FDA inspection
Shire Human Genetic Therapies, Inc.: FDA inspection ending Jan 20, 2017
FDA inspection 1004081 · Voluntary Action Indicated (VAI) · Lexington, MA
Key facts
| Inspection ID | 1004081 |
|---|---|
| Firm | Shire Human Genetic Therapies, Inc. |
| FEI number | 3009340644 |
| Address | 300 Shire Way |
| City | Lexington |
| State | MA |
| ZIP | 02421 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Jan 20, 2017 |
| 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