FDA inspection
American Regent, Inc.: FDA inspection ending Oct 29, 2014
FDA inspection 901719 · Voluntary Action Indicated (VAI) · Shirley, NY
Key facts
| Inspection ID | 901719 |
|---|---|
| Firm | American Regent, Inc. |
| FEI number | 2410375 |
| Address | 5 Ramsey Rd |
| City | Shirley |
| State | NY |
| ZIP | 11967 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Oct 29, 2014 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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