FDA inspection

Samsung Biologics Co., Ltd.: FDA inspection ending Jul 30, 2024

FDA inspection 1261652 · Voluntary Action Indicated (VAI) · Yeonsu

Key facts

Inspection ID 1261652
Firm Samsung Biologics Co., Ltd.
FEI number 3010479596
Address 300 Songdobaiodae-Ro
City Yeonsu
Fiscal year 2024
Inspection end date Jul 30, 2024
Classification Voluntary Action Indicated (VAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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