FDA Inspection 1116412 - Children's Healthcare IRB #1 - January 31, 2020

FDA Inspection 1116412 for Children's Healthcare IRB #1 on January 31, 2020. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1116412 for Children's Healthcare IRB #1 on January 31, 2020. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 50.27(b)(2)

21 CFR 56.108(a)(1)

21 CFR 56.108(b)(1)

21 CFR 56.110(b)

21 CFR 56.115(a)(5)

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Record Information

Company

Children's Healthcare IRB #1

Inspection Date

January 31, 2020

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: fcd8c97a-8422-4aaa-a941-ef4f2698ccf9

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