FDA inspection

Roche Singapore Technical Operations Pte. Ltd.: FDA inspection ending Nov 14, 2025

FDA inspection 1321444 · Voluntary Action Indicated (VAI) · Singapore

Key facts

Inspection ID 1321444
Firm Roche Singapore Technical Operations Pte. Ltd.
FEI number 3007164129
Address 10 Tuas Bay Link
City Singapore
Country Singapore
Fiscal year 2026
Inspection end date Nov 14, 2025
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
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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