FDA 483 - Stem Cell Cryo Bank, LLC / SFBMSCTI - May 01, 2025

An FDA inspection of Stem Cell Cryo Bank, LLC in Deerfield Beach, FL, a human umbilical cord blood establishment, revealed two significant observations. The firm failed to establish procedures to validate and approve processes, specifically the aseptic process for human umbilical cord blood units. Additionally, the quality program lacked procedures for investigating HCT/P deviations, including positive processing samples.