1065109
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |