FDA inspection
TransMedics, Inc.: FDA inspection ending Sep 18, 2020
FDA inspection 1129937 · No Action Indicated (NAI) · Andover, Massachusetts
Key facts
| Inspection ID | 1129937 |
|---|---|
| Firm | TransMedics, Inc. |
| FEI number | 3003152463 |
| Address | 200 Minuteman Rd Ste 302 |
| City | Andover |
| State | Massachusetts |
| ZIP | 01810 |
| Fiscal year | 2020 |
| Inspection end date | Sep 18, 2020 |
| Classification | No Action Indicated (NAI) |
| Project area | Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: 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| Product type | Devices |
At a glance
- None Citations
- None 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