FDA Person
FDAHyung-yul Lee
View detailed information about Hyung-yul Lee, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 7 inspections of 7 companies, 2023–2026.
Inspections (7)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 20, 2026 | Bora Pharmaceuticals Injectables Inc | Not classified | Drug Quality Assurance | #1308344 |
| July 4, 2025 | Alvotech HF | Not classified | #1286888 | |
| April 4, 2025 | Lonza AG | Not classified | #1279014 | |
| September 23, 2024 | Cilag AG | Not classified | #1257059 | |
| February 27, 2024 | Celltrion Inc. | VAI | Drug Quality Assurance | #1233221 |
| December 7, 2023 | Intas Pharmaceuticals Ltd. | Not classified | #1229315 | |
| September 1, 2023 | Samsung Biologics Co., Ltd. | VAI | Drug Quality Assurance | #1218067 |
Documents (10)
- 483 · Samsung Biologics Co., Ltd. · September 1, 2023
- 483 · Intas Pharmaceuticals Ltd. · December 7, 2023
- 483 · Cilag AG · September 23, 2024
- 483 · Catalent Indiana, LLC · May 12, 2023
- 483 · Celltrion Inc. · February 27, 2024
- 483 · Intas Pharmaceuticals Limited · December 7, 2023
- 483 · Lonza AG · April 4, 2025
- 483 · Bora Pharmaceuticals Injectables Inc · March 20, 2026
- 483 · Alvotech HF. · July 4, 2025
- 483 · Alvotech HF · July 4, 2025
Frequently inspected with (10)
Thuy T. Nguyen
Investigator, Consumer Safety Officer
3 shared
Zhong Li
3 shared
Aditi Thakur
1 shared
Brandy N. Lepage
Consumer Safety Officer
1 shared
Cassandra L. Abellard
investigator
1 shared
Della Shin
Pharmaceutical Scientist
1 shared
Dogbeda F. Mackenzie
1 shared
Ekaterina Allen
Pharmaceutical Scientist
1 shared
Hao Kiet D Phan
1 shared
Jeffrey P. Raimondi
Consumer Safety Officer
1 shared
Person Information
Name
Hyung-yul Lee
Role
INVESTIGATOR
ID: a790a804-2e43-4901-8d7d-0c656c464f0f
Get More Insights
Access our comprehensive quality intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.
1.5M+ regulatory data points
Real-time compliance monitoring
Interactive analytics dashboard
Looking for more people? Our platform provides access to thousands of FDA people with advanced search and filtering capabilities.
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.