FDA inspection

Boston Scientific International BV: FDA inspection ending Oct 8, 2019

FDA inspection 1130719 · Kerkrade

Key facts

Inspection ID 1130719
Firm Boston Scientific International BV
FEI number 3005111382
Address Vestastraat 6
City Kerkrade
Fiscal year 2020
Inspection end date Oct 8, 2019
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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