Nana Barseghian, M.D./Amicis Research Center – FDA Warning Letter, Feb 16, 2024

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Barseghian's clinical site from February 12-16, 2024, as part of the Bioresearch Monitoring Program. The inspection reviewed the conduct of clinical investigations, specifically Protocol (b)(4).

The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, specifically regarding subject eligibility criteria [21 CFR 312.60]. Protocol (b)(4) required the exclusion of subjects with a BMI ≥ 30 kg/m2. However, two subjects, (b)(6) (BMI 36.7 kg/m2) and (b)(6) (BMI 46.6 kg/m2), were enrolled and received investigational drug despite exceeding this BMI threshold.

The FDA acknowledged the February 26, 2024, written response from Dr. Barseghian, which stated that corrective and preventive actions (CAPAs) were initiated, including closer collaboration with the sponsor/CRO, ensuring the clinical research team's understanding of eligibility criteria, and retraining staff on protocol and BMI calculation. However, the FDA deemed the response inadequate due to insufficient details on the implementation of proposed procedures and practices to ensure protocol compliance and adequate oversight by the clinical investigator.

The FDA emphasized that the clinical investigator is ultimately responsible for ensuring studies adhere to the investigational plan and