FDA Inspection 989881 - Somerset Medical Center IRB - September 30, 2016

FDA Inspection 989881 for Somerset Medical Center IRB on September 30, 2016. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 989881 for Somerset Medical Center IRB on September 30, 2016. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 56.107(e)

21 CFR 56.108(a)(1)

21 CFR 56.108(c)

21 CFR 56.115(a)(1)

21 CFR 56.115(a)(2)

21 CFR 56.115(a)(3)

21 CFR 56.115(a)(5)

21 CFR 56.115(b)

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Record Information

Company

Somerset Medical Center IRB

Inspection Date

September 30, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: bb94658b-2d76-4f78-b61e-01196e60225a

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