FDA inspection

Cochlear Limited: FDA inspection ending Apr 11, 2013

FDA inspection 829416 · Voluntary Action Indicated (VAI) · Lane Cove West

Key facts

Inspection ID 829416
Firm Cochlear Limited
FEI number 3002806740
Address 14 Mars Rd
City Lane Cove West
Country Australia
Fiscal year 2013
Inspection end date Apr 11, 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
  • 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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