FDA WARNING_LETTER - Xo Biologix - January 05, 2024

FDA WARNING_LETTER for Xo Biologix on January 05, 2024. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Xo Biologix on January 05, 2024. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 352(a)

21 CFR 211

21 CFR 210

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

21 U.S.C. 321(g)(1)

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Record Information

Company

Xo Biologix

Inspection Date

January 5, 2024

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

People

Melissa J. Mendoza (Director)

ID: 22b8160b-8f52-4e31-bd0d-50453694c778

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