FDA inspection

GE Healthcare Japan Corporation: FDA inspection ending Sep 15, 2017

FDA inspection 1081180 · Voluntary Action Indicated (VAI) · Hino

Key facts

Inspection ID 1081180
Firm GE Healthcare Japan Corporation
FEI number 3002808529
Address Ge Herusukea.Japan ( Kabu -4 Chome 7-127, Asahigaoka
City Hino
Fiscal year 2017
Inspection end date Sep 15, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical 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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