FDA WARNING_LETTER - LXR Biotech, LLC - January 20, 2023

FDA WARNING_LETTER for LXR Biotech, LLC on January 20, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LXR Biotech, LLC on January 20, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211

21 CFR 211.165(a)

21 CFR 210

21 U.S.C. 351(a)(2)(B)

21 CFR 211.22

21 CFR 211.84(d)(1)

21 CFR 211.84(d)(2)

21 CFR 211.34

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Record Information

Company

LXR Biotech, LLC

Inspection Date

January 20, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations III

People

Jeffrey D. Meng (Associate Director)

ID: eae05c1d-b965-4d21-b3b4-40b380f20048

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