FDA WARNING_LETTER - LeMaitre Vascular, Inc. - April 16, 2025

FDA WARNING_LETTER for LeMaitre Vascular, Inc. on April 16, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LeMaitre Vascular, Inc. on April 16, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

21 U.S.C. 352(t)(2)

21 CFR 820.100(a)

21 CFR 820.70(c)

21 U.S.C. 321(h)

21 CFR 820.100(a)(4)

21 CFR 820.75(a)

21 CFR 806.10

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

LeMaitre Vascular, Inc.

Inspection Date

April 16, 2025

Product Type

Devices

Office

Office of Product Evaluation and Quality

People

Matthew G. Hillebrenner

ID: 3000c09b-7700-4856-95f0-dba90be8ec1e

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