures, improper donor eligibility determinations, and failures in record-keeping and labeling for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps). These issues indicate a lack of robust controls to ensure donor safety and proper handling of HCT/Ps.