FDA WARNING_LETTER - Abbott Diabetes Care, Inc. - October 23, 2025

FDA WARNING_LETTER for Abbott Diabetes Care, Inc. on October 23, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Abbott Diabetes Care, Inc. on October 23, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 CFR 862.1355

21 CFR 820.250(a)

21 CFR 820.30(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 862.1355(b)(1)(ii)

21 U.S.C. 351(h)

21 CFR 820.30(g)

21 CFR 862.1355(b)(3)

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Record Information

Company

Abbott Diabetes Care, Inc.

Inspection Date

October 23, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 265995f4-6db4-487c-a763-8c6c9cae68db

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