FDA inspection

Samsung Biologics Co., Ltd.: FDA inspection ending May 27, 2025

FDA inspection 1269570 · Yeonsu

Key facts

Inspection ID 1269570
Firm Samsung Biologics Co., Ltd.
FEI number 3010479596
Address 300 Songdobaiodae-Ro
City Yeonsu
Fiscal year 2025
Inspection end date May 27, 2025
Project area Blood and Blood Products
Product type Biologics

At a glance

  • None Citations
  • None 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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