FDA 483 - Yamil Canaan, M.D. - February 22, 2021

An FDA inspection of Yamil Canaan, M.D. in Coral Gables, FL, revealed significant deficiencies in maintaining accurate case histories for clinical study subjects. The investigator was cited for back-dating source documents, signing records for visits when not physically present at the research site, and failing to maintain original and contemporaneous source documents. These findings indicate serious concerns regarding data integrity and the proper conduct of clinical trials.