FDA Inspection 645196 — Medtronic Navigation, Inc.
The FDA completed an inspection of Medtronic Navigation, Inc. on February 4, 2010 in Lafayette, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 4, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lafayette, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4189 | 21 CFR 820.198(a) | General |
| 738 | 21 CFR 803.52(a)(1) | Patient Name or Other Identifier |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |