Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
VRVirtual Radiologic CorporationEdina, United States
Inspection team
RERichard E Evoy
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 6.1(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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