# FDA 483 - Myung-Ju Ahn, M.D., Ph.D. - January 26, 2024

Source: https://www.globalkeysolutions.net/records/483/myung-ju-ahn-md-phd/1e7b76a4-e5ea-4408-b9ca-e8435c5194e6

> FDA 483 for Myung-Ju Ahn, M.D., Ph.D. on January 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Myung-Ju Ahn, M.D., Ph.D.
- Inspection Date: 2024-01-26
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Myung-Ju Ahn, M.D., Ph.D. in Seoul, Korea, revealed significant deviations from Good Clinical Practices during a Phase 2 study for small cell lung cancer. Observations included the enrollment of subjects who did not meet eligibility criteria and a widespread failure to report non-serious adverse events to the sponsor according to the study protocol timetable. These findings indicate serious concerns regarding data integrity and patient safety in the clinical trial.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)

Company: https://www.globalkeysolutions.net/companies/myung-ju-ahn-md-phd/1c8205d1-d111-4f0b-b024-a0925bf684c7

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd