FDA WARNING_LETTER - Amgen, Inc. - June 17, 2013

FDA WARNING_LETTER for Amgen, Inc. on June 17, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Amgen, Inc. on June 17, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.50(a)

21 CFR 4

21 CFR 820.30(i)

21 U.S.C. 353(g)

21 U.S.C. 321(h)

21 U.S.C. 356C(a)(1)

21 U.S.C. 351(h)

21 CFR 3

21 CFR 820.30(j)

21 CFR 820.30(g)

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Record Information

Company

Amgen, Inc.

Inspection Date

June 17, 2013

Product Type

Devices

Office

Los Angeles District Office

People

ID: 980f4f23-54ec-4bfd-b859-cf7b7d38566c

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