1014229
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |