FDA 483 - Give Legacy - December 01, 2021

An FDA inspection of Kokopelli Technologies, dba Embryodirector.com, in San Antonio, TX, identified a significant issue regarding the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, Sexually Intimate Partner (SIP) semen samples intended for autologous use were not properly labeled "For Autologous Use Only" and "Not Evaluated for Infectious Substances," and donor eligibility determinations were not performed for these samples prior to storage and shipment to cryo-preservation banks. This indicates a failure to ensure appropriate controls for HCT/Ps.