FDA 483 - Utah Cord Bank LLC - February 11, 2021

Utah Cord Bank LLC received a Form 483 for significant deficiencies in its manufacturing processes for human umbilical cord blood, tissue, and amniotic tissue products, including StemVive, StemMaxx, StemTru, and StemCellect. The observations highlight a lack of validated aseptic processes, inadequate complaint handling, insufficient environmental monitoring, and failures in donor screening and testing for communicable diseases, particularly Zika virus. These issues raise concerns about the sterility, quality, and purity of their purported sterile injectable products and HCT/Ps.