Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
6 Mar 2020
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Eric J Heinze, Amogh Pathi
6 Mar 2020
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Eric J Heinze, Amogh Pathi
6 Mar 2020
21 CFR 803.50(b)(3)
Conducting an Investigation
Cited by James A Lane, Eric J Heinze, Amogh Pathi
6 Mar 2020
21 CFR 803.50(b)(3)
Conducting an Investigation
Cited by James A Lane, Eric J Heinze, Amogh Pathi
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 | 2x |
| 21 CFR 803.50(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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