Overview
- 80 inspections across 70 sites are on record.
- 165 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-06-09.
At a glance
Inspections
80
Sites
70
Observations
165
Career since
Aug 2021
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| JMBH HOLDINGS LLC | 9 Jun 2026 | Medical Devices & Rad Health | |
| Biowave Corporation | 26 May 2026 | Medical Devices & Rad Health | On file |
| Biorez, Inc | 13 May 2026 | Medical Devices & Rad Health | |
| Spine Wave, Inc. | 21 Apr 2026 | Medical Devices & Rad Health | |
| INTEGRATED MEDCRAFT LLC | 8 Apr 2026 | Medical Devices & Rad Health | On file |
Sites inspected
JMBH HOLDINGS LLCShelton, United States1 insp.
Biowave CorporationWestport, United States1 insp.
Biorez, IncNew Haven, United States1 insp.
Spine Wave, Inc.Shelton, United States1 insp.
INTEGRATED MEDCRAFT LLCEast Hampton, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Jeffrey J Thibodeau2 shared
Eric C Schmitt2 shared
Kwong P Lee2 shared
Stephen C Smith1 shared
Preston M Lee1 shared
Full investigator report
Get the verbatim findings behind Katarzyna Plona's 165 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