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