# FDA 483 - Luminelle Inc - February 21, 2023

Source: https://www.globalkeysolutions.net/records/483/luminelle-inc/8091dce9-060f-4e8f-b24a-b47c504b5699

> FDA 483 for Luminelle Inc on February 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminelle Inc
- Inspection Date: 2023-02-21
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Luminelle Inc. in Raleigh, NC, was inspected by the FDA, revealing significant deficiencies in its quality system for medical devices. The inspection found failures in medical device reporting, complaint handling, risk analysis, design verification, supplier management, management review, and personnel training. These issues indicate a systemic breakdown in ensuring the safety and effectiveness of their Luminelle DTx Hysteroscopy/Cystoscopy System.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.globalkeysolutions.net/companies/luminelle-inc/69e06698-f12d-4400-91de-5a7eb8ea8f60

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7