FDA inspection

Sysmex RA Co., LTD: FDA inspection ending Apr 20, 2017

FDA inspection 1015622 · Voluntary Action Indicated (VAI) · Shiojiri

Key facts

Inspection ID 1015622
Firm Sysmex RA Co., LTD
FEI number 3010188766
Address 1850-3 Oazahirookano-Mura
City Shiojiri
Country Japan
Fiscal year 2017
Inspection end date Apr 20, 2017
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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