FDA Inspection 1036654 — Medtronic Navigation, Inc.-Boxborough
The FDA completed an inspection of Medtronic Navigation, Inc.-Boxborough on Jan 3, 2018 in Boxborough, MA. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 3, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boxborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |