FDA Inspection 823910 — Medtronic Neuromodulation
The FDA completed an inspection of Medtronic Neuromodulation on April 3, 2013 in Minneapolis, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 3, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |