FDA inspection

Lake Region Medical, Ltd.: FDA inspection ending May 6, 2016

FDA inspection 978114 · Voluntary Action Indicated (VAI) · New Ross

Key facts

Inspection ID 978114
Firm Lake Region Medical, Ltd.
FEI number 3002807439
Address Father Butler Park
City New Ross
Country Ireland
Fiscal year 2016
Inspection end date May 6, 2016
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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