FDA WARNING_LETTER - DePuy Orthopaedics, Inc. - June 07, 2011

FDA WARNING_LETTER for DePuy Orthopaedics, Inc. on June 07, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for DePuy Orthopaedics, Inc. on June 07, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 807.81(a)(3)

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

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

21 CFR 814.39(a)

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 812.3(b)

21 U.S.C. 360(k)

21 CFR 820.90(a)

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Record Information

Company

DePuy Orthopaedics, Inc.

Inspection Date

June 7, 2011

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 72fab4a0-5641-449b-88b6-ac1656e6f66e

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