FDA inspection

COCHLEAR MALAYSIA SDN BHD: FDA inspection ending May 17, 2017

FDA inspection 1021927 · No Action Indicated (NAI) · Kuala Lumpur

Key facts

Inspection ID 1021927
Firm COCHLEAR MALAYSIA SDN BHD
FEI number 3013177549
Address Unit Ug-1, Upper Ground, 3 Vertical Podium
City Kuala Lumpur
Fiscal year 2017
Inspection end date May 17, 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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