FDA WARNING_LETTER - EUROMI S.A. - January 15, 2015

FDA WARNING_LETTER for EUROMI S.A. on January 15, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for EUROMI S.A. on January 15, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.120

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

21 CFR 820.100(a)

21 CFR 803.50(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 U.S.C. 381(a)

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Record Information

Company

EUROMI S.A.

Inspection Date

January 15, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Jan B. Welch

ID: 0285476a-30fe-4d15-a413-18be1914319b

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