FDA inspection

Konan Medical Inc.: FDA inspection ending Apr 23, 2026

FDA inspection 1319306 · Voluntary Action Indicated (VAI) · Nishinomiya

Key facts

Inspection ID 1319306
Firm Konan Medical Inc.
FEI number 1000494121
Address 10-29, Miyanishi-Cho
City Nishinomiya
Country Japan
Fiscal year 2026
Inspection end date Apr 23, 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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