FDA WARNING_LETTER - MAKRA KOZMETIKA D.O.O. - April 12, 2024

FDA WARNING_LETTER for MAKRA KOZMETIKA D.O.O. on April 12, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MAKRA KOZMETIKA D.O.O. on April 12, 2024. 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

21 CFR 211.165(a)

21 CFR 210

21 CFR 211.22(a)

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

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

21 CFR 211.84(d)(1)

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Record Information

Company

MAKRA KOZMETIKA D.O.O.

Inspection Date

April 12, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: cf17d5aa-caf2-4a23-b665-36effb093aae

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