FDA inspection

SAMSUNG MEDISON CO., LTD.: FDA inspection ending Jun 19, 2020

FDA inspection 1143792 · Voluntary Action Indicated (VAI) · Gumi

Key facts

Inspection ID 1143792
Firm SAMSUNG MEDISON CO., LTD.
FEI number 3009758186
Address 244 1gongdan-Ro
City Gumi
Fiscal year 2020
Inspection end date Jun 19, 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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