FDA inspection
Romark Global Pharma, LLC: FDA inspection ending Apr 27, 2020
FDA inspection 1123575 · Voluntary Action Indicated (VAI) · Manati, PR
Key facts
| Inspection ID | 1123575 |
|---|---|
| Firm | Romark Global Pharma, LLC |
| FEI number | 3012812524 |
| Address | State Road Pr-686 Km 0.5, Bo. Coto Norte |
| City | Manati |
| State | PR |
| ZIP | 00674 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Apr 27, 2020 |
| 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