FDA WARNING_LETTER - Beta Bionics, Inc - June 26, 2025

FDA WARNING_LETTER for Beta Bionics, Inc on June 26, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Beta Bionics, Inc on June 26, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 803.3(w)(3)

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

21 CFR 803.3(o)(2)(i)

21 CFR 806.1(b)

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 806.10(f)

21 CFR 803.50(a)

21 CFR 803.50(a)(1)

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Record Information

Company

Beta Bionics, Inc

Inspection Date

June 26, 2025

Product Type

devices

Office

Office of Regulatory Programs

People

ID: c618dde7-c17f-4ba7-9227-9c89777cd93c

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