FDA WARNING_LETTER - Florida Atlantic University IRB - August 14, 2009

FDA WARNING_LETTER for Florida Atlantic University IRB on August 14, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Florida Atlantic University IRB on August 14, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812

21 CFR 50

21 CFR 50.25(a)(1)

21 CFR 50.25(a)(4)

21 CFR 56.108

21 CFR 56

21 CFR 50.25(a)(2)

21 CFR 56.109(b)

21 CFR 312

21 CFR 50.25

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Record Information

Company

Florida Atlantic University IRB

Inspection Date

August 14, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: beaa28d2-e04b-497f-aa46-189ff3a9a0c2

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