# FDA 483 - Neurolumen LLC - September 24, 2025

Source: https://www.keypedia.com/records/483/neurolumen-llc/965702a6-289b-4a32-8d47-823e87cfbc9f

> FDA 483 for Neurolumen LLC on September 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurolumen LLC
- Inspection Date: 2025-09-24
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Neurolumen LLC, a manufacturer of the Class II medical device Neurolumen PN-1000, revealed significant deficiencies in its quality system. The firm received three repeat observations concerning inadequate procedures for purchasing, complaint handling, and document control. These issues indicate a persistent failure to establish and implement essential quality management processes.

## Related Documents

- [WARNING_LETTER - 2013-12-13](https://www.keypedia.com/records/warning_letter/neurolumen-llc/489d5717-f6d9-49ec-99aa-09b244cb783f)

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/neurolumen-llc/2e53eb6e-6247-4069-ade9-cef49b1b8f04

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9