572456
Children's Healthcare of Atlanta at Scottish Rite — FEI 1000014971
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9225 | 21 CFR 606.171 | Biological product deviation report |