Actimus Biosciences Private Limited – FDA 483, Jan 25, 2024

ACTIMUS BIOSCIENCES LTD PVT, a biopharmaceutics clinical facility in Siripuram, Visakhapatnam, India, was cited for significant deficiencies during an FDA inspection. The observations primarily concern data integrity issues, failure to report adverse events, non-compliance with protocol-required subject confinement, unauthorized safety assessments, and inadequate record retention for echocardiogram images. These issues indicate a failure to conduct the clinical study DICH-039-22 in accordance with Good Clinical Practices, raising concerns about subject safety and data reliability.