FDA Inspection 1283200 - Neurolumen LLC - September 24, 2025

FDA Inspection 1283200 for Neurolumen LLC on September 24, 2025. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1283200 for Neurolumen LLC on September 24, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.198(a)

21 CFR 820.40

21 CFR 820.50

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Record Information

Company

Neurolumen LLC

Inspection Date

September 24, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 3a7d52b8-627e-46e2-b12e-874f2a76c683

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