Overview
- 24 inspections across 23 sites are on record.
- 127 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-01-15.
At a glance
Inspections
24
Sites
23
Observations
127
Career since
Nov 2022
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Micro-X Ltd. | 15 Jan 2026 | Medical Devices & Rad Health | On file |
| 4DMedical Ltd. | 8 Jan 2026 | Medical Devices & Rad Health | On file |
| Intuitive Surgical, Inc. | 5 Nov 2025 | Medical Devices & Rad Health | On file |
| Diasol, Inc | 19 Aug 2025 | Medical Devices & Rad Health | On file |
| Thoratec LLC | 30 May 2025 | Medical Devices & Rad Health | On file |
Sites inspected
Micro-X Ltd.Tonsley, Australia1 insp.
4DMedical Ltd.Carlton, Australia1 insp.
Intuitive Surgical, Inc.Sunnyvale, United States1 insp.
Diasol, IncPhoenix, United States1 insp.
Thoratec LLCPleasanton, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Karen M Rodriguez14 shared
Kenya Destin3 shared
Javelle P Spann2 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
Ulysses D Singleton1 shared
Full investigator report
Get the verbatim findings behind Karen M Cruz Arenas' 127 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