FDA inspection

Samsung Biologics Co., Ltd.: FDA inspection ending Feb 28, 2023

FDA inspection 1201856 · Voluntary Action Indicated (VAI) · Yeonsu District

Key facts

Inspection ID 1201856
Firm Samsung Biologics Co., Ltd.
FEI number 3010479596
Address 300 Songdobaiodae-Ro
City Yeonsu District
Country Korea (the Republic of)
Fiscal year 2023
Inspection end date Feb 28, 2023
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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