FDA inspection
Shire Human Genetic Therapies, Inc.: FDA inspection ending Dec 18, 2025
FDA inspection 1297340 · Voluntary Action Indicated (VAI) · Lexington, MA
Key facts
| Inspection ID | 1297340 |
|---|---|
| Firm | Shire Human Genetic Therapies, Inc. |
| FEI number | 3009340644 |
| Address | 200, 300, 400 Shire Way |
| City | Lexington |
| State | MA |
| ZIP | 02421 |
| Country | United States |
| Fiscal year | 2026 |
| Inspection end date | Dec 18, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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