FDA WARNING_LETTER - Westone Laboratories Incorporated - July 12, 2012

FDA WARNING_LETTER for Westone Laboratories Incorporated on July 12, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Westone Laboratories Incorporated on July 12, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.25(b)

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

21 CFR 820.70(c)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 820.198(a)

21 CFR 820.80(a)

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Record Information

Company

Westone Laboratories Incorporated

Inspection Date

July 12, 2012

Product Type

Devices

Office

Denver District Office

People

Latonya M. Mitchell (District Director)

ID: 0db1dac9-736e-4cdb-8149-370865737485

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