FDA Inspection 1240926 — Medtronic Navigation, Inc.-Boxborough
The FDA completed an inspection of Medtronic Navigation, Inc.-Boxborough on Jun 11, 2024 in Boxborough, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 11, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Boxborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |