FDA WARNING_LETTER - MEDDEV USA, INC. - May 11, 2012

FDA WARNING_LETTER for MEDDEV USA, INC. on May 11, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MEDDEV USA, INC. on May 11, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360(j)

21 U.S.C. 360j(g)

21 U.S.C. 360(p)

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

21 CFR 820.30(a)

21 U.S.C. 360

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

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Record Information

Company

MEDDEV USA, INC.

Inspection Date

May 11, 2012

Product Type

Devices

Office

Department of Health and Human Services

People

ID: 21d96d39-f738-433f-9766-93af7b98f1c3

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