FDA WARNING_LETTER - Grupo Quimico SRL - November 22, 2023

FDA WARNING_LETTER for Grupo Quimico SRL on November 22, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Grupo Quimico SRL on November 22, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

21 CFR 211.160(b)

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

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

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

21 CFR 211.194(a)

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Record Information

Company

Grupo Quimico SRL

Inspection Date

November 22, 2023

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: caf7d721-08b4-42d9-8c37-37115927945f

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