FDA 483 - Nana Barseghian, M.D./Amicis Research Center - February 16, 2024

An FDA inspection of Amicis Research Center in Northridge, CA, revealed significant deficiencies in the conduct of a clinical investigation for a COVID-19 drug. The firm failed to adhere to the investigational plan, maintain accurate case histories, and properly obtain informed consent from study participants. These issues indicate a lack of compliance with clinical trial protocols and regulatory requirements.