FDA inspection

Nihon Kohden America Inc: FDA inspection ending Mar 14, 2006

FDA inspection 417784 · Voluntary Action Indicated (VAI) · Irvine, CA

Key facts

Inspection ID 417784
Firm Nihon Kohden America Inc
FEI number 2080783
Address 15353 Barranca Pkwy
City Irvine
State CA
ZIP 92618-2216
Fiscal year 2006
Inspection end date Mar 14, 2006
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Med 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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