FDA WARNING_LETTER - Monmouth Medical Center IRB - April 20, 2015

FDA WARNING_LETTER for Monmouth Medical Center IRB on April 20, 2015. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Monmouth Medical Center IRB on April 20, 2015. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 50.51

21 CFR 56.108(c)

21 CFR 56.109(h)

21 CFR 50

21 CFR 50.50

21 CFR 56.107(a)

21 CFR 50.52

21 CFR 50.53

21 CFR 56

21 CFR 56.115(a)(2)

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Record Information

Company

Monmouth Medical Center IRB

Inspection Date

April 20, 2015

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

David C. Burrow (Director )

ID: 22efcaab-88a0-49f3-b04b-43ee9d696d20

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