FDA WARNING_LETTER - St Joseph Mercy Oakland IRB - April 22, 2013

FDA WARNING_LETTER for St Joseph Mercy Oakland IRB on April 22, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for St Joseph Mercy Oakland IRB on April 22, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812

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

21 CFR 56.108(c)

21 CFR 56.115(a)(6)

21 CFR 56.110

21 CFR 50

21 CFR 56.108(a)

21 CFR 56.115(a)(5)

21 CFR 56.107(d)

21 CFR 56

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Record Information

Company

St Joseph Mercy Oakland IRB

Inspection Date

April 22, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 86428f8a-5edc-4edf-b644-82d5cfd0a996

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