FDA inspection

Cochlear Americas Inc.: FDA inspection ending Aug 7, 2000

FDA inspection 37507 · Voluntary Action Indicated (VAI) · Lone Tree, CO

Key facts

Inspection ID 37507
Firm Cochlear Americas Inc.
FEI number 3005900820
Address 10350 Park Meadows Dr
City Lone Tree
State CO
ZIP 80124-6800
Fiscal year 2000
Inspection end date Aug 7, 2000
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: Med 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
  • 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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