FDA EIR - Morteza Marandi, M.D. - April 04, 2016

An FDA inspection of Morteza Marandi, M.D., operating as Radiant Clinical Research in Cerritos, CA, was conducted from March 21 to April 4, 2016. The inspection, carried out under Compliance Program 7348.811 for Clinical Investigators, focused on the conduct of a specific clinical protocol. The main violation, issued as an FDA 483 observation, cited the principal investigator for not conducting the investigation in accordance with the signed statement of investigator and investigational plan, referencing 21 CFR 312.60. Specifically, the firm failed to provide records documenting weekly phone or clinic contacts for 11 out of 13 randomized subjects in Phase C of the study, a requirement per the protocol. Management, including Dr. Marandi, indicated that these records were likely misplaced by a former employee. Additionally, a separate issue discussed during the close-out involved a sub-investigator performing required physical exams on subjects several months before being properly documented on the delegation log and FDA Form 1572. Dr. Marandi acknowledged this and committed to future correction. He also stated he would provide a written response to the FDA 483 observation within 15 business days. The FDA noted that potential legal sanctions, including a warning letter, could result if the observation is determined to be a violation.