FDA EIR - Melamed, Isaac R. , M.D. - November 08, 2018

An FDA inspection of clinical investigator Dr. Isaac R. Melamed was conducted from November 5-8, 2018, in Centennial, CO. This high-priority inspection, performed under FDA Compliance Program 7348.811 for Clinical Investigators, aimed to evaluate adherence to regulatory requirements for clinical trials. The inspection encompassed various areas, including informed consent, adverse event reporting, and investigational product accountability.

While no formal FDA Form 483 (Inspectional Observations) was issued, three significant issues were verbally discussed at the close-out meeting. These included the investigator's failure to sign specific sections of source documentation pertaining to investigational product dispensation, inadequate documentation for investigational product accountability where individual vial numbers were not properly linked to subject binders, and an initial failure to obtain assent from a minor subject, which was later corrected and reported. Dr. Melamed and his research manager committed to addressing these deficiencies. The investigator was reminded of his responsibilities under the Federal Food, Drug, and Cosmetic Act and the potential penalties for non-compliance, such as regulatory meetings or debarment from conducting clinical trials.