FDA 483 - Tira Chaicha-Brom, M.D. - June 11, 2019

Tira Chaicha-Brom, M.D. in Austin, TX, a clinical investigator, received a Form 483 following an FDA inspection. The inspection revealed that the firm did not conduct an investigation in accordance with its protocol, specifically regarding the reporting of certain values. Additionally, the firm failed to maintain adequate and accurate case histories by not documenting pertinent data into the electronic case report forms (eCRF).