FDA 483 - Utah Cord Bank LLC - January 06, 2023

An FDA inspection of Utah Cord Bank LLC in Sandy, UT, revealed significant deficiencies in the control of storage areas for human umbilical cord blood and tissue products. The firm lacked an inventory system and corresponding Standard Operating Procedures to prevent mix-ups, contamination, and improper distribution of these critical HCT/Ps. This indicates a serious lack of control over product accountability and storage conditions.