Overview
- 10 inspections across 10 sites are on record.
- 7 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-22.
At a glance
Inspections
10
Sites
10
Observations
7
Career since
Dec 2018
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| JANSSEN BIOLOGICS B.V. | 22 May 2026 | Biologics | On file |
| Replimune, Inc. | 24 Apr 2025 | Biologics | On file |
| Vgxi Inc | 25 Nov 2024 | Biologics | On file |
| Catalent Anagni SRL | 25 Jun 2024 | Biologics | |
| Miltenyi Biotec, Inc | 3 May 2024 | Biologics | On file |
Sites inspected
JANSSEN BIOLOGICS B.V.Sassenheim, Netherlands1 insp.
Replimune, Inc.Woburn, United States1 insp.
Vgxi IncThe Woodlands, United States1 insp.
Catalent Anagni SRLAnagni, Italy1 insp.
Miltenyi Biotec, IncGaithersburg, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Meihong Liu3 shared
Laura K Demaster2 shared
Alifiya H Ghadiali2 shared
Jie He2 shared
Gene D Arcy2 shared
Stephanie J Val1 shared
Jessica Chery1 shared
Kevin J Matthews1 shared
Carla A Lorenzo1 shared
Guo-Chiuan Hung1 shared
Full investigator report
Get the verbatim findings behind Sharmila Shrestha's 7 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