Overview
- 212 inspections across 178 sites are on record.
- 217 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2016-09-14.
At a glance
Inspections
212
Sites
178
Observations
217
Career since
Jan 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Stroma Medical Corporation | 14 Sep 2016 | Medical Devices & Rad Health | |
| Focal Therapeutics | 13 Sep 2016 | Medical Devices & Rad Health | |
| Trimedyne Inc | 25 Aug 2016 | Medical Devices & Rad Health | |
| Andwin Scientific | 27 Jul 2016 | Medical Devices & Rad Health | |
| R & D Medical Products, Inc. | 14 Jul 2016 | Medical Devices & Rad Health |
Sites inspected
Stroma Medical CorporationIrvine, United States1 insp.
Focal TherapeuticsAliso Viejo, United States1 insp.
Trimedyne IncIrvine, United States1 insp.
Andwin ScientificSimi Valley, United States1 insp.
R & D Medical Products, Inc.Lake Forest, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Greg K Keshishyan7 shared
Uttaniti Limchumroon4 shared
Sarah A Hassas3 shared
Kelvin Cheung3 shared
Jennifer M Gogley3 shared
Juanita Banuelos2 shared
Jocelyn E Massey2 shared
John R Myung2 shared
Sonya L Karsik2 shared
Wendy R Blame2 shared
Full investigator report
Get the verbatim findings behind James R Fleckenstein's 217 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