FDA 483 - Piangwarin Phaosawasdi, M.D. - May 18, 2023

An FDA inspection of Amicis Research Center in Vacaville, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to study protocols, ensure proper informed consent for Spanish-speaking patients, maintain accurate case histories, and promptly report adverse events to both the IRB and the study sponsor. These issues highlight critical lapses in patient safety and regulatory compliance.