1015511
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |