FDA WARNING_LETTER - Euro Diagnostica AB - January 19, 2017

FDA WARNING_LETTER for Euro Diagnostica AB on January 19, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Euro Diagnostica AB on January 19, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 352(t)(2)

21 CFR 803.3

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 806.2(k)

21 CFR 820.100(b)

21 CFR 820.198(a)

21 CFR 803

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Record Information

Company

Euro Diagnostica AB

Inspection Date

January 19, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 97b48702-50cb-453c-a7ce-6c8b00d75341

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