Company
United StatesMevion Medical Systems, Inc., Littleton, MA – FDA Inspections
Inspection records and compliance data for Mevion Medical Systems, Inc. in Littleton, Massachusetts. 6 FDA inspections on record, 3 Form 483s, last inspected October 09, 2024.
Company Profile
This profile covers Mevion Medical Systems, Inc. based in Littleton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected September 6, 2012. Last inspected October 9, 2024.
Most cited issue areas
- Failure to submit2 inspections
- Complaints1 inspection
- Failure to submit, distinct marking1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 9, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1251608 |
| March 5, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1120302 |
| August 24, 2018 | Not classified | Medical Devices & Rad Health | 1132619 |
| March 30, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1005904 |
| March 16, 2015 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 918036 |
| September 6, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 797581 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Mevion Medical Systems, Inc.
FEI Number
3007087027
Address
300 Foster St, Littleton, Massachusetts 01460, United States
Country
United States
ID: 46e83290-2c5b-48a6-bcc7-8ff0b44b7011