FDA inspection

Nidek, Inc.: FDA inspection ending Jul 30, 2013

FDA inspection 842321 · Voluntary Action Indicated (VAI) · Lewisville, TX

Key facts

Inspection ID 842321
Firm Nidek, Inc.
FEI number 2936921
Address 47651 Westinghouse Dr
City Lewisville
State TX
ZIP 75056
Country United States
Fiscal year 2013
Inspection end date Jul 30, 2013
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
  • 10–99 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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