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Form 483

US Vascular, Inc. Form 483, 2020-02-13

FDA issued a Form 483 to US Vascular, Inc. on 2020-02-13 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

US Vascular, Inc. · Beaverton, United States · Issued February 13, 2020

Overview

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

Inspectional observations

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

13 Feb 2020
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Paul M Kawamoto

13 Feb 2020
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Paul M Kawamoto

Inspected site

UVUS Vascular, Inc.Beaverton, United States

Inspection team

PMPaul M Kawamoto

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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