FDA 483 - Richard Hwang, MD - July 02, 2025

Richard Hwang, MD, a clinical investigator in El Paso, TX, was cited for significant deficiencies in conducting an investigational study and maintaining accurate case histories. The inspection revealed issues with subject enrollment criteria, adherence to study protocol for dose preparation, and the use of electronic systems for study management. Additionally, dose administration times were retrospectively recorded without proper source documentation, indicating a lack of data integrity.