# FDA 483 - Mevion Medical Systems, Inc. - March 05, 2020

Source: https://www.keypedia.com/records/483/mevion-medical-systems-inc/f053137f-b135-4d20-883b-409ac84e4f32

> FDA 483 for Mevion Medical Systems, Inc. on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mevion Medical Systems, Inc.
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Mevion Medical Systems, Inc. in Littleton, MA, a manufacturer of radiation therapy systems, revealed two significant observations. The firm failed to submit required annual reports for their radiation therapy system in 2018 and 2019. Additionally, the company did not maintain adequate records of electronic product radiation safety tests, specifically for a Class II laser product used in their system.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)
- [Emir Galevi](https://www.keypedia.com/people/emir-galevi/d99d0e13-df64-44a8-af6e-ef28ff50b5b9)

Company: https://www.keypedia.com/companies/mevion-medical-systems-inc/46e83290-2c5b-48a6-bcc7-8ff0b44b7011

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94