FDA Inspection 926041 - Neurolumen LLC - May 08, 2015

FDA Inspection 926041 for Neurolumen LLC on May 08, 2015. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 926041 for Neurolumen LLC on May 08, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17(a)(2)

21 CFR 820.100(a)

21 CFR 820.181

21 CFR 820.198(a)

21 CFR 820.200(a)

21 CFR 820.25(b)

21 CFR 820.40

21 CFR 820.50

21 CFR 820.80(e)

21 CFR 820.90(a)

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Record Information

Company

Neurolumen LLC

Inspection Date

May 8, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: db3d4ddb-a757-454e-af69-6ffcb725bdb4

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