FDA 483 - FIOR Bioscience LLC - January 06, 2023

FIOR Bioscience LLC in Sandy, UT, was cited for significant failures in quality control during the manufacture of biological stem cell products. The firm failed to thoroughly investigate multiple lots of human umbilical cord blood, tissue, and amniotic tissue products that failed post-manufacturing sterility testing. Critically, several of these non-sterile lots were distributed to customers, with one lot linked to an adverse event resulting in a recipient's hospitalization.