Atlas

Form 483

Boston Scientific Corporation Form 483, 2014-09-17

FDA issued a Form 483 to Boston Scientific Corporation on 2014-09-17 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Boston Scientific Corporation · Saint Paul, United States · Issued September 17, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Sep 2014
21 CFR 812.40

Sponsors' general responsibilities

Cited by Sharon L Matson

17 Sep 2014
21 CFR 812.150(b)(2)

Sponsor notification of IRB approval withdrawal

Cited by Sharon L Matson

Inspected site

BSBoston Scientific CorporationSaint Paul, United States

Inspection team

SLSharon L Matson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.150(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 812.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere