Overview
- 25 inspections across 24 sites are on record.
- 135 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-22.
At a glance
Inspections
25
Sites
24
Observations
135
Career since
Nov 2022
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Contego Medical, Inc | 22 May 2026 | Medical Devices & Rad Health | View 483 → |
| Micro-X Ltd. | 15 Jan 2026 | Medical Devices & Rad Health | View 483 → |
| 4DMedical Ltd. | 8 Jan 2026 | Medical Devices & Rad Health | View 483 → |
| Intuitive Surgical, Inc. | 5 Nov 2025 | Medical Devices & Rad Health | View 483 → |
| Diasol, Inc | 19 Aug 2025 | Medical Devices & Rad Health | View 483 → |
Sites inspected
Contego Medical, IncRaleigh, United States1 insp.
Micro-X Ltd.Tonsley, Australia1 insp.
4DMedical Ltd.Carlton, Australia1 insp.
Intuitive Surgical, Inc.Sunnyvale, United States1 insp.
Diasol, IncPhoenix, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Karen M Rodriguez14 shared
Kenya Destin3 shared
Javelle P Spann2 shared
Nikki S Bryant1 shared
Chad E Schmear1 shared
Scott D Stevens1 shared
Jacob G Lutz1 shared
Monica C Burgos Garcia1 shared
Joohi Castelvetere1 shared
Robert J Ham1 shared
Full investigator report
Get the verbatim findings behind Karen M Cruz Arenas' 135 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site