Utah Cord Bank LLC

Warning LetterOpen

Eliott D. Spencer, Ph.D. President/Owner Utah Cord Bank LLC 8675 S Sandy Parkway, Bldg. 110 Sandy , UT 84070 United StatesFEI 3005351861Issued May 11, 2021Office Biological Products Operations – Division 2

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005351861.

Violations6

Issue DateMay 11, 2021

Product TypeBiologics

StatusOpen

Letter Details

Firm: Utah Cord Bank LLC
Location: Eliott D. Spencer, Ph.D. President/Owner Utah Cord Bank LLC 8675 S Sandy Parkway, Bldg. 110 Sandy , UT 84070 United States
FEI Number: 3005351861
Country: United States
Issue Date: May 11, 2021
Issuing Office: Office Biological Products Operations – Division 2
Product Type: Biologics
Status: Open

Summary

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.

Utah Cord Bank LLC FDA Warning Letter, May 11, 2021