FDA WARNING_LETTER - Cipla Limited - February 17, 2023

FDA WARNING_LETTER for Cipla Limited on February 17, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Cipla Limited on February 17, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 314.81(b)(1)(ii)

FD&C Act 801(a)(3)

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

21 CFR 211

21 U.S.C. 355(k)

21 CFR 210

21 CFR 211.192

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

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

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Record Information

Company

Cipla Limited

Inspection Date

February 17, 2023

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 4a179ebd-255d-4805-a6d2-4e500633be4e

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