FDA inspection
Laboratorios Roldan S.A.: FDA inspection ending Aug 19, 2016
FDA inspection 988744 · Voluntary Action Indicated (VAI) · Santo Domingo
Key facts
| Inspection ID | 988744 |
|---|---|
| Firm | Laboratorios Roldan S.A. |
| FEI number | 3003138396 |
| Address | Carretera Sanchez Av Independencia, KM 5 |
| City | Santo Domingo |
| Country | Dominican Republic (the) |
| Fiscal year | 2016 |
| Inspection end date | Aug 19, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None 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