960804
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 7, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mcallen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12271 | 21 CFR 1271.65(b)(2) | Prominently labeled (limited use) |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |