Give Legacy – FDA 483, Dec 1, 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.
ID · 41898845-2f64-4aa7-ae83-dcb379a6a12d
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.