FDA inspection

Dexcowin Co. Ltd.: FDA inspection ending Aug 31, 2017

FDA inspection 1024822 · Official Action Indicated (OAI) · Geumcheon

Key facts

Inspection ID 1024822
Firm Dexcowin Co. Ltd.
FEI number 3007065358
Address # 606 Woolim Lions Valley Ii
City Geumcheon
Country Korea (the Republic of)
Fiscal year 2017
Inspection end date Aug 31, 2017
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 545388

At a glance

  • 10–99 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

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