# FDA 483 - Thatthan Suksombooncharoen, MD - August 26, 2022

Source: https://www.keypedia.com/records/483/thatthan-suksombooncharoen-md/eaeb630f-c3cd-45cc-8835-72875338ba06

> FDA 483 for Thatthan Suksombooncharoen, MD on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Thatthan Suksombooncharoen, MD
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: The FDA inspected Thatthan Suksombooncharoen, MD, a clinical investigator in Chiang Mai, Thailand, from August 22-26, 2022. The inspection revealed a failure to prepare or maintain accurate case histories for study protocol D933AC00001 (TOPAZ-1). Specifically, the firm failed to report numerous concomitant medications and adverse events to the sponsor, and one adverse event was incorrectly reported, indicating significant data integrity issues in clinical trial conduct.

## Related Officers

- [investigator](https://www.keypedia.com/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)

Company: https://www.keypedia.com/companies/thatthan-suksombooncharoen-md/15f12554-b718-474a-8440-195361c83007

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4