FDA Inspection 963291 - Medtronic Navigation, Inc.-Boxborough - March 17, 2016

FDA Inspection 963291 for Medtronic Navigation, Inc.-Boxborough on March 17, 2016. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 963291 for Medtronic Navigation, Inc.-Boxborough on March 17, 2016. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 1003.21(a)

21 CFR 1020.30(d)(1)

21 CFR 803.50(a)(2)

21 CFR 820.100(a)

21 CFR 820.30(f)

21 CFR 820.50(a)

21 CFR 820.80(a)

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Record Information

Company

Medtronic Navigation, Inc.-Boxborough

Inspection Date

March 17, 2016

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fea63321-b621-43a4-95f0-7b358823ef45

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