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FDA Inspection
•Boston Scientific Corporation•February 2, 2012

Boston Scientific Corporation – FDA Inspection, Feb 2, 2012

Record Details

This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on February 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
Boston Scientific Corporation
Inspection Date
February 2, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · c7753230-06d0-433b-9d6b-cbaf67ab1a7a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
765387
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 812.40Sponsors" general responsibilities

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Boston Scientific Corporation

11
DateClassificationOfficeProject area
March 18, 2025NAICenter for Devices and Radiological HealthCompliance: Devices
July 28, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
November 16, 2018VAICenter for Devices and Radiological HealthBioresearch Monitoring
September 29, 2017Not classifiedMinneapolis District Office
April 27, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
View all 11 other inspections on the company page
Other documents for Boston Scientific Corporation
  • FDA Inspection 1265739 - 2025-03-18
  • FDA Inspection 1177235 - 2022-07-28
  • FDA Inspection 1071852 - 2018-11-16
  • FDA Inspection 1047556 - 2017-09-29
  • FDA Inspection 1019833 - 2017-04-27

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