FDA inspection
SDI Diagnostics, Inc.: FDA inspection ending Sep 30, 2021
FDA inspection 1153251 · Voluntary Action Indicated (VAI) · South Easton, MA
Key facts
| Inspection ID | 1153251 |
|---|---|
| Firm | SDI Diagnostics, Inc. |
| FEI number | 1220253 |
| Address | 10 Hampden Dr |
| City | South Easton |
| State | MA |
| ZIP | 02375 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Sep 30, 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