Overview
- 90 inspections across 79 sites are on record.
- 412 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2022-10-25.
At a glance
Inspections
90
Sites
79
Observations
412
Career since
Nov 2010
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Unik Orthopedics, Inc | 25 Oct 2022 | Medical Devices & Rad Health | |
| iHealth Labs, Inc. | 16 May 2022 | Medical Devices & Rad Health | |
| QOSTRONICS | 9 Nov 2021 | Medical Devices & Rad Health | |
| UCP Bioscience Inc | 17 Mar 2017 | Medical Devices & Rad Health | On file |
| Covidien, LLC | 20 Sep 2016 | Medical Devices & Rad Health | View 483 → |
Sites inspected
Unik Orthopedics, IncSan Jose, United States1 insp.
iHealth Labs, Inc.Sunnyvale, United States1 insp.
QOSTRONICSSan Jose, United States1 insp.
UCP Bioscience IncMilpitas, United States1 insp.
Covidien, LLCSunnyvale, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Randall F Albright3 shared
Frank P Bianco3 shared
Mark E Chan2 shared
Phillip M Pontikos2 shared
Eileen M Malecki1 shared
Elizabeth A Dakan1 shared
Eric J Heinze1 shared
Christopher W Buser1 shared
Sandra S Saniga1 shared
Jacqueline M Cleary1 shared
Full investigator report
Get the verbatim findings behind Mary R Hole's 412 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