FDA WARNING_LETTER - Stratus BioSystems, LLC - November 10, 2021

FDA WARNING_LETTER for Stratus BioSystems, LLC on November 10, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Stratus BioSystems, LLC on November 10, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 262(a)

21 CFR 211.113(b)

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

21 CFR 1271

21 CFR 211.166(a)

21 CFR 1271.10(a)(2)

21 CFR 211.160(b)

21 U.S.C. 355(i)

21 U.S.C. 262(i)

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Record Information

Company

Stratus BioSystems, LLC

Inspection Date

November 10, 2021

Product Type

Biologics

Office

Division of Biological Products Operations II

People

ID: 0b15ce19-51b1-4796-95b2-1380744e8cb2

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