FDA WARNING_LETTER - Edwards Lifesciences, LLC - February 22, 2013

FDA WARNING_LETTER for Edwards Lifesciences, LLC on February 22, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Edwards Lifesciences, LLC on February 22, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 U.S.C. 360j(g)

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

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 820.130

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Record Information

Company

Edwards Lifesciences, LLC

Inspection Date

February 22, 2013

Product Type

Devices

Office

Denver District Office

People

ID: 8f481d33-3635-4719-94f7-681d4094583b

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