FDA WARNING_LETTER - Genetics & IVF Institute - June 30, 2009

FDA WARNING_LETTER for Genetics & IVF Institute on June 30, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genetics & IVF Institute on June 30, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812.40

21 CFR 812.25(e)

21 CFR 812.140(b)(1)

21 U.S.C. 321(h)

21 CFR 812.46(a)

21 CFR 812.100

21 CFR 50.27(a)

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Record Information

Company

Genetics & IVF Institute

Inspection Date

June 30, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy A. Ulatowski (Director)

ID: 87330f0c-dd60-4cf9-b4cc-49cd0c638a5d

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