FDA inspection
BK Meditech Co., Ltd.: FDA inspection ending Nov 21, 2013
FDA inspection 858496 · Voluntary Action Indicated (VAI) · Hwaseong
Key facts
| Inspection ID | 858496 |
|---|---|
| Firm | BK Meditech Co., Ltd. |
| FEI number | 3004176895 |
| Address | 58 Eunhaengnamu-Ro, Yanggam-Myeon |
| City | Hwaseong |
| Country | Korea (the Republic of) |
| Fiscal year | 2014 |
| Inspection end date | Nov 21, 2013 |
| 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