FDA inspection
Baxalta US Inc.: FDA inspection ending Jul 1, 2021
FDA inspection 1146227 · Voluntary Action Indicated (VAI) · Social Circle, GA
Key facts
| Inspection ID | 1146227 |
|---|---|
| Firm | Baxalta US Inc. |
| FEI number | 3013980449 |
| Address | 505 Shire Pkwy |
| City | Social Circle |
| State | GA |
| ZIP | 30025 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Jul 1, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data