FDA EIR - Medtronic MiniMed, Inc. - March 10, 2023

FDA EIR for Medtronic MiniMed, Inc. on March 10, 2023. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Medtronic MiniMed, Inc. on March 10, 2023. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.198

21.U.S.C. 355(a)

21 CFR 820.30

21 CFR 211

21 CFR 820.100(a)

21 CFR 820.70(c)

21 CFR 820.198(a)

21 CFR 803

21 CFR 801.30(a)(3)

FD&C Act 505(a)

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Record Information

Company

Medtronic MiniMed, Inc.

Inspection Date

March 10, 2023

Product Type

devices

Office

Office of Medical Device and Radiological Health Operations, Division 3 – West

People

ID: f8c687cd-8b0e-4a31-9cc4-7e5e761196dd

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