483
Tira Chaicha-Brom, M.D.FDA 483 - Tira Chaicha-Brom, M.D. - June 11, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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).
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · dd4061e6-13fb-472f-9c41-b6fb23cd564e