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

The FDA issued a Warning Letter to Utah Cord Bank LLC (dba Utah Cell Bank) and FIOR Bioscience LLC following a February 1-11, 2021 inspection. The firms manufacture and distribute allogeneic human umbilical cord blood, umbilical cord, and amniotic membrane-derived cellular products (e.g., StemVive®, StemMaxx™, StemTru™, StemCellect™) intended for injection and purported sterility. The FDA determined these products are unapproved drugs and biological products under the FD&C Act and PHS Act, not solely regulated as HCT/Ps, because they are not for homologous use, are metabolically active, and are more than minimally manipulated.

The firms lack an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application. Significant deviations from CGMP and CGTP were observed, including: - Failure to validate aseptic processes and use sterile PPE. - Inadequate facility controls, including unclassified manufacturing environments, insufficient environmental monitoring, and lack of personnel monitoring. - Absence of scientifically sound specifications, sampling plans, and validated test procedures for product quality and sterility. - Failure to validate manufacturing processes and cleaning procedures for equipment. - Inadequate investigation of 16 sterility failures. - Lack of stability data to support assigned expiration dates. - Insufficient complaint handling procedures and documentation. - Incomplete batch production records. - Failure to establish time limits for