Overview
- 66 inspections across 65 sites are on record.
- 19 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-20.
At a glance
Inspections
66
Sites
65
Observations
19
Career since
Mar 2021
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Brett M. Mahon, M.D. | 20 May 2026 | Medical Devices & Rad Health | |
| Anum Abbas, M.B.B.S | 29 Apr 2026 | Human Drugs | |
| Douglas M. Smith, M.D. | 16 Apr 2026 | Human Drugs | |
| Astellas Pharma Global Development, Inc. | 3 Apr 2026 | Human Drugs | |
| IIT Research Institute | 13 Mar 2026 | Biologics |
Sites inspected
Brett M. Mahon, M.D.Chicago, United States1 insp.
Anum Abbas, M.B.B.SOmaha, United States1 insp.
Douglas M. Smith, M.D.Roseville, United States1 insp.
Astellas Pharma Global Development, Inc.Northbrook, United States1 insp.
IIT Research InstituteChicago, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Jeanne J Thai20 shared
Yuanyuan Li8 shared
Lori Gioia3 shared
Vidhi J Jani2 shared
Jasmine Y Wang2 shared
Lisa Hayka2 shared
Joanne M Schlossin1 shared
Muhammad Naiman1 shared
Rachel E Mcguigan1 shared
Daniel B Arrecis1 shared
Full investigator report
Get the verbatim findings behind Colleen E Burke's 19 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