FDA Inspection 998349 - Gauthier Biomedical, Inc. - December 15, 2016

FDA Inspection 998349 for Gauthier Biomedical, Inc. on December 15, 2016. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 998349 for Gauthier Biomedical, Inc. on December 15, 2016. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.18(b)(1)(i)

21 CFR 803.18(e)

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.50

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Record Information

Company

Gauthier Biomedical, Inc.

Inspection Date

December 15, 2016

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: ff0d4962-bdbc-473a-ade3-64e8b5824483

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