FDA inspection

MEDIKAN CO., LTD.: FDA inspection ending Aug 14, 2014

FDA inspection 893877 · Official Action Indicated (OAI) · Gangseo

Key facts

Inspection ID 893877
Firm MEDIKAN CO., LTD.
FEI number 3008624479
Address # 502 Gayang Technotown 217, Heojun-Ro, Gangseo-Gu
City Gangseo
Country Korea (the Republic of)
Fiscal year 2014
Inspection end date Aug 14, 2014
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: 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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