1015903
Acumed LLC — FEI 1000125930
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hillsboro, OR (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |