# FDA 483 - Luminopia Inc - May 02, 2025

Source: https://www.globalkeysolutions.net/records/483/luminopia-inc/b3d32f15-7f3c-41b0-9f00-f88d22055ce8

> FDA 483 for Luminopia Inc on May 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminopia Inc
- Inspection Date: 2025-05-02
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Luminopia Inc. in Cambridge, MA, from April 30 to May 2, 2025, revealed a significant quality system deficiency. The firm failed to maintain device history records for its Luminopia SaMD product and lacked a documented procedure for them, despite having distributed over (b)(4) units. This indicates a fundamental breakdown in documenting the production process for a medical device.

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/luminopia-inc/87a7149c-d5ef-4106-824e-f28304e12e12

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144