FDA WARNING_LETTER - Genetics & IVF Institute IRB - October 01, 2009

FDA WARNING_LETTER for Genetics & IVF Institute IRB on October 01, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genetics & IVF Institute IRB on October 01, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812

21 CFR 50

21 CFR 56.110(c)

21 CFR 56.120(b)(1)

21 CFR 56.115(a)(5)

21 CFR 56.120(b)(2)

21 CFR 56.109(f)

21 CFR 56

21 CFR 56.115(a)(3)

21 CFR 56.115(a)(2)

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Record Information

Company

Genetics & IVF Institute IRB

Inspection Date

October 1, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: c8b9269c-1051-48a5-8543-b8b7a4acbd62

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