Overview
- 9 inspections across 8 sites are on record.
- 0 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-04-18.
At a glance
Inspections
9
Sites
8
Observations
0
Career since
Jun 2023
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Curium US LLC | 18 Apr 2025 | Human Drugs | On file |
| Aurolife Pharma LLC | 10 Apr 2025 | Human Drugs | On file |
| Bio-Thera Solutions, Ltd. | 17 Jan 2025 | Human Drugs | On file |
| Suzhou Suncadia Biopharmaceuticals Co., Ltd | 6 Jan 2025 | Human Drugs | On file |
| Samsung Biologics Co., Ltd. | 30 Jul 2024 | Human Drugs | On file |
Sites inspected
Curium US LLCNoblesville, United States1 insp.
Aurolife Pharma LLCDurham, United States1 insp.
Bio-Thera Solutions, Ltd.Guangzhou, China1 insp.
Suzhou Suncadia Biopharmaceuticals Co., LtdSuzhou, China1 insp.
Samsung Biologics Co., Ltd.Yeonsu District, Korea (the Republic of)1 insp.
Co-investigators
Investigators who share inspections with this person.
Jiangsong Jiang2 shared
Jeanne M Fringer2 shared
Laurimer Kuilan-Torres2 shared
Zhong Li2 shared
Carla J Lundi1 shared
Thuy T Nguyen1 shared
Andrea Franco1 shared
Charles Y Kuo1 shared
Ruo H Xu1 shared
Richard Ledwidge1 shared
Full investigator report
Get the verbatim findings behind Yiwei Li's inspection record
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