Utah Cord Bank LLC dba Utah Cell Bank
FDA issued a Warning Letter to Utah Cord Bank LLC dba Utah Cell Bank (owner Eliott D. Spencer, PhD) following a February 2021 inspection of its Sandy, Utah facility, finding that its allogeneic cellular products—StemVive®, StemMaxx™, StemTru™, and StemCellect™—derived from umbilical cord blood, cord tissue, and amniotic membrane, are unapproved biological drugs marketed without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria required for regulation solely under section 361 of the PHS Act, and the inspection documented 14 significant CGMP/CGTP deviations including unvalidated aseptic processes, 16 uninvestigated sterility failures, and inadequate batch records. FDA warned that failure to adequately address these violations may result in seizure and/or injunction, and required a written response within 15 working days.
Flagged claims (2)
your products are intended to treat various diseases or conditions
using these products to treat orthopedic conditions, for example, is not homologous use as defined in 21 CFR 1271.3(c)
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
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