698189
CoreLink LLC — FEI 3006494201
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 12, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 512 | 21 CFR 820.65 | Traceability Lack of or inadequate {see also 820.120(e)} |