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•Taddese T. Desta, M.D.•November 22, 2019

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

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Record Details

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.

Company
Taddese T. Desta, M.D.
Inspection Date
November 22, 2019
Product Type
Drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Julian C. Hanson
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ID · ffe654ce-d7c2-4cae-ad06-c265af295808

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