FDA inspection

Kyungwon Medical Co., Ltd.: FDA inspection ending Sep 20, 2012

FDA inspection 800237 · Official Action Indicated (OAI) · Osong-eup

Key facts

Inspection ID 800237
Firm Kyungwon Medical Co., Ltd.
FEI number 3006455376
Address 765, Jeongjungyeonje-ro
City Osong-eup
Country Korea (the Republic of)
Fiscal year 2012
Inspection end date Sep 20, 2012
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 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

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