FDA WARNING_LETTER - Sorin Group Deutschland GmbH - September 01, 2015

FDA WARNING_LETTER for Sorin Group Deutschland GmbH on September 01, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sorin Group Deutschland GmbH on September 01, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

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

21 CFR 820.30(i)

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 381(a)

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

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Record Information

Company

Sorin Group Deutschland GmbH

Inspection Date

September 1, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: d3e5738f-5583-4a69-9c4a-0fea22f0be7e

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