1217939
The Abraham J. And Phyllis Katz Cord Blood — FEI 3006718574
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Warrensville Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 9076 | 21 CFR 600.12(a) | Maintenance - concurrence |