1150115
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |