FDA WARNING_LETTER - Les Encres LLC - April 01, 2025

FDA WARNING_LETTER for Les Encres LLC on April 01, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Les Encres LLC on April 01, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.198

21 CFR 820.25(b)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.100(b)

21 U.S.C. 360e(a)

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Record Information

Company

Les Encres LLC

Inspection Date

April 1, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Matthew G. Hillebrenner

ID: cabbbd66-4974-470a-b600-6c0730253009

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