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Utah Cord Bank LLC, a biologics manufacturer of human cord blood-derived cellular products, failed to validate critical manufacturing and microbiological testing processes for human cells, tissues, and cellular products (HCT/Ps) in violation of 21 CFR Part 1271. During a February 2021 inspection, FDA documented that the company did not adequately validate processes that cannot be fully verified by subsequent inspections and tests, nor did it properly validate microbiological testing procedures designed to prevent contamination and communicable disease transmission. These significant deviations from regulations governing HCT/P manufacturing covered products recovered from donors between May 2005 and February 2021.