FDA Inspection 963291 — Medtronic Navigation, Inc.-Boxborough
The FDA completed an inspection of Medtronic Navigation, Inc.-Boxborough on Mar 17, 2016 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
- Mar 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boxborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 5017 | 21 CFR 1003.21(a) | Incomplete notification of affected persons |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |