FDA inspection
SunPolar International Co., Ltd: FDA inspection ending Dec 17, 2015
FDA inspection 958348 · Voluntary Action Indicated (VAI) · Changhua County
Key facts
| Inspection ID | 958348 |
|---|---|
| Firm | SunPolar International Co., Ltd |
| FEI number | 3008381219 |
| Address | 16 Xingye Rd., Fuxing Township |
| City | Changhua County |
| Country | Taiwan |
| Fiscal year | 2016 |
| Inspection end date | Dec 17, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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