FDA 483 - Predictive Biotech, Inc. - June 11, 2021

Predictive Biotech, a stem cell manufacturer in Salt Lake City, UT, was cited for significant deficiencies in its manufacturing processes for injectable umbilical cord and amniotic membrane products. The inspection revealed a lack of aseptic process validation, inadequate investigation of sterility failures, and insufficient donor screening and eligibility determination. These issues raise serious concerns regarding the sterility, quality, and safety of the distributed products.