Lei Zhang
FDA investigator
Appears on 4 documents from 2019 to 2025, most often at sites in Australia. Most often cites production record review (21 CFR 211.192).
- 4
- Documents on file
- 5.0
- Observations per 483
- 2019
- First seen
- 2025
- Most recent
What they cite most
From 20 observations- 21 CFR 211.192Production record review5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
Activity by year
2019: 1, 2023: 1, 2024: 1, 2025: 1
Where
Australia 1 · Iceland 1 · Rhode Island 1 · Switzerland 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-10-28 | 483 Lonza AGOct 28, 2025 · Visp, Switzerland | Visp, Switzerland | 4 | |
| 2024-03-08 | 483 CSL Behring (Australia) Pty LtdMar 8, 2024 · Broadmeadows, Australia | Broadmeadows, Australia | 4 | |
| 2023-03-17 | 483 Alvotech HfMar 17, 2023 · Reykjavik, Iceland | Reykjavik, Iceland | 8 | |
| 2019-04-19 | 483 Immunex Rhode Island CorporationApr 19, 2019 · West Greenwich, Rhode Island | West Greenwich, Rhode Island | 4 |
About this profile
What does Lei Zhang inspect?
Lei Zhang appears on 4 documents on file covering 4 sites, most often in Australia.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.68 and 21 CFR 211.100.
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 Lei Zhang is dated Oct 28, 2025.