FDA inspection
TransMedics, Inc.: FDA inspection ending Mar 14, 2019
FDA inspection 1082561 · Voluntary Action Indicated (VAI) · Andover, MA
Key facts
| Inspection ID | 1082561 |
|---|---|
| Firm | TransMedics, Inc. |
| FEI number | 3003152463 |
| Address | 200 Minuteman Rd Ste 302 |
| City | Andover |
| State | MA |
| ZIP | 01810 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 14, 2019 |
| 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