FDA inspection

Fisher & Paykel Healthcare, Ltd.: FDA inspection ending Apr 13, 2016

FDA inspection 977358 · Voluntary Action Indicated (VAI) · Auckland

Key facts

Inspection ID 977358
Firm Fisher & Paykel Healthcare, Ltd.
FEI number 3002806988
Address 15 Maurice Paykel Place, East Tamaki
City Auckland
Fiscal year 2016
Inspection end date Apr 13, 2016
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical 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
  • 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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