Leiyun Boone
FDA investigator
Appears on 8 documents from 2021 to 2025, most often at sites in Germany. Most often cites control of microbiological contamination (21 CFR 211.113).
- 8
- Documents on file
- 5.1
- Observations per 483
- 2021
- First seen
- 2025
- Most recent
What they cite most
From 36 observations- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.188Batch production and control records2
Activity by year
2021: 1, 2022: 1, 2023: 3, 2024: 2, 2025: 1
Where
Germany 2 · Denmark 1 · Iceland 1 · Massachusetts 1 · Rhode Island 1 · Switzerland 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-07-04 | 483 Alvotech HfJul 4, 2025 · Reykjavik, Iceland | Reykjavik, Iceland | 10 | |
| 2024-11-12 | 483 FUJIFILM Diosynth Biotechnologies Denmark ApSNov 12, 2024 · Hillerod, Denmark | Hillerod, Denmark | 3 | |
| 2024-03-19 | 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Mar 19, 2024 · Ravensburg, Germany | Ravensburg, Germany | 4 | |
| 2023-06-09 | EIR Boehringer Ingelheim Biopharmaceuticals China Ltd.Jun 9, 2023 | — | — | |
| 2023-03-22 | 483 Rentschler Biopharma Inc.Mar 22, 2023 · Milford, Massachusetts | Milford, Massachusetts | 6 | |
| 2023-03-07 | 483 Rentschler Biopbanna SEMar 7, 2023 · Laupheim, Germany | Laupheim, Germany | 5 | |
| 2022-03-29 | 483 Biogen International GmbHMar 29, 2022 · Luterbach, Switzerland | Luterbach, Switzerland | 4 |
About this profile
What does Leiyun Boone inspect?
Leiyun Boone appears on 8 documents on file covering 8 sites, most often in Germany.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.100 and 21 CFR 211.160.
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 Leiyun Boone is dated Jul 4, 2025.