Overview
- 4 inspections across 4 sites are on record.
- 16 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-02-20.
At a glance
Inspections
4
Sites
4
Observations
16
Career since
Dec 2022
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Immucor, Inc. | 20 Feb 2025 | Biologics | View 483 → |
| Sifin Diagnostics GmbH | 19 Jun 2024 | Biologics | |
| Bio-Rad Medical Diagnostics GmbH | 14 Jun 2024 | Biologics | View 483 → |
| Ortho-Clinical Diagnostics, Inc. | 9 Dec 2022 | Biologics | View 483 → |
Sites inspected
Immucor, Inc.Peachtree Corners, United States1 insp.
Sifin Diagnostics GmbHBerlin, Germany1 insp.
Bio-Rad Medical Diagnostics GmbHDreieich, Germany1 insp.
Ortho-Clinical Diagnostics, Inc.Raritan, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Cody D Rickman3 shared
Meihong Liu3 shared
Kaarin M Slotte2 shared
Emilia A Sippert1 shared
Edward A Brunt1 shared
Creighton T Tuzon1 shared
Gene D Arcy1 shared
Full investigator report
Get the verbatim findings behind Kimberly M Bigler's 16 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