Yiwei Li
FDA investigator
Appears on 7 documents from 2023 to 2025, most often at sites in China. Most often cites general requirements (21 CFR 211.160).
- 7
- Documents on file
- 9.0
- Observations per 483
- 2023
- First seen
- 2025
- Most recent
What they cite most
From 62 observations- 21 CFR 211.160General requirements10
- 21 CFR 211.192Production record review10
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
Activity by year
2023: 2, 2024: 2, 2025: 3
Where
China 3 · North Carolina 2 · Indiana 1 · South Korea 1
Often inspects with
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-04-10 | 483 Aurolife Pharma LLCApr 10, 2025 · Durham, North Carolina | Durham, North Carolina | 11 | |
| 2025-03-24 | 483 Aurige Pharma LLCMar 24, 2025 · Durham, North Carolina | Durham, North Carolina | 11 | |
| 2025-01-17 | 483 Bio-Thera Solutions, LtdJan 17, 2025 · Huangpu Di strict, China | Huangpu Di strict, China | 5 | |
| 2024-06-25 | 483 STgen Bio Co., Ltd.Jun 25, 2024 · Incheon, South Korea | Incheon, South Korea | — | |
| 2024-02-20 | 483 Simtra US LLCFeb 20, 2024 · Bloomington, Indiana | Bloomington, Indiana | 7 | |
| 2023-12-15 | 483 Suzhou Suncadia Biopharmaceuticals Co., Ltd.Dec 15, 2023 · Suzhou, China | Suzhou, China | 10 | |
| 2023-12-14 | 483 Suzhou Suncadia Biopharmaceuticals Co., LtdDec 14, 2023 · Suzhou, China | Suzhou, China | 10 |
About this profile
What does Yiwei Li inspect?
Yiwei Li appears on 7 documents on file covering 5 sites, most often in China.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.113.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Yiwei Li is dated Apr 10, 2025.