FDA Inspection 1206222 — Medtronic Neuromodulation
The FDA completed an inspection of Medtronic Neuromodulation on May 5, 2023 in Minneapolis, MN. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 5, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |