FDA inspection
Thrombolex Inc: FDA inspection ending Mar 30, 2023
FDA inspection 1201201 · Voluntary Action Indicated (VAI) · New Britain, PA
Key facts
| Inspection ID | 1201201 |
|---|---|
| Firm | Thrombolex Inc |
| FEI number | 3015489145 |
| Address | 75 Britain Dr |
| City | New Britain |
| State | PA |
| ZIP | 18901 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Mar 30, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| 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