Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Nov 2025
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Kenya Destin, Karen M Cruz Arenas, Chad E Schmear
5 Nov 2025
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Kenya Destin, Karen M Cruz Arenas, Chad E Schmear
5 Nov 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kenya Destin, Karen M Cruz Arenas, Chad E Schmear
5 Nov 2025
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Kenya Destin, Karen M Cruz Arenas, Chad E Schmear
5 Nov 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Kenya Destin, Karen M Cruz Arenas, Chad E Schmear
Inspected site
ISIntuitive Surgical, Inc.Sunnyvale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
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