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

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.