FDA Inspection 1000914 - Cardiac Insight - February 10, 2017

FDA Inspection 1000914 for Cardiac Insight on February 10, 2017. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1000914 for Cardiac Insight on February 10, 2017. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 820.90(b)(2)

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Record Information

Company

Cardiac Insight

Inspection Date

February 10, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 05992d3f-fe94-41db-b4a5-5865b95b52ec

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