FDA inspection

Boston Scientific Corporation: FDA inspection ending May 7, 2014

FDA inspection 887387 · Voluntary Action Indicated (VAI) · Dorado, PR

Key facts

Inspection ID 887387
Firm Boston Scientific Corporation
FEI number 2648729
Address 12 Carr 698
City Dorado
State PR
ZIP 00646
Country United States
Fiscal year 2014
Inspection end date May 7, 2014
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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