FDA inspection

Samsung Medison Co., Ltd: FDA inspection ending Jun 17, 2020

FDA inspection 1146171 · Voluntary Action Indicated (VAI) · Hongcheon

Key facts

Inspection ID 1146171
Firm Samsung Medison Co., Ltd
FEI number 3010289997
Address 3366 Hanseo-Ro, Nam-Myeon
City Hongcheon
Fiscal year 2020
Inspection end date Jun 17, 2020
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical 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

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