FDA EIR - Melamed, Isaac R. , M.D. - April 01, 2015

An FDA inspection of Isaac R. Melamed, M.D., known commercially as IMMUNOe International Research Centers, located in Centennial, Colorado, was conducted from March 9 to April 1, 2015. This thorough assessment, spanning thirteen days, aimed to evaluate the facility's adherence to regulatory standards for clinical research, particularly in the treatment of immunodeficiency disorders and asthma. FDA Investigator Linda M. Cherry led the inspection, engaging with key personnel including Global Research Director Ms. Burlleen Hewette and Dr. Isaac R. Melamed, the firm's CEO. A crucial finding from this comprehensive review was that no Form FDA-483, Inspectional Observations, was issued at the conclusion of the inspection. This outcome signifies that the FDA did not identify any objectionable conditions or practices that would necessitate formal corrective actions under its regulatory framework. Therefore, the report details no specific violations or required actions, indicating the company's operational compliance with established good clinical practices and regulatory expectations during the inspection period.