1085521
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Washington, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |