# FDA 483 - Illuminoss Medical Inc. - September 24, 2019

Source: https://www.globalkeysolutions.net/records/483/illuminoss-medical-inc/d6f9e380-6ecd-42eb-ae00-c0c32bfff308

> FDA 483 for Illuminoss Medical Inc. on September 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Illuminoss Medical Inc.
- Inspection Date: 2019-09-24
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Illuminoss Medical, a medical device manufacturer in East Providence, RI, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern failures in Medical Device Reporting (MDR), control of nonconforming product, supplier qualification, equipment suitability, and complaint handling procedures. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.

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## 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