Overview
- 2 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Shawn Choi
22 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Shawn Choi
Inspected site
TSTelevere Systems, LLCJanesville, United States
Inspection team
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 | 2x |
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