FDA inspection

Boston Scientific Corporation: FDA inspection ending Nov 18, 2021

FDA inspection 1156955 · Voluntary Action Indicated (VAI) · Saint Paul, MN

Key facts

Inspection ID 1156955
Firm Boston Scientific Corporation
FEI number 2124215
Address 4100 Hamline Ave N
City Saint Paul
State MN
ZIP 55112-5700
Fiscal year 2022
Inspection end date Nov 18, 2021
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices
Product type Devices

At a glance

  • 1–9 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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