FDA inspection
LumiQuick Diagnostics Inc.: FDA inspection ending Feb 24, 2014
FDA inspection 867537 · Official Action Indicated (OAI) · Santa Clara, CA
Key facts
| Inspection ID | 867537 |
|---|---|
| Firm | LumiQuick Diagnostics Inc. |
| FEI number | 3005984081 |
| Address | 2946 Scott Blvd |
| City | Santa Clara |
| State | CA |
| ZIP | 95054 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Feb 24, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 423587 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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