Overview
- 33 inspections across 29 sites are on record.
- 136 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-27.
At a glance
Inspections
33
Sites
29
Observations
136
Career since
Jan 2023
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| NeuroMetrix, Inc. | 27 May 2026 | Medical Devices & Rad Health | On file |
| Lynx Medical of NJ LLC | 24 Apr 2026 | Medical Devices & Rad Health | On file |
| DSRV, Inc | 27 Mar 2026 | Medical Devices & Rad Health | On file |
| ASEPTIKITS, LLC | 3 Dec 2025 | Medical Devices & Rad Health | On file |
| Scientia Vascular, Inc. | 11 Nov 2025 | Medical Devices & Rad Health | On file |
Sites inspected
NeuroMetrix, Inc.Rockaway, United States1 insp.
Lynx Medical of NJ LLCFranklin, United States1 insp.
DSRV, IncBudd Lake, United States1 insp.
ASEPTIKITS, LLCNorth Salt Lake, United States1 insp.
Scientia Vascular, Inc.West Valley City, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Matthew W Kyle3 shared
Frank J Marciniak3 shared
William R Chang3 shared
Jaro P Perera2 shared
Melissa A Zuppe2 shared
James R Montero1 shared
Colin E Tack1 shared
Jonathan Ho1 shared
Naakesh N Gomanie1 shared
Full investigator report
Get the verbatim findings behind Monica L Gutierrez's 136 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