Overview
- 8 inspections across 8 sites are on record.
- 6 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-03-20.
At a glance
Inspections
8
Sites
8
Observations
6
Career since
Sep 2023
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Bora Pharmaceuticals Injectables Inc | 20 Mar 2026 | Human Drugs | View 483 → |
| Alvotech HF | 4 Jul 2025 | Human Drugs | On file |
| Lonza AG | 4 Apr 2025 | Human Drugs | On file |
| Lonza AG | 4 Apr 2025 | Human Drugs | On file |
| Cilag AG | 23 Sep 2024 | Human Drugs | On file |
Sites inspected
Bora Pharmaceuticals Injectables IncBaltimore, United States1 insp.
Alvotech HFReykjavik, Iceland1 insp.
Lonza AGVisp, Switzerland1 insp.
Lonza AGVisp, Switzerland1 insp.
Cilag AGSchaffhausen, Switzerland1 insp.
Co-investigators
Investigators who share inspections with this person.
Thuy T Nguyen4 shared
Zhong Li3 shared
Melissa D Ray2 shared
Tekalign Wondimu1 shared
Brandy N Lepage1 shared
Sudipan Karmakar1 shared
Leiyun W Boone1 shared
Della Shin1 shared
Kathryn E King1 shared
Ekaterina Allen1 shared
Full investigator report
Get the verbatim findings behind Hyung-Yul Lee's 6 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site