FDA inspection
Terumo Cardiovascular Systems Corporation: FDA inspection ending Sep 15, 2016
FDA inspection 986107 · Voluntary Action Indicated (VAI) · Elkton, MD
Key facts
| Inspection ID | 986107 |
|---|---|
| Firm | Terumo Cardiovascular Systems Corporation |
| FEI number | 3000204839 |
| Address | 125 Blue Ball Rd |
| City | Elkton |
| State | MD |
| ZIP | 21921 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Sep 15, 2016 |
| 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
- 10–99 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