FDA Inspection
Mevion Medical Systems, Inc.Mevion Medical Systems, Inc. – FDA Inspection, Mar 30, 2017
Record Details
This FDA Inspection record concerns Mevion Medical Systems, Inc., with an inspection on March 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9101ef87-31e9-4198-8b71-ff93c658e96e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005904
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 1002.13Failure to submit
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 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 1251608 - 2024-10-09
- FDA Inspection 1120302 - 2020-03-05
- FDA Inspection 1132619 - 2018-08-24
- FDA Inspection 918036 - 2015-03-16
- FDA Inspection 797581 - 2012-09-06
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