FDA WARNING_LETTER - Dexcom, Inc. - November 07, 2024

FDA WARNING_LETTER for Dexcom, Inc. on November 07, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Dexcom, Inc. on November 07, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.75(b)

21 CFR 807.81(a)(3)

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

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

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Record Information

Company

Dexcom, Inc.

Inspection Date

November 7, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: f1c80d4f-168c-4052-9259-d522c918a7e1

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