FDA inspection
Duramed Pharmaceuticals Inc: FDA inspection ending Oct 19, 2000
FDA inspection 43107 · Official Action Indicated (OAI) · Somerset, NJ
Key facts
| Inspection ID | 43107 |
|---|---|
| Firm | Duramed Pharmaceuticals Inc |
| FEI number | 1000142873 |
| Address | 400 Campus Dr |
| City | Somerset |
| State | NJ |
| ZIP | 08873-1145 |
| Fiscal year | 2001 |
| Inspection end date | Oct 19, 2000 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | UCM069117 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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