FDA Inspection 1320378 — Keun-Wook Lee, M.D., Ph.D.
The FDA completed an inspection of Keun-Wook Lee, M.D., Ph.D. on May 22, 2026 in Seongnam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Seongnam (Korea (the Republic of))
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 22728 | 21 CFR 312.64(b) | Safety Reports - Non-Serious Events |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |