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

Source: https://www.keypedia.com/records/483/richard-hwang-md/fc2a26c2-1e0b-4423-b170-b093b5d0c553

> FDA 483 for Richard Hwang, MD on July 02, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Richard Hwang, MD
- Inspection Date: 2025-07-02
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Audrey J. Yarbrough](https://www.keypedia.com/people/audrey-j-yarbrough/1bab3d1a-3246-451e-96fb-4ce52185e850)

Company: https://www.keypedia.com/companies/richard-hwang-md/259a8e83-5784-4d13-abf6-0500f826cbc9

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9