FDA inspection
Diotech Co. Ltd.: FDA inspection ending Jul 28, 2017
FDA inspection 1020606 · Official Action Indicated (OAI) · Busan
Key facts
| Inspection ID | 1020606 |
|---|---|
| Firm | Diotech Co. Ltd. |
| FEI number | 3010969268 |
| Address | 212, Ildong-Jiaenin, Nakdongdero 301, Saha Gu |
| City | Busan |
| Country | Korea (the Republic of) |
| Fiscal year | 2017 |
| Inspection end date | Jul 28, 2017 |
| Classification | Official Action Indicated (OAI) |
| 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