FDA WARNING_LETTER - LOKA BIOSCIENCES PRIVATE LIMITED - January 27, 2025

FDA WARNING_LETTER for LOKA BIOSCIENCES PRIVATE LIMITED on January 27, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LOKA BIOSCIENCES PRIVATE LIMITED on January 27, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 321(h)(1)

FD&C Act 520(g)

21 CFR 58

21 CFR 58.33(b)

21 CFR 58.31(f)

21 CFR 58.35(b)(5)

FD&C Act 201(h)(1)

21 CFR 58.81(a)

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Record Information

Company

LOKA BIOSCIENCES PRIVATE LIMITED

Inspection Date

January 27, 2025

Product Type

Devices

Office

Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)

People

Ouided Rouabhi (Acting Director)

ID: 51366532-43b0-401f-aaba-503ff49f37ce

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