FDA Inspection 1103549 — Medtronic Navigation, Inc.
The FDA completed an inspection of Medtronic Navigation, Inc. on Sep 30, 2019 in Lafayette, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Lafayette, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5206 | 21 CFR 1040.10(i) | Certified product modification |