FDA Inspection 1036574 - ReShape Lifesciences, Inc. - December 18, 2017

FDA Inspection 1036574 for ReShape Lifesciences, Inc. on December 18, 2017. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1036574 for ReShape Lifesciences, Inc. on December 18, 2017. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.50(a)(1)

21 CFR 820.100(a)

21 CFR 820.22

21 CFR 820.30(g)

21 CFR 820.50

21 CFR 820.75(a)

21 CFR 820.90(a)

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Record Information

Company

ReShape Lifesciences, Inc.

Inspection Date

December 18, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: feb5d6d2-62f7-407c-accc-83f1f06b20bc

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