# FDA 483 - Luminance Medical Ventures Incorporated - April 08, 2025

Source: https://www.keypedia.com/records/483/luminance-medical-ventures-incorporated/9ade501e-a5e4-4c71-8988-d4290f6f90b0

> FDA 483 for Luminance Medical Ventures Incorporated on April 08, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminance Medical Ventures Incorporated
- Inspection Date: 2025-04-08
- Product Type: devices
- Office Name: Dallas District Office
- Summary: An FDA inspection conducted at Luminance Medical Ventures Incorporated from April 3 to April 8, 2025, identified two significant observations detailed in a Form FDA-483. As a specification developer and complaint file establishment, the company was cited for deficiencies in its quality management system. The first observation concerned inadequate procedures for handling complaints. Specifically, not all complaints were uniformly recorded, and top management did not consistently approve the evaluation of reportability as stipulated by the company's own internal procedures. The second observation highlighted the absence of established procedures for corrective and preventive actions. This included a lack of defined processes for analyzing quality data to identify nonconformities, thoroughly investigating the root causes of quality problems, verifying the effectiveness of corrective actions, and ensuring the dissemination of information related to quality issues throughout the organization. These observations indicate areas where the company’s practices did not align with regulatory expectations for maintaining a robust quality system. Luminance Medical Ventures Incorporated has acknowledged these findings and committed to correcting the identified issues.

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.keypedia.com/companies/luminance-medical-ventures-incorporated/7264aa8e-b140-418f-b1c8-eb81ce238274

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