FDA Inspection 573578 - Staten Island University Hospital IRB - April 03, 2009

FDA Inspection 573578 for Staten Island University Hospital IRB on April 03, 2009. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 573578 for Staten Island University Hospital IRB on April 03, 2009. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 50.20

21 CFR 50.25(a)(1)

21 CFR 50.25(a)(3)

21 CFR 50.25(a)(6)

21 CFR 56.108(a)(1)

21 CFR 56.108(b)(1)

21 CFR 56.108(c)

21 CFR 56.115(a)(2)

21 CFR 56.115(a)(4)

21 CFR 56.115(a)(5)

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Record Information

Company

Staten Island University Hospital IRB

Inspection Date

April 3, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fa32d05c-3f2a-4d21-bcc6-8431465affb1

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