FDA 483 - Donald J Garcia, Jr. M.D. - October 11, 2024

Donald J Garcia, Jr. M.D., a clinical investigator in Austin, TX, was cited by the FDA for failing to maintain accurate case histories during an inspection. The firm incorrectly transcribed CAPS5 data into electronic case report forms (eCRF), leading to discrepancies between source data and data submitted to the FDA. This indicates significant issues with data integrity and record-keeping practices.