FDA WARNING_LETTER - Zevex International, Inc. - January 05, 2010

FDA WARNING_LETTER for Zevex International, Inc. on January 05, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Zevex International, Inc. on January 05, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 803.50(a)(1)

21 CFR 820

21 CFR 806.10(a)(1)

21 U.S.C. 321(h)

21 CFR 806.10(b)

21 CFR 820.198(a)

21 CFR 820.20(c)

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Record Information

Company

Zevex International, Inc.

Inspection Date

January 5, 2010

Product Type

Devices

Office

Denver District Office

People

Latonya M. Mitchell (District Director)

ID: c61dfe9d-0a38-4b02-8519-ca79b7c106a6

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