Overview
- 2 public-safe observations are available for this inspection.
- 2 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 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Jordan I Abel, Sasha L Eckstein
5 Jun 2026
ISO 13485:2016 Clause 7.2.1
Requirements related to product not determined
Cited by Jordan I Abel, Sasha L Eckstein
Inspected site
SWSmart World LLCFremont, United States
Inspection team
SLSasha L Eckstein
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.2.1 | Cited across public-safe Form 483 observations | 1x |
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