FDA WARNING_LETTER - St Jude Medical CRMD - October 17, 2012

FDA WARNING_LETTER for St Jude Medical CRMD on October 17, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for St Jude Medical CRMD on October 17, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.75(a)

21 CFR 820.30(f)

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

21 CFR 820.30(j)

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Record Information

Company

St Jude Medical CRMD

Inspection Date

October 17, 2012

Product Type

Devices

Office

Los Angeles District Office

People

ID: cfb9678b-04bd-492d-b298-caf2dac9ef19

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