FDA inspection
Biovail Laboratories International SRL: FDA inspection ending Mar 19, 2008
FDA inspection 510773 · Voluntary Action Indicated (VAI) · Carolina, PR
Key facts
| Inspection ID | 510773 |
|---|---|
| Firm | Biovail Laboratories International SRL |
| FEI number | 2650179 |
| Address | Ave. Iturregui #34 Corner to B Street, Sabana Abajo Industrial Park |
| City | Carolina |
| State | PR |
| ZIP | 00984 |
| Fiscal year | 2008 |
| Inspection end date | Mar 19, 2008 |
| 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
- No 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