FDA WARNING_LETTER - Steris Isomedix Services - January 08, 2014

FDA WARNING_LETTER for Steris Isomedix Services on January 08, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Steris Isomedix Services on January 08, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 820.20(b)

21 CFR 820.70(a)

21 CFR 820.100(b)

21 CFR 820.198(a)

21 CFR 820.20(c)

21 CFR 820.100(a)(2)

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Record Information

Company

Steris Isomedix Services

Inspection Date

January 8, 2014

Product Type

Devices

Office

Chicago District Office

People

ID: cc992909-757b-45cf-8735-2bb235382aec

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