FDA WARNING_LETTER - RenatiLabs Inc. - August 12, 2022

FDA WARNING_LETTER for RenatiLabs Inc. on August 12, 2022. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for RenatiLabs Inc. on August 12, 2022. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(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 CFR 211

21 CFR 1271.3(f)(1)

21 CFR 211.188(b)

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Record Information

Company

RenatiLabs Inc.

Inspection Date

August 12, 2022

Product Type

Biologics

Office

Division of Biological Products Operations I

People

Michael W. Roosevelt (Program Division Director)

ID: 92c62aa3-28d1-4974-bcca-b6a4457e2cf0

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