FDA inspection

Amgen Singapore Manufacturing Pte Ltd: FDA inspection ending May 14, 2024

FDA inspection 1244897 · Voluntary Action Indicated (VAI) · Singapore

Key facts

Inspection ID 1244897
Firm Amgen Singapore Manufacturing Pte Ltd
FEI number 3011255424
Address 1 Tuas View Drive
City Singapore
Fiscal year 2024
Inspection end date May 14, 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
  • 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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