FDA inspection
Somerset Caribe, Inc.: FDA inspection ending Mar 9, 2004
FDA inspection 316587 · Voluntary Action Indicated (VAI) · Caguas, PR
Key facts
| Inspection ID | 316587 |
|---|---|
| Firm | Somerset Caribe, Inc. |
| FEI number | 1000132457 |
| Address | Rte 156 Lot 24b, Km 58.5, Cagus West Ind. Park |
| City | Caguas |
| State | PR |
| ZIP | 00725 |
| Fiscal year | 2004 |
| Inspection end date | Mar 9, 2004 |
| 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
- 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