FDA inspection
Bionet Co., Ltd.: FDA inspection ending Feb 21, 2019
FDA inspection 1082597 · Voluntary Action Indicated (VAI) · Anyang
Key facts
| Inspection ID | 1082597 |
|---|---|
| Firm | Bionet Co., Ltd. |
| FEI number | 3003681187 |
| Address | 5f, Shinsegae I&C Digital Center, 61 Digital-Ro 31 Gil, Guro-Gu |
| City | Anyang |
| Country | Korea (the Republic of) |
| Fiscal year | 2019 |
| Inspection end date | Feb 21, 2019 |
| 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