Overview
- 9 inspections across 9 sites are on record.
- 7 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-04-24.
At a glance
Inspections
9
Sites
9
Observations
7
Career since
Dec 2018
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| 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 |
| Oxford Biomedica (US) LLC | 16 Feb 2024 | Biologics | On file |
Sites inspected
Replimune, Inc.Woburn, United States1 insp.
Vgxi IncThe Woodlands, United States1 insp.
Catalent Anagni SRLAnagni, Italy1 insp.
Miltenyi Biotec, IncGaithersburg, United States1 insp.
Oxford Biomedica (US) LLCDurham, 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
Carla A Lorenzo1 shared
Guo-Chiuan Hung1 shared
Bo Liang1 shared
Wei Wang1 shared
Y N Nguyen1 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