FDA WARNING_LETTER - Agnesian Healthcare IRB - November 13, 2012

FDA WARNING_LETTER for Agnesian Healthcare IRB on November 13, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Agnesian Healthcare IRB on November 13, 2012. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 56.115(a)(1)

21 CFR 56.115(a)(6)

21 CFR 56.108(a)

21 CFR 56.115(a)(4)

21 CFR 56.108(b)

21 CFR 50.25(a)

21 CFR 56.115(a)(2)

21 CFR 56.109(b)

21 CFR 56.109(e)

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Record Information

Company

Agnesian Healthcare IRB

Inspection Date

November 13, 2012

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 9f316b26-17dd-4b31-89cd-27b2b6c9ec3b

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