1100058
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- El Segundo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 9089 | 21 CFR 600.14(c) | When to report |