947767
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |