FDA WARNING_LETTER - Akron Formulations India Private Limited - October 15, 2024

FDA WARNING_LETTER for Akron Formulations India Private Limited on October 15, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Akron Formulations India Private Limited on October 15, 2024. 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)

FD&C Act 704(a)(4)

21 CFR 211

21 CFR 210

21 CFR 211.22(a)

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

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

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Record Information

Company

Akron Formulations India Private Limited

Inspection Date

October 15, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 8f026db0-c570-4057-899c-9d821054703d

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