FDA inspection

KANEKA MEDICAL VIETNAM Co.,Ltd.: FDA inspection ending Feb 13, 2025

FDA inspection 1260820 · Voluntary Action Indicated (VAI) · Thuan An

Key facts

Inspection ID 1260820
Firm KANEKA MEDICAL VIETNAM Co.,Ltd.
FEI number 3031550970
Address 35, Vsip Street 6, Vietnam - Singapore Industrial Park, An Phu Ward
City Thuan An
Country Vietnam
Fiscal year 2025
Inspection end date Feb 13, 2025
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 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

Browse all FDA inspections