FDA inspection
Ellex iScience, Inc.: FDA inspection ending Dec 7, 2018
FDA inspection 1094990 · Voluntary Action Indicated (VAI) · Fremont, CA
Key facts
| Inspection ID | 1094990 |
|---|---|
| Firm | Ellex iScience, Inc. |
| FEI number | 3005641545 |
| Address | 41316 Christy St |
| City | Fremont |
| State | CA |
| ZIP | 94538-3115 |
| Fiscal year | 2019 |
| Inspection end date | Dec 7, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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