FDA 483 - Bionik, Inc. - February 10, 2020

An FDA inspection of Bionik, Inc. in Watertown, MA, a manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, with numerous incomplete CAPA files. Additionally, procedures for receiving, reviewing, and evaluating complaints were not properly established, leading to issues with CAPA justifications and inconsistent complaint processing.