FDA WARNING_LETTER - Kootenai Medical Center IRB - May 29, 2013

FDA WARNING_LETTER for Kootenai Medical Center IRB on May 29, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Kootenai Medical Center IRB on May 29, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 50.51

21 CFR 812

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

21 CFR 56.108(c)

21 CFR 56.111(c)

21 CFR 56.115(a)(6)

21 CFR 50

21 CFR 56.115(a)(5)

21 CFR 50.52

21 CFR 56.109(f)

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Record Information

Company

Kootenai Medical Center IRB

Inspection Date

May 29, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: db46a7a6-e2b8-41be-9939-3e2a4c787e75

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