FDA WARNING_LETTER - Flux Lab Pte. Ltd. d/b/a The Fluxion - December 01, 2025

FDA WARNING_LETTER for Flux Lab Pte. Ltd. d/b/a The Fluxion on December 01, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Flux Lab Pte. Ltd. d/b/a The Fluxion on December 01, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360(j)

FD&C Act 510(p)

FD&C Act 502(o)

21 U.S.C. 360(p)

21 U.S.C. 360

FD&C Act 201(h)

21 U.S.C. 321(h)

FD&C Act 510

FD&C Act 510(j)

21 U.S.C. 352(o)

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Record Information

Company

Flux Lab Pte. Ltd. d/b/a The Fluxion

Inspection Date

December 1, 2025

Product Type

Devices

Office

Office of Health Technology 3 (Gastrorenal, ObGyn, General Hospital, and Urology Devices)

People

ID: fe6e7fd0-f6db-4f76-a027-6e58b20555e2

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