Overview
- 6 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.
15 Jan 2026
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Sara M Onyango
15 Jan 2026
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Sara M Onyango
15 Jan 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Sara M Onyango
Inspected site
EMExpanse Medical Inc.Pleasanton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, 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