FDA inspection
Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe: FDA inspection ending Mar 10, 2020
FDA inspection 1120511 · Voluntary Action Indicated (VAI) · Dorado, PR
Key facts
| Inspection ID | 1120511 |
|---|---|
| Firm | Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe |
| FEI number | 3008171790 |
| Address | State Road 698 Km 0.8 Barrio Mameyal |
| City | Dorado |
| State | PR |
| ZIP | 646 |
| Fiscal year | 2020 |
| Inspection end date | Mar 10, 2020 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Generic Drug Evaluation |
| 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