973354
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Port St Lucie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |