Overview
- 17 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-05.
At a glance
Inspections
17
Form 483s
11
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Oct 2025 – 5 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Dec 2023 – 21 Dec 2023 | Medical Devices & Rad Health | Clean | |
| 4 Dec 2023 – 14 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Sep 2022 – 29 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2021 – 27 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2020 – 6 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Apr 2017 – 26 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2015 – 14 Oct 2015 | Medical Devices & Rad Health | Clean | |
| 3 Feb 2014 – 21 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Apr 2013 – 30 May 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 17 Jan 2012 | Not recorded | Clean | |
| 29 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Eric J Heinze3 insp.
Mary R Hole3 insp.
Kenya Destin2 insp.
Elizabeth A Dakan2 insp.
Timothy C Grome2 insp.
Karen M Cruz Arenas1 insp.
Chad E Schmear1 insp.
Kristin M Abaonza1 insp.
Matthew M Vernon1 insp.
Matthew D Schnittker1 insp.
Christopher W Buser1 insp.
Jeffrey S Buckser1 insp.
James A Lane1 insp.
Amogh Pathi1 insp.
Mark E Chan1 insp.
Lance A Finnical1 insp.
Phillip M Pontikos1 insp.
Christine M Parmentier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | 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(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Intuitive Surgical, Inc.'s 11 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat