FDA WARNING_LETTER - Vitti Labs, LLC - December 20, 2021

FDA WARNING_LETTER for Vitti Labs, LLC on December 20, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Vitti Labs, LLC on December 20, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.42(c)(10)(i)

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 CFR 211.84(a)

21 CFR 211.100(a-b)

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Record Information

Company

Vitti Labs, LLC

Inspection Date

December 20, 2021

Product Type

Biologics

Office

Office of Biological Products Operations - Division I

People

Karlton T. Watson (Program Division Director)

ID: 1da82eb5-852f-488f-9b98-138058363c02

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