FDA inspection
EKF Diagnostics, Inc. dba EFK Life Sciences: FDA inspection ending Oct 8, 2004
FDA inspection 356277 · Voluntary Action Indicated (VAI) · Elkhart, IN
Key facts
| Inspection ID | 356277 |
|---|---|
| Firm | EKF Diagnostics, Inc. dba EFK Life Sciences |
| FEI number | 1832837 |
| Address | 1814 Leer Dr |
| City | Elkhart |
| State | IN |
| ZIP | 46514-5447 |
| Fiscal year | 2005 |
| Inspection end date | Oct 8, 2004 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Med 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