Overview
- 187 inspections across 134 sites are on record.
- 238 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2015-09-24.
At a glance
Inspections
187
Sites
134
Observations
238
Career since
Jan 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| General Medical Merate S.p.A. | 24 Sep 2015 | Medical Devices & Rad Health | |
| Bionen S.A.S. | 17 Sep 2015 | Medical Devices & Rad Health | View 483 → |
| Coopervision Manaufacturing, Ltd. | 11 Sep 2015 | Medical Devices & Rad Health | View 483 → |
| Summit Medical Ltd. | 5 Aug 2015 | Medical Devices & Rad Health | View 483 → |
| Arrotek Medical Ltd | 30 Jul 2015 | Medical Devices & Rad Health | View 483 → |
Sites inspected
General Medical Merate S.p.A.Seriate, Italy1 insp.
Bionen S.A.S.Florence, Italy1 insp.
Coopervision Manaufacturing, Ltd.Fareham, United Kingdom1 insp.
Summit Medical Ltd.Cheltenham, United Kingdom1 insp.
Arrotek Medical LtdSligo, Ireland1 insp.
Co-investigators
Investigators who share inspections with this person.
Katelyn A Staub-Zamperini7 shared
Dennis R Hock6 shared
Marjorie L Davis3 shared
Norman Wong2 shared
Erica L Nicoll2 shared
Mary R Kirker1 shared
Brandi L Garbutt1 shared
Michael J Diskin1 shared
Full investigator report
Get the verbatim findings behind James M Odonnell's 238 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