Utah Cord Bank Hit with Warning Letter

A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) in Sandy, UT, has determined that the firm’s cell products StemVive and StemMaxx are unapproved. A just-posted Warning Letter says that agency investigators also documented evidence of significant GMP and good tissue practice deviations. For example, the Utah Cord Bank failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes. Additionally, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.