FDA inspection
Bionet Co., Ltd.: FDA inspection ending Apr 21, 2011
FDA inspection 727569 · Official Action Indicated (OAI) · Anyang
Key facts
| Inspection ID | 727569 |
|---|---|
| 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 | 2011 |
| Inspection end date | Apr 21, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 197392 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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