FDA Inspection
Mevion Medical Systems, Inc.Mevion Medical Systems, Inc. – FDA Inspection, Mar 16, 2015
Record Details
This FDA Inspection record concerns Mevion Medical Systems, Inc., with an inspection on March 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mevion Medical Systems, Inc.
- Inspection Date
- March 16, 2015
- Product Type
- Devices
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ID · de4ddd56-ee1c-47c8-a627-8c3b4248d548
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918036
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
3- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mevion Medical Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2024 | Not classified | New England District Office | Compliance: Medical Devices |
| 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 |
| 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 1251608 - 2024-10-09
- FDA Inspection 1120302 - 2020-03-05
- FDA Inspection 1132619 - 2018-08-24
- FDA Inspection 1005904 - 2017-03-30
- FDA Inspection 797581 - 2012-09-06
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