FDA inspection

Cochlear Limited: FDA inspection ending May 5, 2017

FDA inspection 1020330 · No Action Indicated (NAI) · Macquarie University

Key facts

Inspection ID 1020330
Firm Cochlear Limited
FEI number 3009092818
Address 1 University Ave
City Macquarie University
Fiscal year 2017
Inspection end date May 5, 2017
Classification No Action Indicated (NAI)
Project area Compliance: Medical 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
  • 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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