FDA 483 - Melamed, Isaac R. , M.D. - January 24, 2025

This FDA Form 483 was issued to Dr. Isaac R Melamed, M.D., a clinical investigator in Centennial, CO, following an inspection from January 15-24, 2025. The inspection revealed significant deficiencies in the conduct of a clinical investigation, including failure to adhere to the signed statement of investigator and inadequate maintenance of accurate case histories. These findings indicate serious concerns regarding patient eligibility determination, reporting of adverse events, and overall data integrity in the clinical trial.