Utah Cord Bank LLC dba Utah Cell Bank

Warning LetterOpen

Eliott D. Spencer, PhD Owner/President Utah Cord Bank LLC dba Utah Cell Bank 8675 S. Sandy Parkway, Suite 110 Sandy , UT 84070-6418 United StatesFEI 3005351861Issued Aug 10, 2021Office of Biological Products Operations - Division 2

View Letter

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.

Violations18

Issue DateAug 10, 2021

Product TypeBiologics

StatusOpen

Letter Details

Firm: Utah Cord Bank LLC dba Utah Cell Bank
Location: Eliott D. Spencer, PhD Owner/President Utah Cord Bank LLC dba Utah Cell Bank 8675 S. Sandy Parkway, Suite 110 Sandy , UT 84070-6418 United States
FEI Number: 3005351861
Country: United States
Issue Date: August 10, 2021
Issuing Office: Office of Biological Products Operations - Division 2
Product Type: Biologics
Status: Open

Summary

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.

Utah Cord Bank LLC dba Utah Cell Bank FDA Warning Letter, August 10, 2021