# Keun-Wook Lee, M.D., Ph.D. – FDA 483, May 22, 2026

Source: https://www.keypedia.com/records/483/keun-wook-lee-md-phd/3ea92e94-3d73-41db-853b-16be10f007b0

> FDA 483 for Keun-Wook Lee, M.D., Ph.D. on May 22, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Keun-Wook Lee, M.D., Ph.D.
- Inspection Date: 2026-05-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Keun-Wook Lee, M.D., Ph.D. in Seongnam, Gyeonggi, Korea, a clinical investigator site, revealed significant deficiencies in adverse event reporting and data accuracy. The firm failed to report numerous non-serious adverse events to the sponsor and did not maintain accurate case histories, leading to discrepancies between electronic medical records and electronic data capture systems. These findings indicate serious issues with clinical trial data integrity and compliance with study protocols.

## Related Officers

- [Mayar M. Mussa](https://www.keypedia.com/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.keypedia.com/companies/keun-wook-lee-md-phd/053ca4c4-fc31-4a43-8858-284ebbbea26b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8