FDA WARNING_LETTER - Utah Cord Bank LLC - February 11, 2021

FDA WARNING_LETTER for Utah Cord Bank LLC on February 11, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Utah Cord Bank LLC on February 11, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

21 CFR 211.188(b)

21 CFR 211.166(a)

21 U.S.C. 355(i)

21 CFR 211.67(b)

21 CFR 1271.3(d)

21 CFR 1271.10(a)

21 CFR 1271.15

21 CFR 1271.10(a)(1)

21 CFR 1271.3(f)(1)

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Record Information

Company

Utah Cord Bank LLC

Inspection Date

February 11, 2021

Product Type

Biologics

Office

Office of Biological Products Operations - Division I

People

Karlton T. Watson (Program Division Director)

ID: 9460479c-44df-4bb6-9d0c-fe83dcd4b23f

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