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Utah Cord Bank LLC manufactured and distributed cellular products derived from human umbilical cord blood, umbilical cord, and amniotic membrane (branded as StemVive®, StemMaxx™, StemTru™, and StemCellect™) that were marketed for treating various diseases and conditions, thereby qualifying them as drugs and biologics subject to FDA regulation under 21 CFR Part 1271. During a February 2021 inspection, FDA investigators documented deviations from current good manufacturing practice and regulations governing human cells, tissues, and cellular or tissue-based products (HCT/Ps), though the specific violations are referenced in the excerpted letter text provided. The products were purported to be sterile and intended for injection, with FIOR Bioscience LLC (co-located at the same facility) serving as the direct distributor to healthcare professionals and medical facilities.