1094217
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Newark, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |