483
Mitchell Horwitz, M.D.FDA 483 - Mitchell Horwitz, M.D. - August 19, 2022
Record Details
An FDA inspection of Mitchell Horwitz, M.D., a clinical investigator in Durham, NC, revealed issues with data accuracy and record keeping. The inspection found that case histories were not accurately maintained, specifically regarding the reporting of concomitant medications in eCRFs for multiple subjects. This indicates a significant concern with the integrity of study data.
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- Atlanta District Office
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ID · 9a5a2f42-2fce-4bb6-9485-a04898567d0b