FDA Inspection 918036 — Mevion Medical Systems, Inc.
The FDA completed an inspection of Mevion Medical Systems, Inc. on March 16, 2015 in Littleton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Littleton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |