Yun Wu
FDA investigator
Appears on 5 documents from 2020 to 2023, most often at sites in North Carolina. Most often cites production record review (21 CFR 211.192).
- 5
- Documents on file
- 4.0
- Observations per 483
- 2020
- First seen
- 2023
- Most recent
What they cite most
From 20 observations- 21 CFR 211.192Production record review4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.67Equipment cleaning and maintenance2
Activity by year
2020: 2, 2021: 2, 2023: 1
Where
North Carolina 2 · Australia 1 · Singapore 1 · South Korea 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-10-17 | 483 Patheon Biologics Australia Pty LtdOct 17, 2023 · Woolloongabba, Australia | Woolloongabba, Australia | 2 | |
| 2021-08-24 | 483 Samsung Biologics Co., Ltd. 300 Songdo bio-daero, Yeonsu-guAug 24, 2021 · Incheon, South Korea | Incheon, South Korea | 1 | |
| 2021-04-21 | 483 Fujifilm Diosynth Biotechnologies USA, Inc.Apr 21, 2021 · Morrisville, North Carolina | Morrisville, North Carolina | 10 | |
| 2020-08-14 | 483 Patheon Manufacturing Services LLCAug 14, 2020 · Greenville, North Carolina | Greenville, North Carolina | 2 | |
| 2020-02-15 | 483 Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.Feb 15, 2020 · Singapore, Singapore | Singapore, Singapore | 5 |
About this profile
What does Yun Wu inspect?
Yun Wu appears on 5 documents on file covering 5 sites, most often in North Carolina.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 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 Yun Wu is dated Oct 17, 2023.