FDA Inspection 951141 - Edwards Lifesciences, LLC - November 20, 2015

FDA Inspection 951141 for Edwards Lifesciences, LLC on November 20, 2015. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 951141 for Edwards Lifesciences, LLC on November 20, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.184

21 CFR 820.75(b)(2)

21 CFR 820.80(d)

21 CFR 820.90(a)

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Record Information

Company

Edwards Lifesciences, LLC

Inspection Date

November 20, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fe69d8dd-17dd-43ae-bd85-8f33f6669daf

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