FDA inspection
T2 Biosystems, Inc.: FDA inspection ending Sep 24, 2021
FDA inspection 1152910 · Voluntary Action Indicated (VAI) · Lexington, MA
Key facts
| Inspection ID | 1152910 |
|---|---|
| Firm | T2 Biosystems, Inc. |
| FEI number | 3010097867 |
| Address | 101 Hartwell Ave |
| City | Lexington |
| State | MA |
| ZIP | 02421 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Sep 24, 2021 |
| 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