FDA Inspection
Mevion Medical Systems, Inc.Mevion Medical Systems, Inc. – FDA Inspection, Oct 9, 2024
Record Details
This FDA Inspection record concerns Mevion Medical Systems, Inc., with an inspection on October 9, 2024, issued by the New England District Office, covering medical devices & rad health.
- Company
- Mevion Medical Systems, Inc.
- Inspection Date
- October 9, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 3c20c8b3-3ce9-4220-9923-f7d3c2600441
Inspection Facts
- Inspection number
- 1251608
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1040.10(h)(1)(iii)Legible reproductions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mevion Medical Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 24, 2018 | Not classified | New England District Office | |
| March 30, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2015 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 6, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Mevion Medical Systems, Inc.
- FDA Inspection 1120302 - 2020-03-05
- FDA Inspection 1132619 - 2018-08-24
- FDA Inspection 1005904 - 2017-03-30
- FDA Inspection 918036 - 2015-03-16
- FDA Inspection 797581 - 2012-09-06
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