# FDA 483 - Illuminoss Medical Inc. - November 02, 2022

Source: https://www.globalkeysolutions.net/records/483/illuminoss-medical-inc/bdba4b4a-3860-4a63-bfde-37c904039fcb

> FDA 483 for Illuminoss Medical Inc. on November 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Illuminoss Medical Inc.
- Inspection Date: 2022-11-02
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Illuminoss Medical Inc. in East Providence, RI, was inspected by the FDA from October 4 to November 2, 2022. The inspection revealed significant deficiencies in process validation, MDR reporting, corrective and preventive actions, design change control, and nonconforming product procedures. These issues indicate a lack of adequate quality system controls for their medical devices, including the Photodynamic Bone Stabilization Catheter System.

## Related Documents

- [483 - 2019-09-24](https://www.globalkeysolutions.net/records/483/illuminoss-medical-inc/d6f9e380-6ecd-42eb-ae00-c0c32bfff308)
- [483 - 2024-02-01](https://www.globalkeysolutions.net/records/483/illuminoss-medical-inc/fb146a6f-c89e-4164-bef5-8782d1d8a37c)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/illuminoss-medical-inc/bf6b1729-c8fd-44bc-bd27-d8f01b166468

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7