Utah Cord Bank LLC
FDA issued a warning letter to Utah Cord Bank LLC (Sandy, UT) following a February 2021 inspection that identified significant deviations from 21 CFR Part 1271 regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps), specifically cord blood banking operations. The violations included failure to validate manufacturing processes, inadequate environmental monitoring, absence of required standard operating procedures across multiple operational areas, and incomplete recordkeeping. No marketing claims were flagged; the enforcement concerns centered entirely on manufacturing and quality-system deficiencies. FDA required a written corrective action response within 15 working days and warned that failure to correct violations could result in regulatory action without further notice.
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.
Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.
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