FDA inspection

Nikkiso Ltd - Shizuoka Plant: FDA inspection ending May 21, 2026

FDA inspection 1322202 · Voluntary Action Indicated (VAI) · Makinohara

Key facts

Inspection ID 1322202
Firm Nikkiso Ltd - Shizuoka Plant
FEI number 3002807721
Address 498 1, Shizuoka-Ken Shizutani;
City Makinohara
Country Japan
Fiscal year 2026
Inspection end date May 21, 2026
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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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