Overview
- 67 inspections across 59 sites are on record.
- 111 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2024-08-27.
At a glance
Inspections
67
Sites
59
Observations
111
Career since
Mar 2015
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Genentech, Inc. | 27 Aug 2024 | Human Drugs | |
| Lonza Biologics, Inc. | 12 Jul 2024 | Human Drugs | On file |
| KBI Biopharma, Inc. | 18 Jun 2024 | Human Drugs | On file |
| KBI Biopharma, Inc. | 17 Jun 2024 | Human Drugs | |
| MSD Ireland (Carlow) | 28 May 2024 | Human Drugs | On file |
Sites inspected
Genentech, Inc.Oceanside, United States1 insp.
Lonza Biologics, Inc.Portsmouth, United States1 insp.
KBI Biopharma, Inc.Durham, United States1 insp.
KBI Biopharma, Inc.Durham, United States1 insp.
MSD Ireland (Carlow)Carlow, Ireland1 insp.
Co-investigators
Investigators who share inspections with this person.
Yi Wang4 shared
Jacek Cieslak3 shared
Zhong Li3 shared
Diane L Raccasi3 shared
Steven Fong3 shared
Kamal N Tiwari2 shared
Ayyappan Rathakrishnan2 shared
Olumide A Martins2 shared
Joseph A Piechocki2 shared
Arsen Karapetyan2 shared
Full investigator report
Get the verbatim findings behind Michael Shanks' 111 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