FDA WARNING_LETTER - Copan ltalia - January 17, 2012

FDA WARNING_LETTER for Copan ltalia on January 17, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Copan ltalia on January 17, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.70(b)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 820.50(b)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.70(e)

21 CFR 820.40

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Record Information

Company

Copan ltalia

Inspection Date

January 17, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: ea19ea73-69c8-40f8-b970-93514a24b8de

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