FDA 483 - National Embryo Donation Center - January 12, 2023

The FDA inspected National Embryo Donation Center in Knoxville, TN, from January 10-12, 2023, regarding its reproductive establishment. A significant issue was identified where human cells, tissues, and cellular and tissue-based products (HCT/Ps) from sexually-intimate partners lacked required warning statements on records. This deficiency occurred when communicable disease testing was performed after cryopreservation, indicating a failure to properly inform recipients about the timing of critical donor screening.