1168008
CAREstream Medical Ltd — FEI 3010396502
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 27, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lake Mary, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |