FDA inspection

Omron Healthcare Co., Ltd: FDA inspection ending May 26, 2015

FDA inspection 932431 · Voluntary Action Indicated (VAI) · Matsusaka

Key facts

Inspection ID 932431
Firm Omron Healthcare Co., Ltd
FEI number 3002807674
Address Omuronherusukea (Kabu) Matsusakajigyosho, 1855-370; Kubo-Cho
City Matsusaka
Country Japan
Fiscal year 2015
Inspection end date May 26, 2015
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

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