FDA WARNING_LETTER - Baxter Healthcare Corporation - January 27, 2023

FDA WARNING_LETTER for Baxter Healthcare Corporation on January 27, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Baxter Healthcare Corporation on January 27, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 801(a)(3)

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

21 CFR 211.100(b)

21 CFR 211

21 CFR 210

21 CFR 211.192

21 U.S.C. 381(a)(3)

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

21 CFR 211.63

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Record Information

Company

Baxter Healthcare Corporation

Inspection Date

January 27, 2023

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 3e82bbf1-a8b1-4f5d-b6c9-799df5b13d62

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