Atlas

FDA-Inspected Site

US Vascular, Inc.

6 FDA inspections are on record for US Vascular, Inc. in Beaverton, United States.

483· Form 483 issued

Beaverton, United States · Last updated July 9, 2026

Overview

  • 6 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-03-06.

At a glance

Inspections

6

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Mar 2024 – 6 Mar 2024Medical Devices & Rad Health483View 483 →
10 Feb 2020 – 13 Feb 2020Medical Devices & Rad Health483View 483 →
18 Mar 2019 – 21 Mar 2019Medical Devices & Rad Health483View 483 →
26 Mar 2018 – 30 Mar 2018Medical Devices & Rad HealthWLView 483 →
11 Apr 2017 – 24 Apr 2017Medical Devices & Rad Health483View 483 →
21 Mar 2016 – 28 Mar 2016Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

6 Mar 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen R Souza

6 Mar 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen R Souza

6 Mar 2024
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Stephen R Souza

6 Mar 2024
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Stephen R Souza

6 Mar 2024
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Stephen R Souza

Investigators

FDA investigators tied to this site in the record.

Stephen R Souza3 insp.
James D Hildreth2 insp.
Paul M Kawamoto1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations11x
21 CFR 820.30(i)Cited across public-safe Form 483 observations11x
21 CFR 820.181Cited across public-safe Form 483 observations8x
21 CFR 820.40Cited across public-safe Form 483 observations7x
21 CFR 820.184Cited across public-safe Form 483 observations6x
21 CFR 820.198(a)Cited across public-safe Form 483 observations6x
21 CFR 820.22Cited across public-safe Form 483 observations6x
21 CFR 820.50Cited across public-safe Form 483 observations6x
21 CFR 820.90(a)Cited across public-safe Form 483 observations6x
21 CFR 803.17Cited across public-safe Form 483 observations4x
21 CFR 820.30(j)Cited across public-safe Form 483 observations4x
21 CFR 820.80(a)Cited across public-safe Form 483 observations4x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 820.20(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(b)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind US Vascular, Inc.'s 6 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat