FDA inspection

GE OEC Medical Systems Gmbh: FDA inspection ending Nov 17, 2011

FDA inspection 762131 · Voluntary Action Indicated (VAI) · Wendelstein

Key facts

Inspection ID 762131
Firm GE OEC Medical Systems Gmbh
FEI number 3003283350
Address Wilhelm-Maisel-Str. 14
City Wendelstein
Country Germany
Fiscal year 2012
Inspection end date Nov 17, 2011
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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