FDA Inspection 961419 - Somnowell, Inc. - March 10, 2016

FDA Inspection 961419 for Somnowell, Inc. on March 10, 2016. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 961419 for Somnowell, Inc. on March 10, 2016. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.20(c)

21 CFR 820.22

21 CFR 820.30(i)

21 CFR 820.30(j)

21 CFR 820.40

21 CFR 820.50

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Record Information

Company

Somnowell, Inc.

Inspection Date

March 10, 2016

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f7129059-637c-4303-85ea-a368ae075731

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