FDA inspection

Boston Scientific Cork, Ltd.: FDA inspection ending Jun 12, 2019

FDA inspection 1116871 · Voluntary Action Indicated (VAI) · Cork

Key facts

Inspection ID 1116871
Firm Boston Scientific Cork, Ltd.
FEI number 3002913962
Address Model Farm Road
City Cork
Fiscal year 2019
Inspection end date Jun 12, 2019
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
  • 10–99 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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