FDA EIR - Alireza Nami MD - September 18, 2020

An FDA inspection was conducted at Alireza Nami MD in Charlotte, NC, from September 14 to September 18, 2020. This "for-cause" inspection, prompted by a report of serious noncompliance, focused on the authority, administration, and conduct of clinical investigations, particularly Protocol ID-(b)(4), under Compliance Program 7348.811, which governs clinical investigators. Numerous significant violations were identified, including the failure to perform essential protocol-required procedures and assessments before administering investigational product, such as missing principal investigator assessments, subject questionnaires, and pharmacokinetic samples. There was insufficient or missing source documentation to verify subject eligibility, and required safety monitoring, like electrocardiograms and cardiac monitor data transmission, was not completed. Furthermore, an untrained study coordinator conducted study visits, and a subject was enrolled despite screening results falling below exclusion criteria. These findings were serious, especially considering a previous 2014 inspection also revealed deviations concerning drug disposition, informed consent, and source documentation. Although no FDA Form 483 (Inspectional Observations) was issued, the deficiencies, already addressed by the site's Corrective and Preventive Action (CAPA) plan, were extensively discussed. The FDA reminded Dr. Nami of the seriousness of the findings and advised continued process improvements to ensure compliance with regulations governing clinical trials under "505 of the Federal Food, Drug, and Cosmetic Act.