FDA WARNING_LETTER - CHS - January 21, 2025

FDA WARNING_LETTER for CHS on January 21, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CHS on January 21, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

21 U.S.C. 321(g)

21 CFR 201.115(a)

21 U.S.C. 352(f)(1)

21 U.S.C. 353(b)

21 CFR 201.5

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Record Information

Company

CHS

Inspection Date

January 21, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Leigh Verbois (Director)

ID: d8d88535-4d5b-431c-b2ab-d8db4723b018

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