Overview
- 4 inspections across 4 sites are on record.
- 3 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-02-27.
At a glance
Inspections
4
Sites
4
Observations
3
Career since
Mar 2019
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Societal CDMO Gainesville, LLC | 27 Feb 2026 | Human Drugs | On file |
| I 3 PHARMACEUTICALS, LLC | 3 Mar 2023 | Human Drugs | On file |
| Quagen Pharmaceuticals LLC | 15 Mar 2019 | Human Drugs | |
| Quagen Pharmaceuticals LLC | 15 Mar 2019 | Human Drugs | On file |
Sites inspected
Societal CDMO Gainesville, LLCGainesville, United States1 insp.
I 3 PHARMACEUTICALS, LLCWarminster, United States1 insp.
Quagen Pharmaceuticals LLCWest Caldwell, United States1 insp.
Quagen Pharmaceuticals LLCWest Caldwell, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Mesfin Abdi2 shared
Monika Borkowska2 shared
Yvesna C Blaise2 shared
Jennifer Lalama1 shared
Daniel J Min1 shared
Janet A Rajan1 shared
Full investigator report
Get the verbatim findings behind Amit Kokate's 3 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