Atlas

FDA-Inspected Site

Virtual Radiologic Corporation

5 FDA inspections are on record for Virtual Radiologic Corporation in Edina, United States.

483· Form 483 issued

Edina, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-05.

At a glance

Inspections

5

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2026 – 5 Mar 2026Medical Devices & Rad Health483View 483 →
25 May 2022 – 26 May 2022Medical Devices & Rad HealthClean
7 Dec 2016 – 9 Dec 2016Medical Devices & Rad HealthClean
29 Oct 2012Not recordedClean
28 May 2010Not recordedClean

Observations on record

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

5 Mar 2026
ISO 13485:2016 Clause 6.1(a)

Resources for quality management system have not been determined or provided

Cited by Tyler R Courtney, Richard E Evoy

5 Mar 2026
ISO 13485:2016 Clause 6.2

Process(es) for personnel competence, training and awareness not documented

Cited by Tyler R Courtney, Richard E Evoy

5 Mar 2026
ISO 13485:2016 Clause 7.4.1

Procedures for purchasing process not documented

Cited by Tyler R Courtney, Richard E Evoy

5 Mar 2026
ISO 13485:2016 Clause 8.5.2

Corrective action not taken

Cited by Tyler R Courtney, Richard E Evoy

Investigators

FDA investigators tied to this site in the record.

Tyler R Courtney1 insp.
Richard E Evoy1 insp.
Christina L Bigham1 insp.
Yehualashe A Gessesse1 insp.
Marissa S Henning1 insp.
Tony T Yang1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 6.1(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Virtual Radiologic Corporation's 1 Form 483

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