Atlas

Form 483

Vascular Solutions, LLC (A Subsidiary of Teleflex) Form 483, 2010-05-10

FDA issued a Form 483 to Vascular Solutions, LLC (A Subsidiary of Teleflex) on 2010-05-10 with 3 public-safe observations.

483· Form 483 issued3 observations

Vascular Solutions, LLC (A Subsidiary of Teleflex) · Maple Grove, United States · Issued May 10, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

10 May 2010
21 CFR 812.40

Sponsors' general responsibilities

Cited by Denise L Burosh

10 May 2010
21 CFR 812.43(b)

Sponsor shipped devices to unqualified person(s)

Cited by Denise L Burosh

10 May 2010
21 CFR 812.150(b)(5)

Sponsor progress reports for non-significant risk study

Cited by Denise L Burosh

Inspected site

VSVascular Solutions, LLC (A Subsidiary of Teleflex)Maple Grove, United States

Inspection team

DLDenise L Burosh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.150(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 812.40Cited across public-safe Form 483 observations1x
21 CFR 812.43(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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