1272876
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Orleans, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12389 | 21 CFR 1271.220(c) | Specified requirements for in-process controls |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |