FDA inspection

Sysmex Corporation: FDA inspection ending Jan 17, 2013

FDA inspection 817094 · Voluntary Action Indicated (VAI) · Kobe

Key facts

Inspection ID 817094
Firm Sysmex Corporation
FEI number 3002808301
Address 4 Chome 4-4, Nishi-Ku
City Kobe
Country Japan
Fiscal year 2013
Inspection end date Jan 17, 2013
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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

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