914050
Rockwell Medical, Inc — FEI 3001236991
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 3, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |