FDA inspection
Helio USA Inc: FDA inspection ending Jul 6, 2016
FDA inspection 977018 · Voluntary Action Indicated (VAI) · San Jose, CA
Key facts
| Inspection ID | 977018 |
|---|---|
| Firm | Helio USA Inc |
| FEI number | 1000135119 |
| Address | 816 Charcot Ave |
| City | San Jose |
| State | CA |
| ZIP | 95131 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Jul 6, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 10–99 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