FDA Person
FDAYiwei Li
View detailed information about Yiwei Li, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 9 inspections of 8 companies, 2023–2025.
Inspections (9)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| April 18, 2025 | Curium US PET LLC | Not classified | #1277593 | |
| April 10, 2025 | Aurolife Pharma LLC | Not classified | #1265425 | |
| January 17, 2025 | Bio-Thera Solutions, Ltd. | Not classified | #1276553 | |
| January 6, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not classified | #1270404 | |
| July 30, 2024 | Samsung Biologics Co., Ltd. | Not classified | #1261652 | |
| June 25, 2024 | STgen Bio Co., Ltd. | Not classified | #1260020 | |
| February 20, 2024 | Baxter Pharmaceutical Solutions, LLC | Not classified | #1230675 | |
| December 14, 2023 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not classified | #1242894 | |
| June 16, 2023 | Beigene (Suzhou) Co., Ltd. | VAI | Drug Quality Assurance | #1217639 |
Documents (19)
- EIR · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · January 6, 2025
- EIR · Samsung Biologics Co., Ltd. · July 30, 2024
- 483 · Suzhou Suncadia Biopharmaceuticals Co. Ltd. · January 6, 2025
- 483 · FUJIFILM Diosynth Biotechnologies Texas, LLC · November 7, 2023
- 483 · Beigene (Suzhou) Co., Ltd. · June 16, 2023
- 483 · Curium US PET LLC · April 18, 2025
- 483 · Baxter Pharmaceutical Solutions, LLC · February 20, 2024
- 483 · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · January 6, 2025
- 483 · Aurolife Pharma LLC · April 10, 2025
- 483 · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · December 14, 2023
- 483 · Bio-Thera Solutions, Ltd. · January 17, 2025
- 483 · Boehringer Ingelheim BioPharmaceuticals (China) Ltd. · July 9, 2023
- 483 · Bio-Thera Solutions, Ltd. · February 8, 2024
- 483 · Chinese Peptide Company · February 3, 2026
- 483 · STgen Bio Co., Ltd. · June 25, 2024
- 483 · Boehringer Ingelheim Biopharmaceuticals (China) Ltd. · June 9, 2023
- 483 · Thermo Fisher Biopharma Services PTE. LTD · May 5, 2026
- 483 · Samsung Biologics Co., Ltd. · July 30, 2024
- 483 · Biocon Biologics Limited · April 29, 2026
Frequently inspected with (10)
Jiangsong Jiang
2 shared
Laurimer Kuilan-Torres
2 shared
Thuy T. Nguyen
Investigator, Consumer Safety Officer
2 shared
Zhong Li
2 shared
Abdollah Koolivand
1 shared
Andrea Franco
Pharmaceutical Scientist
1 shared
Carla J. Lundi
Senior Consumer Safety Officer
1 shared
Cassandra L. Abellard
investigator
1 shared
Charles Y. Kuo
issuing_officer
1 shared
Derek S. Smith
1 shared
Person Information
Name
Yiwei Li
ID: e5ea2c24-8e1e-43be-be23-e276b8848cff
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