FDA inspection
Diagnostics Direct LLC: FDA inspection ending Aug 30, 2017
FDA inspection 1023448 · Voluntary Action Indicated (VAI) · Stone Harbor, NJ
Key facts
| Inspection ID | 1023448 |
|---|---|
| Firm | Diagnostics Direct LLC |
| FEI number | 3009178048 |
| Address | 1 S Main St |
| City | Stone Harbor |
| State | NJ |
| ZIP | 08247 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Aug 30, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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