1261762
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Peachtree Corners, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |