FDA Inspection 1079147 - Indiana Orthopaedic Hospital, LLC IRB #1 - February 13, 2019

FDA Inspection 1079147 for Indiana Orthopaedic Hospital, LLC IRB #1 on February 13, 2019. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1079147 for Indiana Orthopaedic Hospital, LLC IRB #1 on February 13, 2019. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 56.107(c)

21 CFR 56.108(b)(3)

21 CFR 56.109(f)

21 CFR 56.110(c)

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Record Information

Company

Indiana Orthopaedic Hospital, LLC IRB #1

Inspection Date

February 13, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: b2bfa3d3-09b0-4103-9ab5-c22f49bbdff3

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