FDA inspection

Cochlear Americas Inc.: FDA inspection ending Aug 12, 2008

FDA inspection 531983 · No Action Indicated (NAI) · Lone Tree, CO

Key facts

Inspection ID 531983
Firm Cochlear Americas Inc.
FEI number 3005900820
Address 10350 Park Meadows Dr
City Lone Tree
State CO
ZIP 80124-6800
Fiscal year 2008
Inspection end date Aug 12, 2008
Classification No Action Indicated (NAI)
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None Citations
  • None 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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