FDA Inspection 1145034 — Medtronic Navigation, Inc.
The FDA completed an inspection of Medtronic Navigation, Inc. on June 29, 2021 in Lafayette, CO. 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
- June 29, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lafayette, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |