Overview
- 107 inspections across 102 sites are on record.
- 266 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2016-08-31.
At a glance
Inspections
107
Sites
102
Observations
266
Career since
Jan 2011
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Varian Medical Systems, Inc. | 31 Aug 2016 | Medical Devices & Rad Health | |
| Breast Microseed Inc | 22 Aug 2016 | Medical Devices & Rad Health | View 483 → |
| Natus Medical Incorporated | 27 Jul 2016 | Medical Devices & Rad Health | View 483 → |
| Ortho Kinetics Corp | 21 Apr 2016 | Medical Devices & Rad Health | |
| Diazyme Laboratories | 20 Apr 2016 | Medical Devices & Rad Health | View 483 → |
Sites inspected
Varian Medical Systems, Inc.Seattle, United States1 insp.
Breast Microseed IncMercer Island, United States1 insp.
Natus Medical IncorporatedSeattle, United States1 insp.
Ortho Kinetics CorpVista, United States1 insp.
Diazyme LaboratoriesPoway, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Lori J Silverstein5 shared
Cynthia L Gorveatt4 shared
Stephen R Souza4 shared
Paul M Kawamoto2 shared
Graham N Giesen2 shared
Daniel A Congdon2 shared
Katherine L Arnold2 shared
Christopher S Genther1 shared
Scott W Fox1 shared
Christopher R Czajka1 shared
Full investigator report
Get the verbatim findings behind Sharon I Gundersen's 266 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