FDA WARNING_LETTER - Wayne State University IRB - February 02, 2010

FDA WARNING_LETTER for Wayne State University IRB on February 02, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Wayne State University IRB on February 02, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 56.108(c)

21 CFR 56.115(a)(5)

21 CFR 56.115(a)(2)

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Record Information

Company

Wayne State University IRB

Inspection Date

February 2, 2010

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: a558f286-7068-45c0-bfad-b1f370db3709

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