FDA inspection
Ophtec USA, Inc.: FDA inspection ending Jun 24, 2022
FDA inspection 1173082 · Voluntary Action Indicated (VAI) · Sunrise, FL
Key facts
| Inspection ID | 1173082 |
|---|---|
| Firm | Ophtec USA, Inc. |
| FEI number | 3001237787 |
| Address | 400 Sawgrass Corporate Pkwy Ste 220 |
| City | Sunrise |
| State | FL |
| ZIP | 33325 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Jun 24, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Devices |
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