FDA 483 - Taddese T. Desta, M.D. - November 22, 2019

An FDA inspection of Taddese T. Desta, M.D. in San Diego, CA, a clinical investigator, revealed significant issues with data integrity and record-keeping during a Phase III clinical trial. The firm failed to maintain adequate and accurate case histories, with numerous discrepancies found between source documents and case report forms. This indicates a serious concern regarding the reliability of study data and compliance with regulatory requirements for clinical investigations.