FDA inspection
American Regent, Inc.: FDA inspection ending Mar 15, 2011
FDA inspection 713642 · Official Action Indicated (OAI) · Shirley, NY
Key facts
| Inspection ID | 713642 |
|---|---|
| Firm | American Regent, Inc. |
| FEI number | 2410375 |
| Address | 5 Ramsey Rd |
| City | Shirley |
| State | NY |
| ZIP | 11967 |
| Country | United States |
| Fiscal year | 2011 |
| Inspection end date | Mar 15, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 10–99 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