FDA Inspection 585769 - Indiana Orthopaedic Hospital, LLC IRB #1 - May 27, 2009

FDA Inspection 585769 for Indiana Orthopaedic Hospital, LLC IRB #1 on May 27, 2009. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 585769 for Indiana Orthopaedic Hospital, LLC IRB #1 on May 27, 2009. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 50.25(a)(5)

21 CFR 56.108(a)(1)

21 CFR 56.108(c)

21 CFR 56.110(b)

21 CFR 56.115(a)(2)

21 CFR 56.115(a)(5)

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Record Information

Company

Indiana Orthopaedic Hospital, LLC IRB #1

Inspection Date

May 27, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 34de6aae-568d-4f3f-b5b8-4dcb7c211290

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